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BridgeBio (BBIO), Amgen Partner in Advanced Solid Tumors Study

BridgeBio (BBIO) forges an alliance with Amgen to evaluate their respective cancer drugs for the treatment of advanced solid tumors with KRAS G12C mutations. BridgeBio Pharma, Inc. BBIO announced that it has entered into a non-exclusive clinical collaboration agreement with Amgen AMGN to evaluate the combination of its investigational SHP2 inhibitor BBP-398 with the latter’s KRAS G12C inhibitor Lumakras in patients with KRAS G12C-mutated advanced solid tumors.Both BridgeBio and Amgen will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of the combination in a phase I/II study. The study will first determine dose escalation for the combination followed by dose expansion and optimization.Per the agreement terms, BridgeBio will be responsible for sponsoring the study while Amgen is responsible for the worldwide supply of Lumakras.Per management estimates, KRAS mutations account for approximately 17% of malignant tumors. BridgeBio believes that the combination of an SHP2 inhibitor with a KRAS G12C inhibitor has the potential to prevent oncogenesis. BridgeBio also plans to enter into similar collaborations with other entities to explore such combinations.Shares of BridgeBio have plunged 81.4% in the trailing 12 months compared with the industry’s 31.4% decline.Image Source: Zacks Investment ResearchBridgeBio is currently evaluating BBP-398 in a phase I study in solid tumor patients. BBIO is also evaluating BBP-398 as a monotherapy or in combination with other therapies to target patients having KRAS G12C mutations.Lumakras is an FDA approved therapy approved since May 2021 for advanced non-small cell lung cancer (NSCLC). The launch of Lumakras in the United States is off to an excellent start, while its label expansion studies are progressing rapidly. Amgen generated $36 million from Lumakras’ sales in third-quarter 2021.Another company that has a KRAS inhibitor in its pipeline is Mirati Therapeutics MRTX. Adagrasib, Mirati’s leading KRAS inhibitor candidate, is being studied both as a monotherapy and in combination in a phase I/II study (KRYSTAL) to treat patients with KRAS G12C-positive tumors.Last October, Mirati entered into a non-exclusive clinical collaboration agreement with Sanofi SNY. The collaboration will evaluate the combination of Mirati’s KRASG12C inhibitor adagrasib with Sanofi's investigational SHP2 inhibitor SAR442720 (also known as RMC-4630) in a phase I/II dose escalation and expansion study in previously treated NSCLC patients with KRAS G12C mutations.Per the agreement terms, Mirati and Sanofi will jointly oversee and share costs of the above study. However, Sanofi will be responsible for sponsoring and operating the study.BridgeBio Pharma, Inc. Price BridgeBio Pharma, Inc. price | BridgeBio Pharma, Inc. QuoteZacks RankBridgeBio carries a Zacks Rank #3 (Hold) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Infrastructure Stock Boom to Sweep America A massive push to rebuild the crumbling U.S. infrastructure will soon be underway. It’s bipartisan, urgent, and inevitable. Trillions will be spent. Fortunes will be made. The only question is “Will you get into the right stocks early when their growth potential is greatest?” Zacks has released a Special Report to help you do just that, and today it’s free. Discover 5 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.Download FREE: How to Profit from Trillions on Spending for Infrastructure >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Sanofi (SNY): Free Stock Analysis Report Amgen Inc. (AMGN): Free Stock Analysis Report Mirati Therapeutics, Inc. (MRTX): Free Stock Analysis Report BridgeBio Pharma, Inc. (BBIO): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksJan 14th, 2022

Nuvation (NUVB) Gets FDA Clearance for Oncology Candidate

Nuvation (NUVB) will be initiating a phase I/II study of NUV-868 as a monotherapy and in combination with Lynparza or Xtandi in multiple tumor types following IND clearance by the FDA. Nuvation Bio Inc. NUVB announced that the FDA has cleared its investigational new drug (IND) application to evaluate its pipeline candidate NUV-868., a BD2-selective oral small molecule bromodomain and extra-terminal (BET) inhibitor.The IND application has been cleared to evaluate the candidate for the treatment of advanced solid tumors, including ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC) and triple-negative breast cancer (TNBC). The candidate will be advanced into phase I development in mid-2022.Nuvation will be initiating a phase I/II study of NUV-868 as a monotherapy and in combination with Lynparza or Pfizer’s PFE  Xtandi in multiple tumor types.The company will begin a phase I monotherapy dose-escalation study in advanced solid tumor patients. Thereafter, a phase Ib study will be initiated evaluating NUV-868 in combination with Lynparza in previously treated ovarian cancer, pancreatic cancer, mCRPC and TNBC patients and in combination with Xtandi for mCRPC patients. The company will then initiate a phase IIb study to further explore safety and efficacy once the recommended phase II combination dose is determined. A phase II monotherapy study will also be initiated in mCRPC patients to further examine safety and efficacy.We note that Pfizer’s Xtandi is approved to treat three forms of prostate cancer in the United States.Per the company, preclinical studies have shown NUV-868 is almost 1,500 times more selective for BD2 than BD1. Non-selective BD1/2 inhibitors in development have been associated with tolerability issues, potentially due to too much BD1 inhibition.Shares of the company have plunged 49.4% in the past year compared with the industry’s decline of 38%.Image Source: Zacks Investment ResearchThe successful development of the candidate will be a significant boost for this clinical-stage biopharmaceutical company.Nuvation proprietary portfolio includes six novel and mechanistically distinct oncology therapeutic product candidates.Nuvation began treating high-grade glioma patients in a phase I/II study of NUV-422, its lead product candidate, in December 2020. The FDA has granted Fast Track designation to NUV-422, a cyclin-dependent kinase (CDK) 2/4/6 inhibitor, for the treatment of patients with high-grade gliomas, including glioblastoma multiforme. The candidate also received Orphan Drug Designation to treat patients with malignant gliomas from the FDA in the first quarter of 2021.Nuvation currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector are Vir Biotechnology VIR and Alkermes ALKS, each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.Earnings estimates for Vir have moved up $2.05 in the past 30 days for 2022. VIR has gained 100.4% in the past two years.Earnings estimates for Alkermes have moved up a cent for 2022 in the past 60 days. ALKS has jumped 30.9% in the past year.  5 Stocks Set to Double Each was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2021. Previous recommendations have soared +143.0%, +175.9%, +498.3% and +673.0%. Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.Today, See These 5 Potential Home Runs >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Pfizer Inc. (PFE): Free Stock Analysis Report Alkermes plc (ALKS): Free Stock Analysis Report Vir Biotechnology, Inc. (VIR): Free Stock Analysis Report Nuvation Bio Inc. (NUVB): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksJan 21st, 2022

Amgen"s (AMGN) KRAS Inhibitor Gets Nod in Japan for Lung Cancer

Amgen's (AMGN) KRAS inhibitor, Lumakras, gets approval in Japan for the treatment of KRAS G12C-mutated positive advanced/recurrent non-small-cell lung cancer. Amgen Inc. AMGN announced that the Japan Ministry of Health, Labour and Welfare has approved its KRAS inhibitor, Lumakras (sotorasib). The drug is now approved in Japan for the treatment of KRAS G12C-mutated positive unresectable, advanced/recurrent non-small-cell lung cancer (“NSCLC”) in patients whose disease has progressed following systemic anti-cancer therapy.Lumakras is the only KRAS G12C inhibitor to be approved across the world.The approval in Japan was based on data from phase II CodeBreaK 100 study that evaluated Lumakras for NSCLC in patients with the KRAS G12C mutation. Data from the same showed that treatment with once-daily Lumakras (960 mg) led to an objective response rate of 37% in the given patient population.Shares of Amgen have decreased 9.7% in the past year compared with the industry’s decline of 37.9%.Image Source: Zacks Investment ResearchEarlier this month, the European Commission granted conditional marketing authorization to Lumykras.Lumykras is marketed under the trade name Lumakras in the United States.The FDA approved Lumakras in May 2021. The approval was on an accelerated basis, with continued approval contingent on verification of data from another study to confirm the drug’s benefits. The launch of Lumakras, a first-in-class lung cancer treatment, is off to an excellent start while its label expansion studies are progressing rapidly. Lumakras generated sales worth $36 million in the third quarter of 2021.Tumors characterized by KRAS, a common cancer mutation, are commonly associated with poor prognosis and resistance to therapy.Amgen is exploring more than 10 sotorasib combination regimens. The company is conducting a phase II monotherapy study on sotorasib in second-line NSCLC as well as in advanced colorectal cancer (“CRC”) patients. A phase II monotherapy study in patients with KRAS G12C-mutated solid tumors, other than those suffering from NSCLC and CRC, is ongoing. A phase II study in first-line NSCLC (in patients who are either PD-L1 negative or carrying STK11 mutations) was initiated in the third quarter of 2021. A phase III study on Lumakras + Vectibix in third-line CRC is expected to begin enrollment shortly. Amgen is also conducting phase Ib combination studies with PD-1, MEK, EGFR and other targeted therapies, with some initial data expected in first half of 2022.We note that many companies have KRAS G12C inhibitors in their pipelines being developed for various cancer indications. Mirati Therapeutics MRTX is developing adagrasib, a KRAS G12C inhibitor, both as a monotherapy and in combination studies for treating patients with KRAS G12C-positive tumors.In November 2021, Mirati initiated the submission of the new drug application for adagrasib to treat patients with previously treated KRAS G12C-mutated NSCLC.Mirati is also developing adagrasib for other cancer indications.Zacks Rank & Stocks to ConsiderAmgen currently carries a Zacks Rank #3 (Hold). Top-ranked stocks in the biotech sector include Dynavax Technologies Corporation DVAX and AnaptysBio, Inc. ANAB, both sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.Dynavax Technologies’ earnings estimates have been revised 18% upward for 2022 over the past 60 days.The stock has skyrocketed 152% in the past yearDynavax Technologies’ earnings have surpassed estimates in each of the trailing four quarters.AnaptysBio’s loss per share estimates have narrowed 0.3% for 2022, over the past 60 days. The stock has rallied 21.8% in the past year.AnaptysBio’s earnings surpassed estimates in three of the trailing four quarters and missed the same on the other occasion. 5 Stocks Set to Double Each was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2021. Previous recommendations have soared +143.0%, +175.9%, +498.3% and +673.0%. Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.Today, See These 5 Potential Home Runs >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Dynavax Technologies Corporation (DVAX): Free Stock Analysis Report Amgen Inc. (AMGN): Free Stock Analysis Report Mirati Therapeutics, Inc. (MRTX): Free Stock Analysis Report AnaptysBio, Inc. (ANAB): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksJan 21st, 2022

BridgeBio (BBIO), Amgen Partner in Advanced Solid Tumors Study

BridgeBio (BBIO) forges an alliance with Amgen to evaluate their respective cancer drugs for the treatment of advanced solid tumors with KRAS G12C mutations. BridgeBio Pharma, Inc. BBIO announced that it has entered into a non-exclusive clinical collaboration agreement with Amgen AMGN to evaluate the combination of its investigational SHP2 inhibitor BBP-398 with the latter’s KRAS G12C inhibitor Lumakras in patients with KRAS G12C-mutated advanced solid tumors.Both BridgeBio and Amgen will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of the combination in a phase I/II study. The study will first determine dose escalation for the combination followed by dose expansion and optimization.Per the agreement terms, BridgeBio will be responsible for sponsoring the study while Amgen is responsible for the worldwide supply of Lumakras.Per management estimates, KRAS mutations account for approximately 17% of malignant tumors. BridgeBio believes that the combination of an SHP2 inhibitor with a KRAS G12C inhibitor has the potential to prevent oncogenesis. BridgeBio also plans to enter into similar collaborations with other entities to explore such combinations.Shares of BridgeBio have plunged 81.4% in the trailing 12 months compared with the industry’s 31.4% decline.Image Source: Zacks Investment ResearchBridgeBio is currently evaluating BBP-398 in a phase I study in solid tumor patients. BBIO is also evaluating BBP-398 as a monotherapy or in combination with other therapies to target patients having KRAS G12C mutations.Lumakras is an FDA approved therapy approved since May 2021 for advanced non-small cell lung cancer (NSCLC). The launch of Lumakras in the United States is off to an excellent start, while its label expansion studies are progressing rapidly. Amgen generated $36 million from Lumakras’ sales in third-quarter 2021.Another company that has a KRAS inhibitor in its pipeline is Mirati Therapeutics MRTX. Adagrasib, Mirati’s leading KRAS inhibitor candidate, is being studied both as a monotherapy and in combination in a phase I/II study (KRYSTAL) to treat patients with KRAS G12C-positive tumors.Last October, Mirati entered into a non-exclusive clinical collaboration agreement with Sanofi SNY. The collaboration will evaluate the combination of Mirati’s KRASG12C inhibitor adagrasib with Sanofi's investigational SHP2 inhibitor SAR442720 (also known as RMC-4630) in a phase I/II dose escalation and expansion study in previously treated NSCLC patients with KRAS G12C mutations.Per the agreement terms, Mirati and Sanofi will jointly oversee and share costs of the above study. However, Sanofi will be responsible for sponsoring and operating the study.BridgeBio Pharma, Inc. Price BridgeBio Pharma, Inc. price | BridgeBio Pharma, Inc. QuoteZacks RankBridgeBio carries a Zacks Rank #3 (Hold) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Infrastructure Stock Boom to Sweep America A massive push to rebuild the crumbling U.S. infrastructure will soon be underway. It’s bipartisan, urgent, and inevitable. Trillions will be spent. Fortunes will be made. The only question is “Will you get into the right stocks early when their growth potential is greatest?” Zacks has released a Special Report to help you do just that, and today it’s free. Discover 5 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.Download FREE: How to Profit from Trillions on Spending for Infrastructure >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Sanofi (SNY): Free Stock Analysis Report Amgen Inc. (AMGN): Free Stock Analysis Report Mirati Therapeutics, Inc. (MRTX): Free Stock Analysis Report BridgeBio Pharma, Inc. (BBIO): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksJan 14th, 2022

Tesla Will Recouple With Reality When The Bulls Least Expect It

Stanphyl Capital’s commentary for the month ended December 31, 2021, discussing their short position in Tesla Inc (NASDAQ:TSLA). Q3 2021 hedge fund letters, conferences and more Tesla’s Absurd Diluted Market Cap We remain short the biggest bubble in modern stock market history, Tesla Inc. (TSLA), which has a completely absurd diluted market cap of almost […] Stanphyl Capital’s commentary for the month ended December 31, 2021, discussing their short position in Tesla Inc (NASDAQ:TSLA). if (typeof jQuery == 'undefined') { document.write(''); } .first{clear:both;margin-left:0}.one-third{width:31.034482758621%;float:left;margin-left:3.448275862069%}.two-thirds{width:65.51724137931%;float:left}form.ebook-styles .af-element input{border:0;border-radius:0;padding:8px}form.ebook-styles .af-element{width:220px;float:left}form.ebook-styles .af-element.buttonContainer{width:115px;float:left;margin-left: 6px;}form.ebook-styles .af-element.buttonContainer input.submit{width:115px;padding:10px 6px 8px;text-transform:uppercase;border-radius:0;border:0;font-size:15px}form.ebook-styles .af-body.af-standards input.submit{width:115px}form.ebook-styles .af-element.privacyPolicy{width:100%;font-size:12px;margin:10px auto 0}form.ebook-styles .af-element.privacyPolicy p{font-size:11px;margin-bottom:0}form.ebook-styles .af-body input.text{height:40px;padding:2px 10px !important} form.ebook-styles .error, form.ebook-styles #error { color:#d00; } form.ebook-styles .formfields h1, form.ebook-styles .formfields #mg-logo, form.ebook-styles .formfields #mg-footer { display: none; } form.ebook-styles .formfields { font-size: 12px; } form.ebook-styles .formfields p { margin: 4px 0; } Get Our Activist Investing Case Study! Get the entire 10-part series on our in-depth study on activist investing in PDF. Save it to your desktop, read it on your tablet, or print it out to read anywhere! Sign up below! (function($) {window.fnames = new Array(); window.ftypes = new Array();fnames[0]='EMAIL';ftypes[0]='email';}(jQuery));var $mcj = jQuery.noConflict(true); Q3 2021 hedge fund letters, conferences and more Tesla's Absurd Diluted Market Cap We remain short the biggest bubble in modern stock market history, Tesla Inc. (TSLA), which has a completely absurd diluted market cap of almost $1.2 trillion despite a steadily sliding share of the world’s EV market and a share of the overall auto market that’s only around 1.1% (yes, one POINT one percent). At some point when momentum-riding Tesla bulls (or, for that matter, bears) least expect it, TSLA will recouple with “reality,” and that’s why I continue to maintain a short position. So here’s “reality”… Tesla has no “moat” of any kind; i.e., nothing meaningfully proprietary in terms of electric car technology, while existing automakers—unlike Tesla­—have a decades-long “experience moat” of knowing how to mass-produce, distribute and service high-quality cars consistently and profitably. Excluding sunsetting emission credit sales Tesla is barely profitable. Growth in sequential unit demand for Tesla’s cars is at a crawl relative to expectations. Elon Musk is a pathological liar who under the terms of his SEC settlement cannot deny having committed securities fraud. Many Tesla bulls sincerely believe that ten years from now the company will be twice the size of Volkswagen or Toyota, thereby selling around 21 million cars a year (up from the current one million). To illustrate how utterly clueless this is, going from a million cars a year today to 21 million in ten years means Tesla would have to add a brand new 500,000 car/year factory with sold out production EVERY single quarter for ten years! To do this even in twenty years would require adding a new factory with sold out production every six months, at which point Tesla would then be approximately twice the size of Toyota (current market cap: $257 billion) or Volkswagen (current market cap: $130 billion), making a Tesla twenty times its current size worth perhaps $500 billion in twenty years. If you discount that $500 billion back by 15% a year (which is likely a much smaller return than any Tesla bull expects) for twenty years, you get a net present value for Tesla stock of approximately $30 a share, down over 97% from 2021’s closing price. That’s why when idiot Tesla bulls look at the company’s current large trailing percentage growth from its recent tiny base and extrapolate that into the future they’re being, well… idiot Tesla bulls! Q3 Deliveries In October Tesla reported Q3 deliveries of 241,000 cars, a 40,000-unit gain over Q2 that’s a rounding error for an auto company trading at even one-tenth of Tesla’s valuation. (For Q4 the gain is expected to be another 45-50,000.) If in any quarter GM or VW or Toyota sold 2.04 million vehicles instead of 2 million or 1.96 million, no one would pay the slightest bit of attention to the difference. Seeing as Tesla is now being valued at over fourteen GMs, it’s time (as noted above) to start looking at its relatively tiny numerical sequential sales growth, rather than Wall Street’s sell-side hype of “percentage off a small base.” In other words, if you want to be valued at a giant multiple of “the big boys,” you should be treated as a big boy. Perhaps the biggest reason Tesla has recently been able to post marginally increasing sequential quarterly deliveries is because competitors’ production (and thus inventories) are at the lowest level in decades due to the massive chip shortage, thereby eliminating a number of “Tesla alternatives.” Meanwhile, Tesla is enjoying record production because Musk (a notorious “corner-cutter”) is apparently willing to substitute untested, non-auto-grade chips for the more durable chips he can’t get; please see my Twitter post about this. A favorite hype story from Tesla bulls has been “the China market” and its “record” number of 73,659 Q3 deliveries there. Let’s put this in perspective: this was only around 4000 more cars than in Q1 and only around 11,000 more than in Q2—again, these are “growth” rounding errors. (Thanks to drastically slashed production from chip-starved competitors, look for around 30,000 more in Q4.) And that “record” Q3 China quarter gave it just 1.5% of the overall passenger vehicle market and just 11% of the BEV market, and it had so much excess capacity that it exported tens of thousands of cars to Europe. Remember when Musk claimed that Tesla’s Chinese domestic demand alone would need multiple factories to satisfy? Ah, the good old days! Meanwhile, Tesla remains a lousy business. In its Q3 earnings report the company claimed it made around $1.3 billion in free cash flow (defined as operating cash flow less capex). However, this number appears to be entirely due to working capital adjustments and not from the business itself. Let me explain: Tesla claimed operating cash flow of around $3.2 billion for the quarter, but this came with the benefit of accounts payable increasing by $702 million, receivables declining by $167 million and accrued liabilities up by $665 million while (detrimentally) prepaid expenses increased by $144 million. Adjusting for that massive net working capital benefit, operating cash flow was only a bit over $1.8 billion and with capex at $1.8 billion it means Tesla’s Q3 free cash flow was essentially zero, and if you deduct stock comp (a non-cash item paid through share dilution) it was around negative $500 million. Also in its Q3 report Tesla claimed it made around $1.45 billion in net income after excluding $279 million of pure-profit emission credit sales (excluded because they’ll almost entirely disappear some time next year when other automakers will have enough EVs of their own), and after adding back a $50 million Bitcoin write-down. However, that earnings number also includes what I estimate to be Tesla’s usual $300 million or so in unsustainably low warranty provisioning, and after adjusting for that and assuming no other fraudulent accounting, Tesla only earned around $1.06/share, which annualizes to $4.24. An auto industry PE multiple of 10x would thus make TSLA worth around $42/share (admittedly, more than the “$0” I once expected), while a “growth multiple” of 20x would value it at $84, which is a 92% discount to December’s closing price of around $1057. And before you tell me that a 100% premium to the industry’s PE ratio isn’t enough, keep in mind that—as noted earlier—Tesla’s sequential unit growth is an auto industry rounding error. In fact, one could argue that Tesla’s multiple should carry a discount, considering the massive legal and financial liabilities continually generated by its pathologically lying CEO. Full Self Driving Meanwhile Tesla continues to sell (and book cash flow, if not accounting revenue from) its fraudulent & dangerous so-called “Full Self Driving.” In a sane regulatory environment Tesla having done this for five years now… …would be considered “consumer fraud,” and indeed the regulatory tide may finally be turning, as in August two U.S. Senators demanded an FTC investigation and in October the NHTSA appointed a harsh critic of this deadly product to advise on its regulation. (For all known Tesla deaths see here.) Are major write-downs and refunds on the way, killing the company’s slight “claimed profitability”? Stay tuned! Meanwhile, Guidehouse Insights continues to rate Tesla dead last among autonomous competitors: Another favorite Tesla hype story has been built around so-called “proprietary battery technology.” In fact though, Tesla has nothing proprietary there—it doesn’t make them, it buys them from Panasonic, CATL and LG, and it’s the biggest liar in the industry regarding the real-world range of its cars. And if new-format 4680 cells enter the market some time in 2022 (as is now expected), even if Tesla makes some of its own, other manufacturers will gladly sell them to anyone. Tesla Build Quality Remains Awful Meanwhile, Tesla build quality remains awful (it ranks second-to-last in the latest Consumer Reports reliability survey and in the bottom 10% of the latest J.D. Power survey) and its worst-rated Model Y faces current (or imminent) competition from the much better built electric Audi Q4 e-tron, BMW iX3, Mercedes EQB, Volvo XC40 Recharge, Volkswagen ID.4, Ford Mustang Mach E, Nissan Ariya, Hyundai Ioniq 5 and Kia EV6. And Tesla’s Model 3 now has terrific direct “sedan competition” from Volvo’s beautiful Polestar 2, the great new BMW i4 and the premium version of Volkswagen’s ID.3 (in Europe), plus multiple local competitors in China. And in the high-end electric car segment worldwide the Audi e-tron (substantially improved for 2022!) and Porsche Taycan outsell the Models S & X (and the newly updated Tesla models with their dated exteriors and idiotic shifters & steering wheels won’t change this), while the spectacular new Mercedes EQS, Audi e-Tron GT and Lucid Air make the Tesla Model S look like a fast Yugo, while the extremely well reviewed new BMW iX does the same to the Model X. And oh, the joke of a “pickup truck” Tesla previewed in 2019 (and still hasn’t shown in production-ready form) won’t be much of “growth engine” either, as it will enter a dogfight of a market; in fact, Ford’s terrific 2022 all-electric F-150 Lightning now has nearly 200,000 retail reservations (plus many more fleet reservations), Rivian’s pick-up has gotten fantastic early reviews, and in January GM will introduce its electric Silverado. Regarding safety, as noted earlier in this letter, Tesla continues to deceptively sell its hugely dangerous so-called “Autopilot” system, which Consumer Reports has completely eviscerated; God only knows how many more people this monstrosity unleashed on public roads will kill despite the NTSB condemning it. Elsewhere in safety, in 2020 the Chinese government forced the recall of tens of thousands of Teslas for a dangerous suspension defect the company spent years trying to cover up, and now Tesla has been hit by a class-action lawsuit in the U.S. for the same defect. Tesla also knowingly sold cars that it knew were a fire hazard and did the same with solar systems, and after initially refusing to do so voluntarily, it was forced to recall a dangerously defective touchscreen. In other words, when it comes to the safety of customers and innocent bystanders, Tesla is truly one of the most vile companies on Earth. Meanwhile the massive number of lawsuits of all types against the company continues to escalate. So Here Is Tesla's Competition In Cars (Note: These Links Are Regularly Updated)... Porsche Taycan Porsche Taycan Cross Turismo Porsche Macan Electric SUV Officially Coming in 2023 Volkswagen ID.3 Headlines VW's Electrified Future Volkswagen ID.4 Electric SUV Volkswagen ID.Buzz electric van teased ahead of 2022 launch Volkswagen ID 6 to arrive with 435-mile range in 2023 Volkswagen Aero B: new electric Passat equivalent spied VW’s Cupra brand counts on performance for Born EV Cupra, VW brand to get entry-level battery-powered cars Audi e-tron Audi e-tron Sportback Audi E-tron GT Audi Q4 e-tron Audi Q6 e-tron confirmed for 2022 launch Audi previews long-range A6 e-tron EV Audi TT set to morph into all-electric crossover Hyundai Ioniq 5 Hyundai Ioniq 6 spotted ahead of 2022 launch Hyundai Kona Electric Genesis reveals their first EV on the E-GMP platform, the electric GV60 crossover Genesis Electrified GV70 Revealed With 483 Horsepower And AWD Kia Niro Electric: 239-mile range & $39,000 before subsidies Kia EV6: Charging towards the future Kia EV4 on course to grow electric SUV range Jaguar’s All-Electric i-Pace Jaguar to become all-electric brand; Land Rover to Get 6 electric models Daimler will invest more than $47B in EVs and be all-electric ready by 2030 Mercedes EQS: the first electric vehicle in the luxury class Mercedes EQS SUV takes shape Mercedes-Benz unveils EQE electric sedan with impressive 400-mile range Mercedes EQE SUV to rival BMW iX and Tesla Model X Mercedes EQC electric SUV available now in Europe & China Mercedes-Benz Launches the EQV, its First Fully-Electric Passenger Van Mercedes-Benz EQB Makes Its European Debut, US Sales Confirmed Mercedes-Benz unveils EQA electric SUV with 265 miles of range and ~$46,000 price Ford Mustang Mach-E Available Now Ford F-150 Lightning electric pick-up available 2022 Ford set to launch ‘mini Mustang Mach-E’ electric SUV in 2023 Ford to offer EV versions of Explorer, Aviator, ‘rugged SUVs' Volvo Polestar 2 Polestar 3 SUV Production Design Revealed. The US-built electric SUV will debut in 2022. Volvo XC40 Recharge Volvo C40 electric sedan to challenge Tesla Model 3, VW ID3 Polestar 3 will be an electric SUV that shares its all-new platform with next Volvo XC90 Chevy updates, expands Bolt EV family as price drops Cadillac All-Electric Lyriq Available Spring 2022 GMC ALL-ELECTRIC SUPERTRUCK HUMMER EV GM to build electric Silverado in Detroit with estimated range of more than 400 miles GMC to launch electric Hummer SUV in 2023 GM will offer 30 all-electric models globally by 2025 GM Launches BrightDrop to Electrify the Delivery of Goods and Services Nissan vows to hop back on EV podium with Ariya Nissan LEAF e+ with 226-mile range is available now Nissan Unveils $18 Billion Electric-Vehicle Strategy BMW leads off EV offensive with iX3 BMW expands EV offerings with iX tech flagship and i4 sedan BMW i7 Confirmed for 2022 Launch 2022 BMW iX1 electric SUV spied Rivian R1T Is the Most Remarkable Pickup We’ve Ever Driven Renault upgrades Zoe electric car as competition intensifies Renault Dacia Spring Electric SUV Renault to boost low-volume Alpine brand with 3 EVs Renault's electric Megane will debut new digital cockpit Stellantis promises 'heart-of-the-market SUV' from new, 8-vehicle EV platform Alfa Romeo is latest Stellantis brand to get all-electric future Peugeot e-208 PEUGEOT E-2008: THE ELECTRIC AND VERSATILE SUV Peugeot 308 will get full-electric version Subaru shows off its first electric vehicle, the Solterra SUV Citroen compact EV challenges VW ID3 on price Maserati to launch electric sports car Mini Cooper SE Electric Toyota’s Electric bZ4X Goes On Sale in Spring 2022 Toyota will have lineup of 30 full EVs by 2030; Lexus will be all-electric brand Opel sees electric Corsa as key EV entry 2021 Vauxhall Mokka revealed as EV with sharp looks, massive changes Skoda Enyaq iV electric SUV offers range of power, battery sizes Electric Skoda Enyaq coupe to muscle-in on Tesla Model 3 Skoda plans small EV, cheaper variants to take on French, Korean rivals Nio to launch in five more European countries after Norway BYD will launch electric SUV in Europe The Lucid Air Achieves an Estimated EPA Range of 517 Miles on a Single Charge Bentley converting to electric-only brand All-electric Rolls-Royce Spectre to launch in 2023 – firm to be EV-only by 2030 Aston Martin will build electric vehicles in UK from 2025 Meet the Canoo, a Subscription-Only EV Pod Coming in 2021 Two new electric cars from Mahindra in India; Global Tesla rival e-car soon Former Saab factory gets new life building solar-powered Sono Sion electric cars Foxconn aims for 10% of electric car platform market by 2025 And In China... How VW Group plans to dominate China's EV market VW Goes Head-to-Head With Tesla in China With New ID.4 Crozz Electric SUV Volkswagen’s ID.3 EV to be produced by JVs with SAIC, FAW in 2021 2022 VW ID.6 Revealed With Room For Seven And Two Electric Motors China-built Audi e-tron rolls off production line in Changchun Audi Q2L e-tron debuts at Auto Shanghai Audi will build Q4 e-tron in China Audi Q5 e-tron Confirmed For China Audi in cooperation company for local electric car production with FAW FAW Hongqi starts selling electric SUV with 400km range for $32,000 FAW (Hongqi) to roll out 15 electric models by 2025 BYD goes after market left open by Tesla with four cheaper models for budget-conscious buyers BYD said to launch premium NEV brand ‘Dolphin’ in 2022 Top of Form Bottom of Form Daimler & BYD launch DENZA electric vehicle for the Chinese market Geely announces premium EV brand Zeekr Geely, Mercedes-Benz launch $780 million JV to make electric smart-branded cars Mercedes styled Denza X 7-seat electric SUV to hit market Mercedes ‘makes mark’ with China-built EQC BMW, Great Wall to build new China plant for electric cars BAIC Goes Electric, & Establishes Itself as a Force in China’s New Energy Vehicle Future BAIC BJEV, Magna ready to pour RMB2 bln in all-electric PV manufacturing JV Toyota partners with BYD to build affordable $30,000 electric car Ford MUSTANG MACH-E ROLLS OFF ASSEMBLY LINE IN CHINA FOR LOCAL CUSTOMERS Lexus to launch EV in China taking on VW and Tesla GAC Aion about to start volume production of 1,000-km range AION LX GAC Toyota to ramp up annual capacity by 400,000 NEVs GAC kicks off delivery of HYCAN 007 all-electric SUV Nio – Ready For Tomorrow Nio steps up plans for mass-market brand to compete with VW, Toyota Xpeng Motors sells multiple EV models SAIC-GM to build Ultium EV platform in Wuhan Chevrolet Menlo Electric Vehicle Launched in China Buick Introduces New VELITE 6 EV with Extended Range Buick Velite 7 EV And Velite 6 PHEV Launch In China Dongfeng launches the all-electric Voyah  PSA to accelerate rollout of electrified vehicles in China SAIC, Alibaba-backed EV brand IM begins presale of first model L7 Hyundai Motor Transforming Chongqing Factory into Electric Vehicle Plant Polestar said to plan China showroom expansion to compete with Tesla Jaguar Land Rover's Chinese arm invests £800m in EV production Renault reveals series urban e-SUV K-ZE for China Renault & Brilliance detail electric van lineup for China Renault forms China electric vehicle venture with JMCG Honda to start sales of new EV-branded vehicles in China in 2022 Geely launches new electric car brand 'Geometry' – will launch 10 EVs by 2025 Geely, Foxconn form partnership to build cars for other automakers Fiat Chrysler, Foxconn Team Up for Electric Vehicles Baidu to create an intelligent EV company with automaker Geely Leapmotor starts presale of C11 electric SUV on Jan. 1 2021 Changan forms subsidiary Avatar Technology to develop smart EVs with Huawei, CATL WM Motors/Weltmeister Chery Seres Enovate China's cute Ora R1 electric hatch offers a huge range for less than US$9,000 Singulato JAC Motors releases new product planning, including many NEVs Seat to make purely electric cars with JAC VW in China Iconiq Motors Hozon Aiways Skyworth Auto Youxia CHJ Automotive begins to accept orders of Leading Ideal ONE Infiniti to launch Chinese-built EV in 2022 Human Horizons Chinese smartphone giant Xiaomi to launch electric car business with $10 billion investment Lifan Technology to roll out three EV models with swappable batteries in 2021 Here’s Tesla’s Competition In Autonomous Driving... Waymo ranked top & Tesla last in Guidehouse leaderboard on automated driving systems Tesla has a self-driving strategy other companies abandoned years ago Fiat Chrysler, Waymo expand self-driving partnership for passenger, delivery vehicles Waymo and Lyft partner to scale self-driving robotaxi service in Phoenix Volvo, Waymo partner to build self-driving vehicles Jaguar and Waymo announce an electric, fully autonomous car Renault, Nissan partner with Waymo for self-driving vehicles Geely’s Zeekr, Waymo partner on autonomous ride-hailing vehicle for the U.S. market Cruise and GM Team Up with Microsoft to Commercialize Self-Driving Vehicles Cadillac Super Cruise Sets the Standard for Hands-Free Highway Driving Honda Joins with Cruise and General Motors to Build New Autonomous Vehicle Honda launching Level 3 autonomous cars Volkswagen moves ahead with Autonomous Driving R&D for Mobility as a Service Volkswagen teams up with Microsoft to accelerate the development of automated driving VW taps Baidu's Apollo platform to develop self-driving cars in China Ford “Blue Cruise” ARGO AI AND FORD TO LAUNCH SELF-DRIVING VEHICLES ON LYFT NETWORK Hyundai and Kia Invest in Aurora Toyota, Denso form robotaxi partnership with Aurora Aptiv and Hyundai Motor Group complete formation of autonomous driving joint venture Amazon’s Zoox unveils electric robotaxi that can travel up to 75 mph Nvidia and Mercedes Team Up to Make Next-Gen Vehicles Daimler's heavy trucks start self-driving some of the way SoftBank, Toyota's self-driving car venture adds Mazda, Suzuki, Subaru Corp, Isuzu Daihatsu  Continental & NVIDIA Partner to Enable Production of Artificial Intelligence Self-Driving Cars Mobileye and Geely to Offer Most Robust Driver Assistance Features Mobileye Starts Testing Self-Driving Vehicles in Germany Mobileye and NIO Partner to Bring Level 4 Autonomous Vehicles to Consumers Lucid Chooses Mobileye as Partner for Autonomous Vehicle Technology Alibaba-backed AutoX unveils first driverless RoboTaxi production line in China Nissan gives Japan version of Infiniti Q50 hands-free highway driving Hyundai to start autonomous ride-sharing service in Calif. Pony.ai Receives Approval for Paid Autonomous Robotaxi Services in Beijing Baidu kicks off its robotaxi business, after getting the OK to charge fees in Beijing Toyota to join Baidu's open-source self-driving platform Baidu, WM Motor announce strategic partnership for L3, L4 autonomous driving solutions Volvo will provide cars for Didi's self-driving test fleet BMW and Tencent to develop self-driving car technology together BMW, NavInfo bolster partnership in HD map service for autonomous cars in China GM Invests $300 M in Momenta to deliver self-driving technologies in China FAW Hongqi readies electric SUV offering Level 4 autonomous driving Tencent, Changan Auto Announce Autonomous-Vehicle Joint Venture Huawei teams up with BAIC BJEV, Changan, GAC to co-launch self-driving car brands GAC Aion, DiDi Autonomous Driving to co-develop driverless NEV model BYD partners with Huawei for autonomous driving Lyft, Magna in Deal to Develop Hardware, Software for Self-Driving Cars Xpeng releases autonomous features for highway driving Nuro Becomes First Driverless Car Delivery Service in California Deutsche Post to Deploy Test Fleet Of Fully Autonomous Delivery Trucks ZF autonomous EV venture names first customer Magna’s new MAX4 self-driving platform offers autonomy up to Level 4 Groupe PSA’s safe and intuitive autonomous car tested by the general public Mitsubishi Electric to Exhibit Autonomous-driving Technologies in New xAUTO Test Vehicle Apple acquires self-driving startup Drive.ai Motional to begin robotaxi testing with Hyundai Ioniq 5 in Los Angeles JD.com Delivers on Self-Driving Electric Trucks NAVYA Unveils First Fully Autonomous Taxi Fujitsu and HERE to partner on advanced mobility services and autonomous driving Great Wall’s autonomous driving arm Haomo.ai receives investment from Meituan Plus.ai, Iveco to start L4 autonomous heavy-duty truck test in Europe, China T3 Mobility, IDRIVERPLUS to pilot Robotaxi operation in Suzhou with autonomous+manual model Here’s Where Tesla’s Competition Will Get Its Battery Cells... Panasonic (making deals with multiple automakers) LG Samsung SK Innovation Toshiba CATL BYD Volkswagen to Build Six Electric-Vehicle Battery Factories in Europe How GM's Ultium Battery Will Help It Commit to an Electric Future GM to develop lithium-metal batteries with SolidEnergy Systems Ford, SK Innovation announce EV battery joint venture BMW & Ford Invest in Solid Power to Secure All Solid-State Batteries for Future Electric Vehicles Stellantis, LG Energy Solution to form battery JV for N. American market Stellantis and Factorial Energy to Jointly Develop Solid-State Batteries for Electric Vehicles Toyota to build plant in N.C. capable of making up to 1.2M batteries a year Toyota Outlines Solid-State Battery Tech, $13.6 Billion Investment Nissan Announces Proprietary Solid-State Batteries Daimler joins Stellantis as partner in European battery cell venture ACC Renault signs EV battery deals with Envision, Verkor for French plants Nissan to build $1.4bn EV battery plant in UK with Chinese partner UK companies AMTE Power and Britishvolt plan $4.9 billion investment in battery plants Freyr Verkor Farasis Microvast Akasol Cenat Wanxiang Eve Energy Svolt Romeo Power ProLogium Hyundai Motor developing solid-state EV batteries Daimler Morrow Here’s Tesla’s Competition In Charging Networks... Infrastructure Bill: $7.5 billion Towards Nationwide Network of 500,000 EV Chargers Electrify America is spending $2 billion building a high-speed U.S. charging network 51 U.S. electric companies commit to build nationwide EV fast charging network by end of 2023 GM to distribute up to 10 chargers to each of its dealerships starting early 2022 General Motors and EVgo Boost Build Plan for High Power Fast Chargers Across the US Circle K Owner Plans Electric-Car Charging Push in U.S., Canada 191 U.S. Porsche dealers are installing 350kw chargers ChargePoint to equip Daimler dealers with electric car chargers GM and Bechtel plan to build thousands of electric car charging stations across the US Ford introduces 12,000 station charging network, teams with Amazon on home installation Shell Plans To Deploy Around 500,000 Charging Points Globally By 2025 Petro-Canada Introduces Coast-to-Coast Canadian Charging Network Volta is rolling out a free charging network Ionity Europe E.ON and Virta launch one of the largest intelligent EV charging networks in Europe Volkswagen plans 36,000 charging points for electric cars throughout Europe Smatric has over 400 charging points in Austria Allego has hundreds of chargers in Europe PodPoint UK charging stations BP Chargemaster/Polar is building stations across the UK Instavolt is rolling out a UK charging network Fastned building 150kw-350kw chargers in Europe Aral To Install Over 100 Ultra-Fast Chargers In Germany Deutsche Telekom launches installation of charging network for e-cars Total to build 1,000 high-powered charging points at 300 European service-stations NIO teams up with China’s State Grid to build battery charging, swapping stations Volkswagen-based CAMS launches supercharging stations in China Volkswagen, FAW Group, JAC Motors, Star Charge formally announce new EV charging JV BMW to Build 360,000 Charging Points in China to Juice Electric Car Sales BP, Didi Jump on Electric-Vehicle Charging Bandwagon Evie rolls out ultrafast charging network in Australia Evie Networks To Install 42 Ultra-Fast Charging Sites In Australia And Here’s Tesla’s Competition In Storage Batteries... Panasonic Samsung LG BYD AES + Siemens (Fluence) GE Bosch Hitachi ABB Toshiba Saft Johnson Contols EnerSys SOLARWATT Schneider Electric Sonnen Kyocera Generac Kokam NantEnergy Eaton Nissan Tesvolt Kreisel Leclanche Lockheed Martin EOS Energy Storage ESS UET electrIQ Power Belectric Stem ENGIE Redflow Renault Primus Power Simpliphi Power redT Energy Storage Murata Bluestorage Adara Blue Planet Tabuchi Electric Aggreko Orison Moixa Powin Energy Nidec Powervault Kore Power Shanghai Electric Schmid 24M Ecoult Innolith LithiumWerks Natron Energy Energy Vault Ambri Voltstorage Cadenza Innovation Morrow Gridtential Villara Elestor Thanks and Happy New Year, Mark Spiegel Updated on Jan 3, 2022, 11:25 am (function() { var sc = document.createElement("script"); sc.type = "text/javascript"; sc.async = true;sc.src = "//mixi.media/data/js/95481.js"; sc.charset = "utf-8";var s = document.getElementsByTagName("script")[0]; s.parentNode.insertBefore(sc, s); }()); window._F20 = window._F20 || []; _F20.push({container: 'F20WidgetContainer', placement: '', count: 3}); _F20.push({finish: true});.....»»

Category: blogSource: valuewalkJan 3rd, 2022

Blueprint Medicines (BPMC) Up 24.8% in Past 6 Months: Here"s Why

Blueprint Medicines' (BPMC) Ayvakit, approved to treat PDGFRA Exon 18 mutant gastrointestinal stromal tumors, has seen strong uptake since approval. Other pipeline candidates are also progressing well. Shares of Blueprint Medicines Corporation BPMC have rallied 24.8% in the past six months against the industry’s decrease of 18.7%.Image Source: Zacks Investment ResearchThe company has made steady progress with its lead drug, Ayvakit (avapritinib), approved by the FDA for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors (“GIST”), harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations, in this time frame. The European Commission has granted conditional marketing authorization to Ayvakyt as a monotherapy for the treatment of adult patients with unresectable/metastatic GIST, harboring the PDGFRA D842V mutation.Ayvakit/Ayvakyt has witnessed strong uptake since its launch.In June 2021, the FDA approved Ayvakit for a new indication – advanced systemic mastocytosis (“SM”), a rare and debilitating disease. Ayvakit is being evaluated in the phase II PIONEER study for treating non-advanced SM.Blueprint Medicines is co-developing another cancer drug, Gavreto (pralsetinib), with Roche RHHBY for treating patients with various types of RET-altered thyroid cancers and other solid tumors.In July 2021, Blueprint Medicines transferred the responsibilities of booking U.S. product sales of Gavreto to Roche. The company only records the share of profit and loss for Gavreto in financial results and does not record any net product revenues from Gavreto sales.The FDA approved Gavreto for treating advanced/metastatic RET-mutant and RET fusion-positive thyroid cancer, in December 2020. Gavreto is also approved for the treatment of adults with metastatic RET fusion-positive non-small-cell lung cancer.This apart, Blueprint Medicines has other promising pipeline candidates that are progressing well, targeting various cancer indications.In December 2021, Blueprint Medicines closed the previously announced acquisition of privately held biopharmaceutical company, Lengo Therapeutics. The acquisition will expand Blueprint Medicines’ precision oncology therapies and transform treatment for patients with EGFR-driven lung cancer. The acquisition added Lengo Therapeutics’ lead compound, LNG-451, to Blueprint Medicines’ portfolio.LNG-451, a potential best-in-class oral precision therapy, is currently being developed for the treatment of non-small cell lung cancer in patients with EGFR exon 20 insertion mutations.Blueprint Medicines’ current product revenues solely comprise sales from Ayvakit, which narrows its revenues stream. Hence, any regulatory setback for the drug could hurt the stock in the days ahead.Also, Ayvakit faces competition from Deciphera Pharmaceuticals' DCPH Qinlock (ripretinib), which is approved for the treatment of fourth-line GIST. In November 2021, the European Commission approved Qinlock for the same indication.Deciphera is looking to streamline commercial operations for Qinlock in the United States and focus on commercialization efforts on a select number of key European markets for the medicine.Blueprint Medicines Corporation Price Blueprint Medicines Corporation price | Blueprint Medicines Corporation QuoteZacks Rank & Stock to ConsiderBlueprint Medicines currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Sarepta Therapeutics, Inc. SRPT, which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.Sarepta Therapeutics’ loss per share estimates have narrowed 28.2% for 2021 and 25.2% for 2022, over the past 60 days.Earnings of Sarepta Therapeutics have surpassed estimates in two of the trailing four quarters, and missed the same on the other two occasions. Infrastructure Stock Boom to Sweep America A massive push to rebuild the crumbling U.S. infrastructure will soon be underway. It’s bipartisan, urgent, and inevitable. Trillions will be spent. Fortunes will be made. The only question is “Will you get into the right stocks early when their growth potential is greatest?” Zacks has released a Special Report to help you do just that, and today it’s free. Discover 7 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.Download FREE: How to Profit from Trillions on Spending for Infrastructure >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Roche Holding AG (RHHBY): Free Stock Analysis Report Sarepta Therapeutics, Inc. (SRPT): Free Stock Analysis Report Blueprint Medicines Corporation (BPMC): Free Stock Analysis Report Deciphera Pharmaceuticals, Inc. (DCPH): Free Stock Analysis Report To read this article on Zacks.com click here......»»

Category: topSource: zacksJan 2nd, 2022

Sanofi (SNY) to Acquire Amunix, Boost Immuno-oncology Pipeline

Sanofi (SNY) inks a deal to acquire privately-held Amunix Pharmaceuticals, which will add potentially transformative cancer therapies to its immuno-oncology pipeline. Sanofi SNY announced that it has entered into an agreement to acquire privately-held, immuno-oncology company, Amunix Pharmaceuticals, for an upfront payment of approximately $1 billion.The acquisition of Amunix will add potentially transformative cancer therapies and three technology platforms to Sanofi’s pipeline.Amunix’s proprietary masking technology platform, XTEN, will help Sanofi develop safer and more efficacious cancer drugs by activating preferentially in disease-specific micro-environments. The platform has the potential to discover T-Cell Engager bi-specific antibodies for solid tumors without the risk of unwanted immune attack including cytokine release syndrome. The masking technology also enables the development of drugs that can stay in the patient’s body for a long time in inactive mode but is rapidly cleared from the body as it reaches disease-specific cells. Amunix’s masking technology can be applied to discover new drug molecules as well as to Sanofi’s existing pipeline candidates.Amunix has no clinical-stage candidate in its pipeline. Its lead pipeline candidate, AMX-818 — developed using the XTEN platform — is being developed for targeting HER2-expressing solid tumors. The candidate is likely to enter clinical study shortly.Sanofi already has approximately 20 innovative cancer therapies under development and the Amunix buyout is believed to boost its immuno-oncology pipeline.The acquisition is expected to be completed in the first quarter of 2021, subject to customary closing conditions. In addition to the upfront payment, Sanofi will also be entitled to pay up to $225 million in milestone payments to Amunix’s shareholders upon achievement of certain future development milestones.Sanofi’s shares have gained 0.9% so far this year compared with the industry’s increase of 19%.Image Source: Zacks Investment ResearchSanofi has significantly stepped up its acquisition and alliance activity over the past few years to boost its pipeline and portfolio of drugs.In September, Sanofi acquired its partner for some pipeline candidates, Translate Bio for approximately $3.2 billion. The acquisition added a promising mRNA technology platform to develop therapeutics and vaccines and also accelerate the development of their existing partnered pipeline programs. The company also acquired two clinical-stage biopharmaceutical companies, Kiadis and Kymab, in April. These acquisitions added natural-killer cell therapies, and immune and inflammatory candidates to its pipeline.Sanofi acquired another biopharma company, Kadmon Holdings, last month adding an FDA-approved treatment for chronic graft-versus-host disease, Rezurock, to its commercialized portfolio.Sanofi Price Sanofi price | Sanofi QuoteZacks Rank & Stocks to ConsiderSanofi currently carries a Zacks Rank #3 (Hold).Some better-ranked stocks from the pharma/biotech sector include GlaxoSmithKline GSK, Repligen RGEN and Sarepta Therapeutics SRPT. While Repligen sports a Zacks Rank #1 (Strong Buy), Glaxo and Sarepta carry a Zacks Rank of 2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.Earnings per share estimates for Glaxo have increased from $2.82 to $3.05 for 2021 and from $3.08 to $3.25 for 2022 in the past 60 days.Glaxo delivered an earnings surprise of 15.28%, on average, in the last four quarters. GSK’s shares are up 17% so far this year.Earnings per share estimates for Repligen have moved north from $2.76 to $2.90 for 2021 and from $3.03 to $3.21 for 2022 in the past 60 days.Repligen delivered an earnings surprise of 49.21%, on average, in the last four quarters. RGEN’s shares are up 40.7% so far this year.Estimates for 2021 have narrowed from a loss of $6.95 to $4.99 for Sarepta in the past 60 days. Estimates for Sarepta’s 2022 bottom line have changed from a loss per share of $4.78 to earnings per share of $3.61 in the past 60 days.Sarepta delivered an earnings surprise of 11.06%, on average, in the last four quarters.Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Sanofi (SNY): Free Stock Analysis Report GlaxoSmithKline plc (GSK): Free Stock Analysis Report Repligen Corporation (RGEN): Free Stock Analysis Report Sarepta Therapeutics, Inc. (SRPT): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksDec 21st, 2021

Seagen (SGEN) Gets Positive CHMP Opinion for Bladder Cancer Drug

The CHMP gives a positive opinion on, and recommends approval to Seagen's (SGEN) Padcev as a monotherapy for treating adult patients with locally advanced/metastatic urothelial cancer. Seagen Inc. SGEN and partner Astellas Pharma Inc. announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion on, and has recommended marketing authorization to its an antibody-drug conjugate ("ADC"), Padcev (enfortumab vedotin). The CHMP recommended approval of Padcev as a monotherapy for the treatment of locally advanced or metastatic urothelial cancer in adult patients who have previously received platinum-containing chemotherapy and a PD-1/L1 inhibitor.The positive CHMP opinion was based on data from the phase III EV-301 study, which evaluated enfortumab vedotin versus chemotherapy in the given patient population. The study had a primary endpoint of overall survival.The opinion will now be reviewed by the European Commission. If approved, Padcev will become the first ADC authorized for patients with advanced urothelial cancer in the European Union.Shares of Seagen have declined 14.3% so far this year compared with the industry’s decrease of 19%.Image Source: Zacks Investment ResearchWe remind investors that in December 2019, FDA granted accelerated approval to Padcev for the treatment of patients with advanced/metastatic urothelial cancer who had received treatment with both a checkpoint inhibitor (PD-1/PD-L1) and platinum-based chemotherapy.In July 2021, the FDA approved two supplemental biologics license applications (sBLA) seeking label expansion for Padcev.The first sBLA approval converts Padcev’s accelerated approval to regular approval in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. The second sBLA approval makes Padcev the first and only FDA-approved drug to treat patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and are not eligible for cisplatin.In the first nine months of 2021, Padcev generated sales worth $247.2 million, reflecting an increase of 61% year over year. The drug has witnessed a solid uptake since its launch. A potential label expansion of the drug is expected to cater to a broader market, which will boost its revenue prospects in the future.Seagen is also investigating Padcev in combination with Merck’s MRK PD-L1 inhibitor, Keytruda in several mid-stage studies in first- and second-line metastatic urothelial cancer, as well as muscle invasive bladder cancer.Merck’s biggest revenue generator, Keytruda, is approved for treating several types of cancer indications.The drug is also being studied for other types of cancer indication.Zacks Rank & Stocks to ConsiderSeagen currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Sarepta Therapeutics, Inc. SRPT and Editas Medicine, Inc. EDIT, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.Sarepta Therapeutics’ loss per share estimates have narrowed 28.2% for 2021 and 24.4% for 2022, over the past 60 days.Earnings of Sarepta Therapeutics have surpassed estimates in two of the trailing four quarters, and missed the same on the other two occasions.Editas Medicine’s loss per share estimates have narrowed 13.4% for 2021 and 6.6% for 2022, over the past 60 days.Editas Medicine’s earnings have surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions. 5 Stocks Set to Double Each was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2021. Previous recommendations have soared +143.0%, +175.9%, +498.3% and +673.0%. Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.Today, See These 5 Potential Home Runs >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Merck & Co., Inc. (MRK): Free Stock Analysis Report Sarepta Therapeutics, Inc. (SRPT): Free Stock Analysis Report Seagen Inc. (SGEN): Free Stock Analysis Report Editas Medicine, Inc. (EDIT): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksDec 20th, 2021

Exelixis (EXEL) Initiates Study on XL092 in Advanced Solid Tumors

Exelixis (EXEL) begins the dose-escalation stage of its study evaluating XL092 in combination with immuno-oncology therapies in patients with advanced solid tumors. Exelixis, Inc. EXEL recently announced that it has initiated the dose-escalation stage of its phase Ib study, STELLAR-002.STELLAR-002 is the second study to evaluate XL092 in advanced cancers.  The phase Ib study is evaluating XL092 in combination with immuno-oncology therapies in advanced solid tumors.  XL092 is a next-generation oral tyrosine kinase inhibitor (TKI) that targets kinases implicated in cancer growth and spread, including VEGF receptors, MET, AXL and MER. The study's objective is to evaluate the safety, tolerability and efficacy of XL092, in combination with Bristol Myers’ BMY Opdivo (nivolumab), Opdivo and Yervoy; and Opdivo and bempegaldesleukin.The dose-escalation stage will determine the recommended dose in patients with advanced solid tumors for each of the XL092 combination therapy regimens. The study will begin to enroll tumor-specific expansion cohorts for patients with advanced renal cell carcinoma (RCC), urothelial carcinoma and metastatic castration-resistant prostate cancer, once the recommended dose is established. The primary efficacy endpoint of the expansion stage will be objective response rates, except for the cohort of patients with metastatic castration-resistant prostate cancer. The primary endpoint will be the duration of radiographic progression-free survival.While Exelixis is sponsoring STELLAR-002, Bristol-Myers is providing Opdivo, Yervoy and bempegaldesleukin for use in the trial.  Both the companies had entered into a clinical trial collaboration and supply agreement in June.XL092 is the first internally discovered Exelixis compound to enter the clinic following the company’s reinitiation of drug-discovery activities.  It is currently being developed to treat advanced solid tumors, including genitourinary cancers, as a monotherapy and in combination with immune checkpoint inhibitors.Exelixis’ shares have lost 11% in the year so far compared with the industry’s decline of 20.3%.Image Source: Zacks Investment ResearchExelixis is looking to build a differentiated next-generation pipeline in oncology through strategic collaborations. The successful development of additional candidates will diversify its revenue base and reduce dependence on Cabometyx, which is approved for advanced RCC and previously treated hepatocellular carcinoma (HCC), maintaining momentum on label expansions.In January 2021, the FDA approved Cabometyx in combination with immuno-oncology drug Opdivo for the first-line treatment of patients with advanced RCC.  Sales of the drug saw an increase in volume thereafter driven by the strong uptake for the combination therapy of Cabometyx and Opdivo.However, competition is stiff in this space and hence Exelixis is looking to develop its portfolio beyond Cabometyx.Merck’s MRK Keytruda, in combination with Pfizer’s PFE Inlyta, is also indicated for the first-line treatment of patients with advanced RCC.Merck’s Keytruda, an anti-PD-1 therapy, is approved for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence, following nephrectomy, or following nephrectomy and resection of metastatic lesions.Pfizer’s Inlyta has shown strong performance, driven by continued adoption in the United States and Europe. Pfizer’s older drug Sutent is also approved for advanced RCC.Exelixis currently carries a Zacks Rank #4 (Sell).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.  Infrastructure Stock Boom to Sweep America A massive push to rebuild the crumbling U.S. infrastructure will soon be underway. It’s bipartisan, urgent, and inevitable. Trillions will be spent. Fortunes will be made. The only question is “Will you get into the right stocks early when their growth potential is greatest?” Zacks has released a Special Report to help you do just that, and today it’s free. Discover 5 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.Download FREE: How to Profit from Trillions on Spending for Infrastructure >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Bristol Myers Squibb Company (BMY): Free Stock Analysis Report Pfizer Inc. (PFE): Free Stock Analysis Report Merck & Co., Inc. (MRK): Free Stock Analysis Report Exelixis, Inc. (EXEL): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksDec 16th, 2021

Affimed (AFMD) Starts AFM24-102 Study With Roche"s Tecentriq

Affimed (AFMD) starts recruiting patients in a phase I/IIa study to evaluate the combination of AFM24 and Roche's atezolizumab in solid tumors. Affimed AFMD announced that it has initiated enrolling patients in a phase I/IIa AFM24-102 study to evaluate the safety, tolerability, pharmacokinetics and efficacy of its EGFR/CD16A targeted innate cell engager, AFM24, in combination with Roche’s RHHBY Tecentriq (atezolizumab) to treat patients with solid tumors.Affimed will evaluate this combination in solid tumor indications that include non-small cell lung cancer (EGFR-wildtype), gastric- and gastroesophageal junction cancers, and pancreatic/hepatocellular/biliary tract cancer. It is to be noted that all patients participating in this study should have failed at least one prior line of treatment before receiving this combination.The AFM24-102 study will consist of two parts. While the first part is a dose escalation phase to determine the maximum tolerated dose or recommended phase II dose of AFM24 plus atezolizumab, the second part is an expansion phase that will determine the safety of the AFM24-atezolizumab combination.Affimed’s stock has rallied 17.4% so far this year against the industry’s 20.5% fall.Image Source: Zacks Investment ResearchApart from this study, Affimed is also evaluating AFM24 in other clinical studies. A phase I/IIa AFM24-101 study is evaluating AFM24 as a monotherapy in patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies.The company is also evaluating AFM24 in combination with NKGen Biotech’s autologous NK cell therapy, SNK01, in a phase I/IIa study in solid tumors, initiated by Affimed last month.We note that atezolizumab is an anti-PD-L1 checkpoint inhibitor marketed by Roche under the trade name Tecentriq. Tecentriq is Roche’s leading immuno-oncology drug for multiple indications.Affimed N.V. Price Affimed N.V. price | Affimed N.V. QuoteZacks Rank & Stocks to ConsiderAffimed presently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the same sector include IVERIC bio ISEE and Precision BioSciences DTIL. While Precision BioSciences sports a Zacks Rank #1 (Strong Buy), IVERIC bio currently carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.Precision BioSciences’ loss per share estimates for 2021 have narrowed from $1.17 to $0.65 in the past 30 days. The same for 2022 has narrowed from $2.39 to $1.91 in the past 30 days. Shares of Precision BioScienceshave risen 9.2% in the year so far.Earnings of Precision BioSciences beat estimates in all the last four quarters, delivering a surprise of 76.9%, on average.IVERIC bio’s loss per share estimates for 2021 have narrowed from $1.18 to $1.09 in the past 30 days. The same for 2022 has narrowed from $1.17 to $1.03 in the past 30 days. Shares of IVERIC bio have gained 114% in the year so far.Earnings of IVERIC bio missed estimates in three of the last four quarters and surpassed expectations once, with the negative surprise being 5.6%, on average. Zacks’ Top Picks to Cash in on Artificial Intelligence This world-changing technology is projected to generate $100s of billions by 2025. From self-driving cars to consumer data analysis, people are relying on machines more than we ever have before. Now is the time to capitalize on the 4th Industrial Revolution. Zacks’ urgent special report reveals 6 AI picks investors need to know about today.See 6 Artificial Intelligence Stocks With Extreme Upside Potential>>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Roche Holding AG (RHHBY): Free Stock Analysis Report Affimed N.V. (AFMD): Free Stock Analysis Report Precision BioSciences, Inc. (DTIL): Free Stock Analysis Report IVERIC bio, Inc. (ISEE): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksDec 10th, 2021

Blueprint Medicines" (BPMC) Ayvakit Aids Growth Amid Rivalry

Blueprint Medicines' (BPMC) Ayvakit, which has been approved to treat PDGFRA Exon 18 mutant gastrointestinal stromal tumors, has seen strong uptake since approval. However, stiff competition remains a headwind. Blueprint Medicines Corporation’s BPMC lead drug, Ayvakit (avapritinib), was approved by the FDA for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors (“GIST”), harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations, in January 2020. The European Commission has granted conditional marketing authorization to Ayvakyt as a monotherapy for the treatment of adult patients with unresectable/metastatic GIST, harboring the PDGFRA D842V mutation.Ayvakit/Ayvakyt has witnessed strong uptake since its launch. In the first nine months of 2021, the drug generated sales worth $32.9 million, reflecting a significant year-over-year increase. Label expansion of the drug is driving sales too.Ayvakit received label expansion nod from the FDA in June 2021 to treat advanced systemic mastocytosis (“SM”), a rare and debilitating disease. Ayvakit is being evaluated in the phase II PIONEER study for treating non-advanced SM. Top-line data from the same is anticipated in mid-2022.Shares of Blueprint Medicines have declined 12.2% so far this year compared with the industry’s decrease of 18.1%.Image Source: Zacks Investment ResearchWe note that Blueprint Medicines is co-developing another cancer drug, Gavreto (pralsetinib), with Roche RHHBY for treating patients with various types of RET-altered thyroid cancers and other solid tumors.In July 2021, Blueprint Medicines transferred the responsibilities of booking U.S. product sales of Gavreto to Roche. The company only records the share of profit and loss for Gavreto in financial results and does not record any net product revenues from Gavreto sales.The FDA approved Gavreto for the treatment of patients with advanced/metastatic rearranged during transfection RET-mutant and RET fusion-positive thyroid cancer in December 2020. Gavretois also approved for the treatment of adults with metastatic RET fusion-positive non-small-cell lung cancer.This apart, Blueprint Medicines has other promising pipeline candidates that are progressing well, targeting various cancer indications.Blueprint Medicines is riding on the success of Ayvakit. The company’s current product revenues solely comprise sales from Ayvakit, which narrows its revenues stream. Hence, any regulatory setback for Ayvakit could hurt the stock in the days ahead.Also, Ayvakit faces competition from Deciphera Pharmaceuticals' DCPH Qinlock (ripretinib), which is approved for the treatment of fourth-line GIST. In November 2021, the European Commission approved Qinlock for the same indication.Please note that Deciphera is looking to streamline commercial operations for Qinlock in the United States and focus on commercialization efforts on a select number of key European markets for the medicine.Zacks Rank & Stock to ConsiderBlueprint Medicines currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Sarepta Therapeutics, Inc. SRPT, which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.Sarepta Therapeutics’ loss per share estimates have narrowed 31.3% for 2021 and 26% for 2022, over the past 60 days.Earnings of Sarepta Therapeutics have surpassed estimates in two of the trailing four quarters, and missed the same on the other two occasions. Zacks' Top Picks to Cash in on Artificial Intelligence In 2021, this world-changing technology is projected to generate $327.5 billion in revenue. Now Shark Tank star and billionaire investor Mark Cuban says AI will create "the world's first trillionaires." Zacks' urgent special report reveals 3 AI picks investors need to know about today.See 3 Artificial Intelligence Stocks With Extreme Upside Potential>>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Roche Holding AG (RHHBY): Free Stock Analysis Report Sarepta Therapeutics, Inc. (SRPT): Free Stock Analysis Report Blueprint Medicines Corporation (BPMC): Free Stock Analysis Report Deciphera Pharmaceuticals, Inc. (DCPH): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksDec 3rd, 2021

Adagene (ADAG) Gets FDA Nod to Begin Solid Tumor Antibody Study

The FDA grants Adagene (ADAG) a clearance to initiate clinical studies of its investigational candidate ADG116 in combination with pembrolizumab to treat advanced/metastatic solid tumors. Adagene ADAG announced that the FDA cleared the investigational new drug (IND) application, which sought approval for initiating a clinical study of its anti-CTLA-4 monoclonal antibody (mAb) ADG116 in combination with Keytruda (pembrolizumab) in patients with advanced/metastatic solid tumors.Adagene plans to begin dosing the first patient in a phase I/II study ADG116-P001 in early 2022. The study will evaluate the safety and tolerability of the combination of ADG116 with Keytruda, determine the maximum tolerated dose and assess the combo’s preliminary efficacy.Shares of Adagene were up 22.2% in after-hours trading following the news above. However, the stock has plunged 71.7% so far this year compared with the industry’s 15.2% decline.Image Source: Zacks Investment ResearchDeveloped by Adagene using its proprietary NEObody platform technology, ADG116 is designed with a soft ligand blocking to address the safety concerns associated with the existing CTLA-4 therapeutics.ADG116 targets a unique conserved epitope of CTLA-4 with enhanced efficacy by potent Treg depletion in the tumor microenvironment (TME).Pembrolizumab is an anti-PD-1 therapy developed by Merck MRK. The same is marketed by Merck under the brand name Keytruda. Adagene entered into a clinical collaboration and supply agreement with Merck to develop ADG116 in combination with pembrolizumab for advanced/metastatic solid tumors.Keytruda is currently the top-line driver for Merck. Its revenues are gaining from a continued uptake for lung cancer and an increasing usage for other cancer indications.  Keytruda is already approved for treating many cancers globally and is continuously growing and expanding into new indications and markets globally. During third-quarter 2021, Merck recorded $4.5 billion sales from Keytruda.Apart from ADG116, Adagene has two product candidates in its pipeline: an anti-CD137 agonist called ADG106 and an anti-CTLA-4 mAb product candidate, ADG126. The company also has clinical collaborations and supply agreements with Merck for each of these clinical candidates.While ADG126 is being evaluated in combination with pembrolizumab in patients with advanced/metastatic solid tumors, ADG106 is being evaluated in combination with pembrolizumabfor advanced or metastatic solid and/or hematological malignancies.Adagene Inc. Sponsored ADR Price Adagene Inc. Sponsored ADR price | Adagene Inc. Sponsored ADR QuoteZacks Rank & Stocks to ConsiderAdagene currently carries a Zacks Rank #3 (Hold). Two better-ranked stocks in the same sector are Precision BioSciences DTIL and IVERIC bio ISEE. While Precision BioSciences sports a Zacks Rank #1 (Strong Buy), IVERIC bio carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.Precision BioSciences’ loss per share estimates for 2021 have narrowed from $1.17 to 65 cents in the past 30 days. The same for 2022 has narrowed from $2.39 to $1.91 in the past 30 days. Shares of Precision BioSciences have risen 4.4% in the year so far.Earnings of Precision BioSciences beat estimates in all the last four quarters, delivering a surprise of 76.9%, on average.IVERIC bio’s loss per share estimates for 2021 have narrowed from $1.18 to $1.12 in the past 30 days. The same for 2022 has narrowed from $1.17 to $1.10 in the past 30 days. Shares of IVERIC bio have gained 117.7% in the year so far.The bottom line of IVERIC bio missed estimates in three of the last four quarters and surpassed expectations once, the negative surprise being 5.6%, on average. Tech IPOs With Massive Profit Potential: Last years top IPOs surged as much as 299% within the first two months. With record amounts of cash flooding into IPOs and a record-setting stock market, this year could be even more lucrative. See Zacks’ Hottest Tech IPOs Now >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Merck & Co., Inc. (MRK): Free Stock Analysis Report Precision BioSciences, Inc. (DTIL): Free Stock Analysis Report IVERIC bio, Inc. (ISEE): Free Stock Analysis Report Adagene Inc. Sponsored ADR (ADAG): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksNov 30th, 2021

Genetron Health Reports Third Quarter 2021 Unaudited Financial Results

BEIJING, Nov. 30, 2021 (GLOBE NEWSWIRE) -- Genetron Holdings Limited (("Genetron Health" or the "Company", NASDAQ:GTH), a leading precision oncology platform company in China that specializes in offering molecular profiling tests, early cancer screening products and companion diagnostics development, today reported its unaudited preliminary financial results for the third quarter ended September 30, 2021. Third Quarter and Recent Highlights Financials: Recorded total revenue of RMB 152.5 million (US $23.7 million) for the third quarter of 2021, representing a 36.2% increase over the same period of 2020 LDT revenue was RMB 93.0 million (US $14.4 million) in the third quarter of 2021, representing 30.2% growth compared to the prior year period IVD revenue was RMB 51.3 million (US $8.0 million) in the third quarter of 2021, representing 70.5% growth compared to the prior year period Achieved gross margin of 69.0% for the third quarter 2021 compared to 62.2% in the same period of 2020, primarily driven by improvements in both the LDT and IVD business lines Early screening franchise update: Genetron has broadened its registrational strategy for its early screening program for hepatocellular carcinoma (HCC). The Company has initiated enrollment for a PCR-based trial in November, with plans to enroll the NGS-based trial in the next few months. Genetron anticipates potential NMPA approvals for both assays in 2023 Developed a multi-omics blood-based CRC early screening assay, which was trained in a retrospective cohort of 100 cases and 100 controls, and validated in an independent cohort of the same size. The assay achieved >91% sensitivity with the specificity of 95%. Full details are planned to be released through a publication in 2022 MRD franchise update: Formed a co-development agreement with AstraZeneca R&D China for personalized MRD tests for solid tumors in China. Our partner plans to incorporate the co-developed tests for China-specific studies. This is an exclusive, multi-year collaboration (see detailed release here) Entered into an exclusive agreement with Fosun Pharma to commercialize Seq-MRD® in China, marking the Company's first product launch for hematologic cancer and MRD detection Publications: Early Screening: Clinical results and technology findings of Genetron Health's early liver cancer screening product for hepatocellular carcinoma (HCC), HCCscreen™, were included in an expert consensus and was published in the Chinese Journal of Hepatology, an influential publication among liver physicians in China MRD: Journal of Hematology & Oncology published an analysis of a personalized MRD assay developed based on Mutation Capsule technology. The assay has shown excellent sensitivity to detect 0.001% tumor DNA from peritoneal lavage fluid samples for precise prediction of peritoneal dissemination in gastric cancer patients Bioinformatics: Briefings in Bioinformatics published enhanced variant caller performance data that was achieved by Genetron Health's bioinformatics team Others: Established a strategic partnership with NeoGenomics (NASDAQ:NEO) to drive global oncology drug R&D as well as with IMPACT Therapeutics to drive development of a synthetic lethal product pipeline Obtained CE Mark for Onco PanScan™, the Company's large panel product that covers over 800 genes "Despite COVID's impact on our third quarter financial results, we achieved strong year-over-year revenue growth of 36.2%, marked by more than 70% increase in our in-hospital (IVD) sales along with significant gross margin improvement. Operationally, we've had many positive updates, which included the initiation of our first registrational trial for HCC early screening, new MRD partnerships, and recognition in multiple influential publications," remarked Mr. Sizhen Wang, co-founder and CEO of Genetron Health. "Based on the continued enforcement of "zero COVID" strategy in China, we anticipate a significantly tougher operating environment in the fourth quarter. Despite this short-term challenge, we remain laser focused on driving our clinically differentiated pipeline of comprehensive precision oncology diagnostics. Our long-term outlook remains unchanged as we continue to execute on our strategies, and we anticipate multiple data and trial updates from our key programs in the coming months. In addition, the macro environment remains favorable for Genetron, thanks to continued policy tailwinds in China that aim to improve healthcare options for local citizens." Third Quarter 2021 Unaudited Preliminary Financial ResultsTotal revenue for the third quarter of 2021 increased by 36.2% to RMB 152.5 million (US $23.7 million) from RMB 112.0 million in the same period of 2020. Diagnosis and monitoring revenue increased by 42.2% to RMB 144.3 million (US $22.4 million) in the third quarter of 2021 from RMB 101.5 million in the same period of 2020. The increase was primarily driven by the growth in the revenue generated from the sale of both LDT & IVD products. Revenue generated from the provision of LDT services increased by 30.2% to RMB 93.0 million (US $14.4 million) during the third quarter of 2021 from RMB 71.4 million in the same period of 2020, primarily driven by increased sales of HCC early screening tests. LDT diagnostic tests sold in the third quarter 2021 totaled approximately 5,900 units.   Revenue generated from sales of IVD products increased by 70.5% to RMB 51.3million (US $8.0 million) in the third quarter of 2021 from RMB 30.1 million in the third quarter of 2020. The increase was driven by sales of the Genetron S5 instrument and 8-gene Lung Cancer Assay (Tissue). Contracted in-hospital partners(as of the end of the period indicated)                 3Q20 4Q20 1Q21 2Q21 3Q21   IVD In-hospital partners 20 22 23 28 29                   3Q20 4Q20 1Q21 2Q21 3Q21   Total in-hospital partners(1) 38 40 42 50 54   Note:(1) The number of total in-hospital partners include both sales of LDT services and IVD products.       Revenue generated from development services decreased by 21.4% to RMB 8.2 million (US $1.3 million) in the third quarter of 2021, from RMB 10.4 million in the same period of 2020. The decrease was mainly due to the decline in sequencing services, as the Company continued to focus on higher margin biopharmaceutical services. Biopharmaceutical revenue continued to grow compared to the same period of 2020. Gross profit increased by 51.1% to RMB 105.2 million (US $16.3 million) in the third quarter 2021 from RMB 69.6 million in the same period of 2020. Gross margin improved to 69.0% for the third quarter of 2021, compared to 62.2% in the same period of 2020, primarily due to higher gross margins for both the LDT and IVD business lines. Selling expenses increased by 56.3% to RMB 94.6 million (US $14.7 million) in the third quarter of 2021 from RMB 60.6 million in the same period of 2020. Selling expenses as a percentage of revenues was 62.0% in the third quarter of 2021, compared to 54.1% in the same period of 2020. The increase was primarily driven by increased headcount to expand Genetron's core business as well as early screening sales teams. Administrative expenses increased by 94.1% to RMB 63.0 million (US $9.8 million) in the third quarter of 2021 from RMB 32.4 million in the same period of 2020. Administrative expenses as a percentage of revenues increased to 41.3% in the third quarter of 2021 from 29.0% in the third quarter of 2020. The increase was mainly driven by higher headcount, professional fees, IT expenses, and share-based compensation. Research and development expenses increased by 61.7% to RMB 62.4 million (US $9.7 million) in the third quarter of 2021 from RMB 38.6 million in the same period of 2020. Research and development expenses as a percentage of revenues increased to 40.9% in the third quarter of 2021 from 34.4% in the same period of 2020. The increases were driven by higher R&D headcount and related expenses, as well as continued innovation efforts, including product development and clinical trial activities. Loss for the period was RMB 130.1 million (US $20.2 million) for the three months ended September 30, 2021, compared to RMB 48.0 million for the three months ended September 30, 2020. Non-IFRS loss for the period, defined as loss for the period excluding share-based compensation expenses, fair value change and other loss of financial instruments with preferred rights, was RMB109.9 million (US $17.1 million) for the three months ended September 30, 2021, compared to RMB 43.7 million for the three months ended September 30, 2020. Please refer to the section in this press release titled "Non-IFRS Financial Measures" for details. Basic loss per share attributable to ordinary shareholders of the Company was RMB 0.28 (US $0.04) for the third quarter of 2021, compared with a basic loss per share attributable to ordinary shareholders of the Company of RMB 0.11 for the same period of 2020. Excluding share-based compensation expenses, fair value change of financial instruments with preferred rights and other loss of financial instruments with preferred rights, non-IFRS basic loss per share attributable to ordinary shareholders of the Company was RMB 0.24 (US $0.04) for the third quarter of 2021, compared with non-IFRS basic loss per share attributable to ordinary shareholders of the Company of RMB 0.10 for the same period of 2020. Diluted loss per share attributable to ordinary shareholders of the Company is equivalent to basic loss per share attributable to ordinary shareholders of the Company. Each ADS represents of five ordinary shares, par value US $0.00002 per share. Please refer to the section in this press release titled "Non-IFRS Financial Measures" for details. As of September 30, 2021, cash and cash equivalents, restricted cash and current financial assets at fair value through profit or loss were RMB 1,005.3 million (US $156.0 million). 2021 Financial GuidanceBased on the continued enforcement of the "zero COVID" strategy in China and the resulting sustained restrictions across Genetron's major markets, the Company is revising its full year 2021 revenue guidance to be around RMB 530 million, representing approximately 24.9% growth over the Company's full year 2020 revenue. Conference CallA conference call and webcast to discuss the results will be held at 8:30 a.m. U.S. Eastern Time on November 30, 2021 (or at 9:30 p.m. Beijing Time on November 30, 2021). Interested parties may listen to the conference call by dialing numbers below: United States: +1-332-208-9468 China Domestic: 400-820-5286 Hong Kong: +852-3018-6771 International:  +65-6713-5590 Conference ID: 5848053 Participants are encouraged to dial into the call at least 15 minutes in advance due to high call volumes. A replay will be accessible through December 7, 2021 by dialing the following numbers: United States: +1-855-452-5696 International: +61-2-8199-0299 Conference ID: 5848053 A simultaneous webcast of the conference call will be available on the "News and Presentations" page of the Investors section of the Company's website. A replay of the webcast will be available for 30 days following the event. For more information, please visit ir.genetronhealth.com. Exchange Rate Information All translations made in the financial statements or elsewhere in this press release made from RMB into United States dollars ("US$") are solely for convenience and calculated at the rate of US$1.00=RMB 6.4434, representing the exchange rate as of September 30, 2021, set forth in the H.10 statistical release of the U.S. Federal Reserve Board. No representation is made that the RMB amounts could have been, or could be, converted, realized or settled into US$ at that rate, or at any other rate, on September 30, 2021. Non-IFRS Financial Measures The Company uses non-IFRS loss and non-IFRS loss per share attributable to ordinary shareholders of the Company for the year/period, which are non-IFRS financial measures, in evaluating its operating results and for financial and operational decision-making purposes. The Company believes that non-IFRS loss and non-IFRS loss per share attributable to ordinary shareholders of the Company help identify underlying trends in the Company's business that could otherwise be distorted by the effect of certain expenses that the Company includes in its loss for the year/period. The Company believes that non-IFRS loss and non-IFRS loss per share attributable to ordinary shareholders of the Company for the year/period provide useful information about its results of operations, enhances the overall understanding of its past performance and future prospects and allows for greater visibility with respect to key metrics used by its management in its financial and operational decision-making. Non-IFRS loss and non-IFRS loss per share attributable to ordinary shareholders of the Company for the year/period should not be considered in isolation or construed as an alternative to operating profit, loss for the year/period or any other measure of performance or as an indicator of its operating performance. Investors are encouraged to review non-IFRS loss and non-IFRS loss per share attributable to ordinary shareholders of the Company for the year/period and the reconciliation to its most directly comparable IFRS measures. Non-IFRS loss and non-IFRS loss per share attributable to ordinary shareholders of the Company for the year/period presented here may not be comparable to similarly titled measures presented by other companies. Other companies may calculate similarly titled measures differently, limiting their usefulness as comparative measures to the Company's data. The Company encourages investors and others to review its financial information in its entirety and not rely on a single financial measure. Non-IFRS loss and non-IFRS loss per share attributable to ordinary shareholders of the Company for the year/period represent loss for the year/period excluding share-based compensation expenses, fair value change of financial instruments with preferred rights and other loss of financial instruments with preferred rights (if applicable). Please see the "Unaudited Non-IFRS Financial Measures" included in this press release for a full reconciliation of non-IFRS loss for the year/period to loss for the year/period and non-IFRS loss per share attributable to ordinary shareholders of the Company for the year/period to loss per share attributable to ordinary shareholders of the Company for the year/period. About Genetron Holdings LimitedGenetron Holdings Limited ("Genetron Health" or the "Company") (NASDAQ:GTH) is a leading precision oncology platform company in China that specializes in cancer molecular profiling and harnesses advanced technologies in molecular biology and data science to transform cancer treatment. The Company has developed a comprehensive oncology portfolio that covers the entire spectrum of cancer management, addressing needs and challenges from early screening, diagnosis and treatment recommendations, as well as continuous disease monitoring and care. Genetron Health also partners with global biopharmaceutical companies and offers customized services and products. For more information, please visit ir.genetronhealth.com. Safe Harbor Statement This press release contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about the Company's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and a number of factors could cause actual results to differ materially from those contained in any forward-looking statement. In some cases, forward-looking statements can be identified by words or phrases such as "may", "will," "expect," "anticipate," "target," "aim," "estimate," "intend," "plan," "believe," "potential," "continue," "is/are likely to" or other similar expressions. Further information regarding these and other risks, uncertainties or factors is included in the Company's filings with the SEC. All information provided in this press release is as of the date of this press release, and the Company does not undertake any duty to update such information, except as required under applicable law. Investor Relations Contact US: Hoki Luk Head of Investor Relations Email: hoki.luk@genetronhealth.com Phone: +1 (408) 891-9255 Philip Trip TaylorVice President | Gilmartin Groupir@genetronhealth.com Media Relations ContactYanrong ZhaoGenetron Healthyanrong.zhao@genetronhealth.com Edmond LococoICREdmond.Lococo@icrinc.com Mobile: +86 138-1079-1408genetron.pr@icrinc.com GENETRON HOLDINGS LIMITED UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF LOSS   For the three months ended   For the nine months ended       September 30, 2020 September 30, 2021   September 30, 2020 September 30, 2021   RMB'000 RMB'000 US$'000   RMB'000 RMB'000 US$'000 Revenue 111,963     152,541     23,674     290,541     385,087     59,765   Cost of revenue (42,331 )   (47,306 )   (7,342 )   (114,448 )   (130,839 )   (20,306 )                 Gross profit 69,632     105,235     16,332     176,093     254,248     39,459                   Selling expenses (60,558 )   (94,625 )   (14,686 )   (175,000 )   (242,812 )   (37,684 ) Administrative expenses (32,440 )   (62,981 )   (9,774 )   (81,969 )   (162,161 )   (25,167 ) Research and development expenses (38,556 )   (62,364 )   (9,679 )   (96,030 )   (168,500 )   (26,151 ) Net impairment losses on financial and contract assets (1,107 )   (10,437 )   (1,620 )   (2,097 )   (23,741 )   (3,684 ) Other income/(loss) - net 3,819     334     52     (513 )   8,945     1,388                   Operating expenses (128,842 )   (230,073 )   (35,707 )   (355,609 )   (588,269 )   (91,298 )                 Operating loss (59,210 )   (124,838 ).....»»

Category: earningsSource: benzingaNov 30th, 2021

NuCana Reports Third Quarter 2021 Financial Results and Provides Business Update

Enrolled Required Number of Patients to Conduct First Interim Analysis in Phase 3 Biliary Tract Cancer Study in the First Half of 2022 Received Fast Track Designation from FDA for Acelarin for the Treatment of Patients with Biliary Tract Cancer Announced Additional Encouraging Clinical Data for NUC-3373 and NUC-7738 at ESMO Multiple Near-Term Study Initiations and Data Announcements Expected EDINBURGH, United Kingdom, Nov. 18, 2021 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ:NCNA) announced financial results for the third quarter ended September 30, 2021 and provided an update on its broad clinical program with its transformative ProTide therapeutics. As of September 30, 2021, NuCana had cash and cash equivalents of £71.0 million compared to £73.4 million at June 30, 2021 and £87.4 million as of December 31, 2020. NuCana continues to advance its various clinical programs and reported a net loss of £8.0 million for the quarter ended September 30, 2021, as compared to a loss of £8.4 million for the quarter ended September 30, 2020. Basic and diluted loss per share was £0.15 for the quarter ended September 30, 2021, as compared to £0.24 per share for quarter ended September 30, 2020. "NuCana had a very productive third quarter," said Hugh S. Griffith, NuCana's Founder and Chief Executive Officer. "We completed enrollment of 418 evaluable patients required to conduct the first interim analysis in the Phase III study (NuTide:121) evaluating Acelarin combined with cisplatin compared to the global standard of care, gemcitabine plus cisplatin, as a first-line treatment for patients with advanced biliary tract cancer. We believe that a statistically significant improvement in the Objective Response Rate (ORR) at the first interim analysis, accompanied by positive trends in other endpoints, has the potential to allow for accelerated approval of a new drug application (NDA) for Acelarin in the United States. We look forward to announcing the outcome of the first interim analysis in the first half of 2022." Mr. Griffith continued: "Additionally, we announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Acelarin (NUC-1031) for the treatment of patients with biliary tract cancer. With both Fast Track and Orphan Drug designations in place, we look forward to working closely with the FDA in our efforts to gain approval for Acelarin as the first approved front-line treatment option for patients with biliary tract cancer." "We also announced positive data at the European Society for Medical Oncology (ESMO) Congress 2021 for three of our programs: NUC-3373 in patients with advanced colorectal cancer (NuTide:302); NUC-3373 in patients with advanced solid tumors (NuTide:301); and NUC-7738 in patients with advanced solid tumors (NuTide:701)," said Mr. Griffith. "Building on the exciting data presentations we made earlier in the year at AACR and ASCO GI, the data presented at ESMO continue to support the broad potential of our ProTide technology by demonstrating encouraging efficacy signals, durable anti-cancer activity and favorable safety and pharmacokinetic profiles." Mr. Griffith added: "We would like to express our sincere appreciation to Rafaèle Tordjman who retired as a director in September after ten years on the NuCana Board. We are also pleased to have welcomed Elliott Levy, who was most recently SVP of Global Development and R&D Strategy at Amgen, to the NuCana Board in November." Mr. Griffith concluded: "Throughout the remainder of 2021 and in the first half of 2022, we look forward to achieving multiple milestones, including: initiating a Phase III study of NUC-3373 in combination with other agents for patients with colorectal cancer, subject to anticipated regulatory feedback; reporting additional data from the Phase Ib / Phase II study of NUC-3373 in combination with other agents for patients with colorectal cancer; and initiating and reporting data from the Phase II study of NUC-7738 in patients with solid tumors." Anticipated Milestones: Q4 2021 & H1 2022 • Acelarin (a ProTide transformation of gemcitabine)       In the first half of 2022, NuCana expects to:         • Announce whether the overall response rate objective for the first interim data from the Phase III study of Acelarin combined with cisplatin as a first-line treatment for patients with advanced biliary tract cancer has been met, which may allow for accelerated approval of an NDA submission in the United States.         • NUC-3373 (a ProTide transformation of 5-FU)       In Q4 2021, NuCana expects to:         • Initiate a Phase III study of NUC-3373 in combination with other agents for patients with colorectal cancer, subject to anticipated regulatory feedback.           In the first half of 2022, NuCana expects to:         • Initiate a Phase Ib / Phase II basket study of NUC-3373 in combination with other agents in a variety of solid tumors; and     • Expand the Phase Ib / Phase II study of NUC-3373 in combination with other agents for patients with colorectal cancer to include second-line colorectal cancer patients, as well as evaluate NUC-3373 in combination with monoclonal antibodies such as bevacizumab (Avastin®).         • NUC-7738 (a ProTide transformation of 3'-deoxyadenosine)       In Q4 2021, NuCana expects to:         • Initiate the Phase II study of NUC-7738 in patients with solid tumors.           In the first half of 2022, NuCana expects to:         • Report data from the Phase II study of NUC-7738 in patients with solid tumors. About NuCana NuCana is a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for patients with cancer by applying our ProTide technology to transform some of the most widely prescribed chemotherapy agents, nucleoside analogs, into more effective and safer medicines. While these conventional agents remain part of the standard of care for the treatment of many solid and hematological tumors, their efficacy is limited by cancer cell resistance mechanisms and they are often poorly tolerated. Utilizing our proprietary technology, we are developing new medicines, ProTides, designed to overcome key cancer resistance mechanisms and generate much higher concentrations of anti-cancer metabolites in cancer cells. NuCana's robust pipeline includes three ProTides in clinical development. Acelarin and NUC-3373, are new chemical entities derived from the nucleoside analogs gemcitabine and 5-fluorouracil, respectively, two widely used chemotherapy agents. Acelarin is in a Phase 3 study for patients with advanced biliary tract cancer. NUC-3373 is in a Phase 1b/2 study in patients with metastatic colorectal cancer. Our third ProTide, NUC-7738, is a transformation of a novel anti-cancer nucleoside analog (3'-deoxyadenosine) and is in a Phase 1 study for patients with advanced solid tumors. Forward-Looking Statements This press release may contain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on the beliefs and assumptions and on information currently available to management of NuCana plc (the "Company"). All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements concerning the Company's planned and ongoing clinical studies for the Company's product candidates and the potential advantages of those product candidates, including Acelarin, NUC-3373 and NUC-7738; the initiation, enrollment, timing, progress, release of data from and results of those planned and ongoing clinical studies; the potential benefits of Fast Track designation for Acelarin and the Company's ability to submit an NDA for Acelarin under the FDA's accelerated approval program or at all; the Company's goals with respect to the development, regulatory pathway and potential use, if approved, of each of its product candidates; and the utility of prior non-clinical and clinical data in determining future clinical results. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other comparable terminology. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the "Risk Factors" section of the Company's Annual Report on Form 20-F for the year ended December 31, 2020 filed with the Securities and Exchange Commission ("SEC") on March 4, 2021, and subsequent reports that the Company files with the SEC. Forward-looking statements represent the Company's beliefs and assumptions only as of the date of this press release. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, the Company assumes no obligation to publicly update any forward-looking statements for any reason after the date of this press release to conform any of the forward-looking statements to actual results or to changes in its expectations. Unaudited Condensed Consolidated Statements of Operations                   For the three months endedSeptember 30,   For the nine months endedSeptember 30,     2021   2020     2021   2020       (in thousands, except per share data)     £   £     £   £   Research and development expenses   (8,971 ) (6,117 )   (26,200 ) (17,918 ) Administrative expenses   (2,277 ) (1,906 )   (6,456 ) (5,144 ) Net foreign exchange gains (losses)   1,274  .....»»

Category: earningsSource: benzingaNov 18th, 2021

Amgen"s (AMGN) KRAS Inhibitor Gets CHMP Nod for Lung Cancer

The CHMP gives a positive opinion on, and recommends approval to Amgen's (AMGN) KRAS inhibitor, Lumykras for the treatment of advanced non-small-cell lung cancer. Amgen Inc. AMGN announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion on, and has recommended conditional marketing authorization to its KRAS inhibitor, Lumykras (sotorasib), for the treatment of adult patients with KRAS G12C mutated advanced non-small-cell lung cancer (“NSCLC”) whose disease has progressed after at least one prior line of systemic therapy.The opinion will now be reviewed by the European Commission with a decision expected by mid-January 2022. If approved, Lumykras will become the first targeted therapy to be available for the KRAS G12C mutation in the European Union.The positive CHMP opinion was based on data from the phase II CodeBreaK 100 study that evaluated patients with the KRAS G12C mutation. Data from the same showed that treatment with once-daily Lumykras (960 mg) led to an objective response rate of 37.1% and a median duration of response of 11.1 months. 80.6% patients treated with Lumakras achieved disease control while the median overall survival was 12.5 months.Per the company, KRAS G12C mutations are present in approximately 13-15% of non-squamous NSCLC patients. Lumykras has the potential to be the new standard of care for NSCLC patients with this mutation in the EU.Shares of Amgen have declined 8% so far this year compared with the industry’s decrease of 13.9%.Image Source: Zacks Investment ResearchWe note that Lumykras is marketed under the trade name Lumakras in the United States. The FDA approved Lumakras for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, following at least one prior systemic therapy in May this year. Lumakras generated sales worth $36 million in the third quarter of 2021.Please note that tumors characterized by KRAS, a common cancer mutation, are commonly associated with poor prognosis and resistance to therapy.Amgen is conducting a phase II monotherapy study on sotorasib in second-line plus NSCLC and in advanced colorectal cancer (“CRC”) patients. A phase II monotherapy study in patients with KRAS G12C-mutated solid tumors, other than those suffering from NSCLC and CRC, is ongoing. A phase II study in first-line NSCLC (in patients who are either PD-L1 negative or carrying STK11 mutations) was initiated in the third quarter of 2021 while a phase III study on Lumakras + Vectibix in third-line CRC is expected to begin enrollment in the fourth quarter of 2021. Amgen is also conducting phase Ib combination studies with PD-1, MEK, EGFR and other targeted therapies with some initial data expected in first half of 2022.We note that many companies have KRAS G12C inhibitors in their pipelines being developed for various cancer indications. Small biotech, Mirati Therapeutics MRTX has adagrasib, a KRAS G12C inhibitor, in its pipeline. Earlier this month, Mirati initiated the submission of the new drug application (NDA) for adagrasib to treat patients with previously treated KRAS G12C-mutated NSCLC under the Real-Time Oncology Review pilot program.Mirati is also developing adagrasib for other cancer indications.Zacks Rank & Stocks to ConsiderAmgen currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Galera Therapeutics, Inc. GRTX and Editas Medicine, Inc. EDIT, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.Galera Therapeutics’ loss per share estimates have narrowed 19.5% for 2021 and 32.3% for 2022, over the past 60 days.Earnings of Galera Therapeutics have surpassed estimates in only one of the trailing four quarters, and missed the same on the other three occasions.Editas Medicine’s loss per share estimates have narrowed 11.9% for 2021 and 4.1% for 2022, over the past 60 days.Editas Medicine’s earnings have surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions. 5 Stocks Set to Double Each was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2021. Previous recommendations have soared +143.0%, +175.9%, +498.3% and +673.0%. Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.Today, See These 5 Potential Home Runs >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Amgen Inc. (AMGN): Free Stock Analysis Report Mirati Therapeutics, Inc. (MRTX): Free Stock Analysis Report Editas Medicine, Inc. (EDIT): Free Stock Analysis Report Galera Therapeutics, Inc. (GRTX): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksNov 15th, 2021

Vaccinex Reports Third Quarter 2021 Financial Results and Provides Corporate Update

Enrollment underway in combination Phase 1b/2 study of pepinemab with KEYTRUDA® in Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Patient screening and enrollment underway in Phase 1/2a study of pepinemab in Alzheimer's disease Engaged in partnering discussions for a randomized Phase 3 trial in Huntington's disease ROCHESTER, N.Y., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (NASDAQ:VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, today announced financial results for the third quarter ended September 30, 2021 and provided a corporate update. "We made steady progress on our pepinemab clinical programs since our last quarterly update. Enrollment is now underway in the Phase 1b/2 head and neck cancer trial and the Phase 1/2a Alzheimer's disease trial, two of the serious indications in which SEMA4D is overexpressed and is believed to contribute to disease pathology," stated Maurice Zauderer, Ph.D., President and Chief Executive Officer. "As presented at the September European Huntington's Disease Network meeting, we believe post-hoc analysis of the Phase 2, SIGNAL trial of pepinemab in patients with early manifest Huntington's disease (HD) supports the potential cognitive benefit of treatment with pepinemab in HD patients, particularly those with mild advanced disease. We are engaged in discussions with potential partners for the advancement of this important program." Pepinemab Clinical Updates: Head and Neck Cancer. Enrollment is underway in the Phase 1b/2 clinical trial evaluating pepinemab in combination with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in advanced recurrent or metastatic head and neck cancer. The study will enroll up to 65 subjects across 18 U.S. trial sites and will assess whether combination therapy can improve responses in this population. Key endpoints of the study will include objective response, progression free survival and overall survival. Vaccinex anticipates data from this study in the second half of 2022.   Multiple prior studies suggest that inhibition of SEMA4D increases immune infiltration and alters the balance of cytotoxic and immunosuppressive cells in the tumor microenvironment. As SEMA4D is highly expressed in head and neck cancer, there is strong rationale for development in this indication. Alzheimer's Disease. Patient screening and enrollment have been initiated in the Phase 1/2a clinical trial of pepinemab in Alzheimer's disease. The Alzheimer's trial is being funded in part by the Alzheimer's Drug Discovery Foundation by the Alzheimer's Association under the 2020 Part the Cloud Program. The randomized, double-blind, placebo-controlled, multi-center safety and biomarker study of pepinemab in early AD is planned to enroll 40 subjects across 14 U.S. trial sites. Vaccinex anticipates topline data from this study in late 2022 or early 2023. Huntington's disease. We believe that post-hoc analysis of the Phase 2, double-blind, placebo-controlled SIGNAL trial of pepinemab in patients with early manifest Huntington's disease (HD) supports the potential cognitive benefit of treatment with pepinemab in HD patients, particularly those with mild cognitive deficits. Highly significant improvement (p=0.007) in the (Huntington's Disease Cognitive Assessment Battery (HD-CAB) Composite score, a widely employed measure comprised of 6 different cognitive assessments. Significant benefit in reducing apathy severity (p=0.017, 1-sided), a problem behavior that has previously been correlated with cognition in both HD and AD. Striking increase in brain metabolic activity as measured by FDG-PET in most brain regions. Decline in FDG-PET signal has been reported to correlate with cognitive decline in several studies of AD.    The company continues to actively explore advancing pepinemab into a Phase 3 HD trial in collaboration with a biopharmaceutical partner; discussions are ongoing. Other Trials. Pepinemab is also being evaluated in multiple investigator-sponsored trials (ISTs) being conducted by the Winship Cancer Institute of Emory University to evaluate pepinemab in combination with checkpoint inhibitors in "Window of Opportunity" studies in head and neck cancer and melanoma. Upcoming Anticipated Milestones: H2:2022– Meaningful data from open label head and neck cancer trial Late 2022/Early 2023 – Topline data from randomized Alzheimer's trial ActivMAb® Updates: As previously announced, we have entered into several collaborations with pharmaceutical and biotechnology companies employing the unique capabilities of our ActivMAb® antibody discovery platform to address difficult to drug G-protein Coupled Receptors (GPCRs) known to be strongly associated with diseases. "We believe this enabling technology will allow us and our collaborators to address significant market opportunities," said Ernest S. Smith, Ph.D., Chief Scientific Officer. Financial Results for the Three Months Ended September 30, 2021: Research and Development Expenses. Research and development expenses for the three months ended September 30, 2021 were $3.6 million as compared to $7.3 million for the comparable period in 2020. General and Administrative Expenses. General and administrative expenses for the three months ended September 30, 2021 were $1.5 million as compared to $1.9 million for the comparable period in 2020. Cash and Cash Equivalents and Marketable Securities. Cash and cash equivalents and marketable securities on September 30, 2021 were $13.8 million, as compared to $10.6 million as of December 31, 2020. About Vaccinex, Inc. Vaccinex, Inc. is pioneering a differentiated approach to treating cancer and slowly progressive neurodegenerative diseases through the inhibition of semaphorin 4D (SEMA4D). The company's lead drug candidate, pepinemab, blocks SEMA4D, a potent biological effector that prevents immune infiltration into tumors and triggers chronic inflammation in the brain. The company additionally intends to leverage its proprietary drug discovery platform, ActivMAb®, to create opportunities for future pipeline expansion and strategic collaborations, particularly by exploiting its unique capability to select high value antibodies against important multi-pass membrane receptors including GPCR and ion channels. Forward Looking Statements To the extent that statements contained in this presentation are not descriptions of historical facts regarding Vaccinex, Inc. ("Vaccinex," "we," "us," or "our"), they are forward-looking statements reflecting management's current beliefs and expectations. Such statements include, but are not limited to, statements about our plans, expectations and objectives with respect to the results and timing of our clinical trials of pepinemab in various indications, the use and potential benefits of pepinemab in Huntington's and Alzheimer's disease and other indications, and other statements identified by words such as "may," "will," "appears," "expect," "planned," "anticipate," "estimate," "intend," "hypothesis," "potential," "suggest", "advance," and similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances). Forward-looking statements involve substantial risks and uncertainties that could cause the outcome of our research and pre-clinical development programs, clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties inherent in the execution, cost and completion of preclinical and clinical trials, uncertainties related to regulatory approval, risks related to our dependence on our lead product candidate pepinemab, the impact of the COVID-19 pandemic, and other matters that could affect our development plans or the commercial potential of our product candidates. Except as required by law, we assume no obligation to update these forward-looking statements. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, see the section titled "Risk Factors" in our periodic reports filed with the Securities and Exchange Commission ("SEC") and the other risks and uncertainties described in the Company's Form 10-K for year end December 31, 2021 and subsequent filings with the SEC.                                 Investor Contact                                        John Mullaly                                        LifeSci Advisors, LLC                                617-429-3548                                        jmullaly@lifesciadvisors.com           VACCINEX, INC. Condensed Consolidated Balance Sheets (Unaudited) (in thousands, except share and per share data)     As ofSeptember 30, 2021     As ofDecember 31, 2020   ASSETS                 Current assets:                 Cash and cash equivalents   $ 13,741     $ 10,596   Accounts receivable     50       157   Prepaid expenses and other current assets     1,071       533   Total current assets     14,862       11,286   Property and equipment, net.....»»

Category: earningsSource: benzingaNov 8th, 2021

Nektar (NKTR) Q3 Earnings Top, Pipeline Remains On Track

Nektar (NKTR) reports mixed third-quarter 2021 results. The company remains on track to report top-line data from three registrational studies on bempegaldesleukin in the first half of 2022. Nektar Therapeutics NKTR reported a loss of 70 cents per share for the third quarter of 2021, narrower than the Zacks Consensus Estimate of a loss of 80 cents but wider than the year-ago loss of 61 cents.Quarterly revenues were down 17% year over year to $24.9 million during the quarter, missing the Zacks Consensus Estimate of $29.87 million. The year-over-year decline in sales was largely due to the absence of Royalty revenues.Despite the mixed quarterly results, Nektar’s shares were up 1.6% in after-hours trading on Nov 4. Shares of the company have declined 2% so far this year compared with the industry’s decrease of 13.5%.Image Source: Zacks Investment ResearchQuarter in DetailNektar’s top line comprises product sales, royalty revenues, non-cash royalty revenues along with license, collaboration and other revenues.In the third quarter, product sales decreased 8.7% from the year-ago period to $5.2 million.  Non-cash royalty revenues were $19.4 million in the quarter, up 86.3% from the year-ago quarter.License, collaboration and other revenues were $0.3 million in the quarter compared with $1.6 million in the year-ago quarter.The company did not record any Royalty revenues during the quarter as the company sold its rights to receive sales-based royalties for five partnered drugs last year.Research and development (R&D) expenses increased 3.2% to $103.7 million. General and administrative (G&A) expenses were up 9.2% year over year to $29.5 million in the reported quarter. The increase in G&A expenses was led by costs to support pre-commercialization activities related to bempegaldesleukin.Pipeline UpdateNektar remains on track with the development of its lead pipeline candidate, bempegaldesleukin, as a potential treatment for different oncology indications.Top-line data from three registrational studies evaluating bempegaldesleukin plus Opdivo in patients with melanoma, renal cell carcinoma and bladder cancer is expected in the first half of 2022. Two other registrational studies are evaluating the combination regimen as a potential treatment for urothelial cancer and adjuvant melanoma.Initial data from the phase I/II study — PROPEL — evaluating bempegaldesleukin in combination with Merck’s MRK Keytruda for treating metastatic non-small cell lung cancer is expected to presented next month at the ESMO Immuno-Oncology meeting. A phase II/III study is evaluating the combination regimen as a first-line treatment for metastatic or unresectable recurrent squamous cell carcinoma of the head and neck in patients whose tumors express PD-L1.Apart from bempegaldesleukin, Nektar is developing NKTR-255 for treating several oncology indications including non-Hodgkin lymphoma, multiple myeloma, head and neck squamous cell carcinoma and colorectal cancer in early-stage studies. The company plans to present updated data from the clinical studies evaluating NKTR-255 in solid tumors at the Society for Immunotherapy of Cancer annual meeting scheduled next week. Updated data from the hematologic malignancy studies on NKTR-255 are expected to be presented at the 2021 American Society of Hematology annual meeting next month. In September, Nektar also signed an agreement with Pfizer PFE and Germany-based Merck KGaA to evaluate NKTR-255 in combination with Pfizer/Merck KGaA’s PD-L1 inhibitor, Bavencio (avelumab) as a potential treatment of urothelial carcinoma. A combination of NKTR-255 and Bavencio will be evaluated as part of Pfizer/Merck KGaA’s phase II umbrella study — JAVELIN Bladder Medley.Nektar’s partner, Eli Lilly LLY is evaluating NKTR-358 in two mid-stage studies involving patients with lupus or ulcerative colitis. Two more mid-stage studies will be initiated to evaluate the candidate as a potential treatment for two other immune-mediated diseases.Nektar Therapeutics Price, Consensus and EPS Surprise Nektar Therapeutics price-consensus-eps-surprise-chart | Nektar Therapeutics QuoteZacks RankNektar currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Infrastructure Stock Boom to Sweep America A massive push to rebuild the crumbling U.S. infrastructure will soon be underway. It’s bipartisan, urgent, and inevitable. Trillions will be spent. Fortunes will be made. The only question is “Will you get into the right stocks early when their growth potential is greatest?” Zacks has released a Special Report to help you do just that, and today it’s free. Discover 7 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.Download FREE: How to Profit from Trillions on Spending for Infrastructure >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Pfizer Inc. (PFE): Free Stock Analysis Report Merck & Co., Inc. 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Category: topSource: zacksNov 8th, 2021

CRISPR Therapeutics (CRSP) Q3 Earnings Beat, Revenues Lag

CRISPR Therapeutics (CRSP) reports narrower-than-expected Q3 loss. Yet, revenues miss estimates for the third quarter of 2021. CRISPR Therapeutics AG CRSP reported third-quarter 2021 net loss per share of $1.67, narrower than the Zacks Consensus Estimate of a loss of $1.69 but wider than the loss of $1.32 per share in the year-ago period.CRISPR Therapeutics' total revenues, which comprise grants and collaboration revenues, came in at $0.8 million for the third quarter compared with $0.1 million reported in the year-ago quarter. The top line also substantially missed the Zacks Consensus Estimate of $3.9 million.Please note that the company is solely dependent on Vertex Pharmaceuticals VRTX for collaboration revenues.Shares of CRISPR Therapeutics have plunged 36.8% so far this year compared with the industry’s 8.2% decline.Image Source: Zacks Investment ResearchQuarter in DetailFor the reported quarter, research and development expenses were $105.3 million, up 48.3% from the year-ago figure due to increased headcount expenses and development costs for advancing the hemoglobinopathies and immuno-oncology programs.General and administrative expenses also surged 13.1% year over year to $24.4 million due to higher headcount-related costs.As of Sep 30, 2021, the company had cash, cash equivalents and marketable securities of $2.5 billion compared with $2.6 billion as of Jun 30, 2021.Pipeline UpdatesCRISPR Therapeutics is developing CTX001 — an investigational ex-vivo CRISPR gene-edited therapy for treating sickle cell disease and transfusion-dependent beta thalassemia — in partnership with Vertex. The candidate is currently in development in a phase I/II study.The company has achieved target enrollment in both the above studies and expects regulatory submission for the therapy in both indications by 2022-end.Apart from CTX001, CRISPR Therapeutics is also developing three chimeric antigen receptor T cell (CAR-T) therapy candidates — CTX110, CTX120, and CTX130 — for the treatment of hematological and solid-tumor cancers.The phase I CARBON study is evaluating the safety and efficacy of several dose levels of CTX110 for treating relapse/refractory CD19+ B-cell malignancies. Last month, it announced updated positive top-line data from the CARBON study that demonstrated the potential of CTX110 to produce durable remissions that are similar to the approved autologous CD19 CAR-T therapies on an intent-to-treat basis. Based on these results, the company plans to expand the CARBON study into a potential registrational study that is anticipated to begin consolidated dosing in first-quarter 2022.A phase I study is investigating the safety and efficacy of several dose levels of CTX120 for the treatment of relapsed or refractory multiple myeloma. Two independent ongoing phase I studies are also evaluating the safety and efficacy of several dose levels of CTX130 for treating solid tumors and certain hematologic malignancies.Based on the updated data from CTX110, the company is also implementing consolidation dosing protocols for CTX120 and CTX130. Top-line data from all these studies are now expected in first-half 2022. Earlier, the company was expected to report the data in 2021.This apart, CRISPR Therapeutics, along with partner ViaCyte, remains on track to initiate a phase I/II study on their allogeneic stem-cell-derived therapy for the treatment of type 1 diabetes later in 2021.CRISPR Therapeutics AG Price CRISPR Therapeutics AG price | CRISPR Therapeutics AG QuoteZacks Rank & Stocks to ConsiderCRISPR Therapeutics currently carries a Zacks Rank #4 (Sell).Some better-ranked stocks in the same sector include Alkermes ALKS and Regeneron Pharmaceuticals REGN, each carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.Alkermes’ earnings per share estimates for 2021 have increased from $0.61 to $0.68 in the past 60 days. The same for 2022 has risen from $1.06 to $1.11 in the past 60 days. The stock has rallied 53.5% in the year so far.Regeneron’s earnings per share estimates for 2021 have increased from $54.28 to $63.53 in the past 60 days. The same for 2022 has risen from $44.11 to $46.69 over the same period. The stock has rallied 35% in the year so far. Zacks' Top Picks to Cash in on Artificial Intelligence In 2021, this world-changing technology is projected to generate $327.5 billion in revenue. Now Shark Tank star and billionaire investor Mark Cuban says AI will create "the world's first trillionaires." Zacks' urgent special report reveals 3 AI picks investors need to know about today.See 3 Artificial Intelligence Stocks With Extreme Upside Potential>>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Regeneron Pharmaceuticals, Inc. (REGN): Free Stock Analysis Report Alkermes plc (ALKS): Free Stock Analysis Report Vertex Pharmaceuticals Incorporated (VRTX): Free Stock Analysis Report CRISPR Therapeutics AG (CRSP): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research.....»»

Category: topSource: zacksNov 4th, 2021

Clovis (CLVS) Focuses on Rubraca Growth Amid Rising Competition

Clovis Oncology's (CLVS) sole marketed drug Rubraca has been approved for multiple cancer indications. Yet, the drug's sales remain tepid on account of competition from PARP inhibitors. Clovis Oncology, Inc. CLVS has only one marketed drug in its portfolio — a PARP inhibitor, namely Rubraca (rucaparib) — that is approved for the treatment of certain patients with ovarian and prostate cancer.Currently, Rubraca is approved in the United States for two indications specific to ovarian cancer in the second- and third or later-line setting. The drug is also approved in the United States under accelerated approval as monotherapy for treating BRCA-mutant metastatic castrate-resistant prostate cancer (mCRPC).During the first half of 2021, Rubraca’s reported sales of $74.9 million were down 9.2% year over year. The decline in sales was attributed to the continuing impact of the COVID-19 pandemic.We note that though sales have been declining, Rubraca holds bright prospects for the ovarian cancer market. Clovis is also evaluating Rubraca in several label expansion studies across ovarian cancer. Rubraca is being evaluated in a phase III ATHENA study, both as a monotherapy and in combination with Bristol Myers’ BMY Opdivo in advanced ovarian cancer as a first-line maintenance treatment. Data from this study is expected in 2022.Since the drug was approved by the FDA under accelerated approval setting for mCRPC, a confirmatory phase III TRITON 3 study is evaluating Rubraca in mCRPC patients. Data from this study is anticipated in second-quarter 2022.Clovis is also conducting a head-to-head phase III CASPAR study comparing the efficacy of Rubraca plus Pfizer’s PFE Xtandi with Xtandi alone in mCRPC patients.Rubraca also has the potential to treat additional prostate, breast, pancreatic, bladder and gastroesophageal cancers. The company has also entered into collaboration with Merck MRK to develop Rubraca in combination with Keytruda for treating several cancer indications.Rubraca faces intense competition from PARP inhibitors marketed by pharma bigwigs like Merck/AstraZeneca’s Lynparza and Glaxo’s Zejula, approved for ovarian cancer. These big pharma companies have strong cash resources to promote their drugs, which can push Clovis on the back foot.We note that while the company has other candidates in its pipeline, they are all in early-stage development. It is evaluating lucitanib in early-stage clinical studies in combination with Rubraca in ovarian cancer or Opdivo in advanced gynecologic cancers and other solid tumors. FAP-2286, its peptide-targeted radionuclide therapy and imaging agent candidate, is also being evaluated across multiple tumor types in a phase I/II LuMIERE study.Clovis remains primarily reliant on a single drug for growth. A lack of candidates in mid-stage and late-stage clinical studies does not bode well for the stock. An unfavorable outcome from any of the development programs could adversely impact the company’s prospects and the stock performance. Infrastructure Stock Boom to Sweep America A massive push to rebuild the crumbling U.S. infrastructure will soon be underway. It’s bipartisan, urgent, and inevitable. Trillions will be spent. Fortunes will be made. The only question is “Will you get into the right stocks early when their growth potential is greatest?” Zacks has released a Special Report to help you do just that, and today it’s free. Discover 7 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.Download FREE: How to Profit from Trillions on Spending for Infrastructure >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Bristol Myers Squibb Company (BMY): Free Stock Analysis Report Pfizer Inc. (PFE): Free Stock Analysis Report Merck & Co., Inc. (MRK): Free Stock Analysis Report Clovis Oncology, Inc. (CLVS): Free Stock Analysis Report To read this article on Zacks.com click here......»»

Category: topSource: zacksOct 15th, 2021

Deciphera (DCPH) Thrives on Qinlock, Overdependence a Woe

Deciphera's (DCPH) Qinlock is approved for treating advanced gastrointestinal stromal tumors. The drug has seen solid uptake since its launch. Heavy dependence on Qinlock for growth remains a concern. Deciphera Pharmaceuticals, Inc.’s DCPH sole marketed drug, Qinlock, is approved for the treatment of adult patients with advanced gastrointestinal stromal tumors (“GIST”) who have received prior treatment with three or more kinase inhibitors, including Novartis’ NVS Gleevec (imatinib). The initial uptake of the drug has been strong since its approval in May 2020.The company submitted and received validation of a marketing authorization application for Qinlock in fourth-line GIST from the EMA. In September 2021, the EMA’s Committee for Medicinal Products for Human Use rendered a positive opinion, recommending approval for Qinlock to treat the given indication. A potential EMA approval is expected later in 2021.Deciphera is also working to expand the label of Qinlock in second-line GIST. A phase III study — INTRIGUE —is comparing Qinlock to Pfizer’s PFE Sutent (sunitinib) in patients with second-line GIST. Top-line results from this study are expected later in the ongoing year. The company also plans to initiate a phase I/IIb study of Qinlock in combination with Mektovi (binimetinib), an approved MEK inhibitor, to address post-imatinib GIST patients in fourth-quarter 2021. Potential label expansion of the drug can boost sales and drive growth in the days ahead.Deciphera has a diverse pipeline, and is advancing multiple drug candidates in various stages of clinical development. The company is evaluating vimseltinib for the potential treatment of tenosynovial giant cell tumor. The company is also developing rebastinib, which is being studied in two phase Ib/II studies in combination with chemotherapy.Deciphera is evaluating its investigational ULK kinase inhibitor, DCC-3116, in a phase I study, to treat patients with advanced/metastatic tumors driven by mutations in RAS/RAF genes. The study is investigating DCC-3116 as a single agent and also in combination with Mekinist (trametinib), an FDA-approved MEK inhibitor.We note that Deciphera currently has only one approved product in its portfolio — Qinlock. This apart, all of its drug candidates, including vimseltinib, rebastinib and DCC-3116, are still in early stages of development. Hence, any regulatory setback for the candidates will be a setback for the company. Qinlock faces competition from Blueprint Medicines’ BPMC Ayvakit, which is approved for the treatment of unresectable or metastatic GIST, harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations in adults. Several other companies are also developing drugs for the treatment of GIST. This too remains an overhang. Infrastructure Stock Boom to Sweep America A massive push to rebuild the crumbling U.S. infrastructure will soon be underway. It’s bipartisan, urgent, and inevitable. Trillions will be spent. Fortunes will be made. The only question is “Will you get into the right stocks early when their growth potential is greatest?” Zacks has released a Special Report to help you do just that, and today it’s free. Discover 7 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.Download FREE: How to Profit from Trillions on Spending for Infrastructure >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Novartis AG (NVS): Free Stock Analysis Report Pfizer Inc. (PFE): Free Stock Analysis Report Blueprint Medicines Corporation (BPMC): Free Stock Analysis Report Deciphera Pharmaceuticals, Inc. (DCPH): Free Stock Analysis Report To read this article on Zacks.com click here......»»

Category: topSource: zacksOct 15th, 2021

Allogene (ALLO) Falls on FDA Clinical Hold on CAR-T Studies

The FDA places Allogene's (ALLO) clinical studies evaluating AlloCAR T therapy candidates on hold, following chromosomal abnormality observed in an early-stage study patient receiving ALLO-501A. Allogene Therapeutics, Inc. ALLO announced that the FDA has placed its clinical studies evaluating AlloCAR T-based cancer therapies on clinical hold. The decision was taken by the regulatory authority, following a report of a chromosomal abnormality with unclear clinical significance in a patient in the phase I/II study — ALPHA2 — evaluating its next-generation, AlloCAR T candidate, ALLO-501A.The FDA is currently reviewing the end of phase I materials submitted by the company to support the start of a pivotal phase II study on ALLO-501A. Meanwhile, the company is investigating the abnormality for further evidence of clinical relevance, evidence of clonal expansion, or potential relationship to gene editing. The company expects to provide additional updates from the study, especially on this abnormality, in the upcoming weeks, following consultation with the FDA.Allogene is developing a pipeline of off-the-shelf T cell product candidates that are designed to target and kill cancer cells. It has a deep pipeline of allogeneic chimeric antigen receptor (CAR) T cell product candidates targeting multiple promising antigens in a host of hematological malignancies and solid tumors. The FDA’s clinical hold should temporarily halt all its ongoing clinical studies, hurting the company’s prospects.The clinical hold hurt investors’ sentiments that led to a decline of 32.7% in Allogene’s share price during after-hours trading on Oct 7. The company’s shares have declined 3.4% so far this year compared with the industry’s decrease of 12%.Image Source: Zacks Investment ResearchThe clinical hold was based on a single case in the ALPHA2 study in a patient with stage IV transformed follicular lymphoma whose disease was refractory to two prior lines of immune-chemotherapy and additional radiation therapy. Moreover, the patient was not able to receive an autologous CD19 CAR T cell therapy due to some manufacturing failure.The company reported that the patient experienced complications following the administration of ALLO-501A, which required a course of high-dose steroid therapy. The patient developed progressive pancytopenia or low blood count subsequently. The company did a bone marrow biopsy and found the patient suffering from aplastic anemia and also detected the presence of ALLO-501A CAR T cells with the chromosomal abnormality. However, the company stated that the patient has achieved a partial response to the AlloCAR T therapy.Apart from ALLO-501A, the company has three other AlloCAR T- based therapy candidates in its internal pipeline evaluating them in hematologic cancers. The company is sponsoring a phase I study (the ALPHA trial) of ALLO-501 in patients with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL). The company continues to advance the phase I study (the TRAVERSE trial) of ALLO-316, an allogeneic CAR T cell product candidate targeting CD70, in adult patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC). A phase I study, UNIVERSAL, is underway. The study is evaluating ALLO-715 as a monotherapy and in combination with nirogacestat, SpringWorks Therapeutics’ SWTX investigational gamma secretase inhibitor.While the CAR T space holds promise competition is stiff.  Earlier in the year, the FDA approved bluebird bio BLUE/Bristol Myers Squibb’s BMY CAR T cell immunotherapy, Abecma. Other approved CAR T cell therapies in the United States included Gilead’s Yescarta and Novartis’ Kymriah.Allogene Therapeutics, Inc. Price Allogene Therapeutics, Inc. price | Allogene Therapeutics, Inc. QuoteZacks RankAllogene currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Infrastructure Stock Boom to Sweep America A massive push to rebuild the crumbling U.S. infrastructure will soon be underway. It’s bipartisan, urgent, and inevitable. Trillions will be spent. Fortunes will be made. The only question is “Will you get into the right stocks early when their growth potential is greatest?” Zacks has released a Special Report to help you do just that, and today it’s free. Discover 7 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.Download FREE: How to Profit from Trillions on Spending for Infrastructure >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Bristol Myers Squibb Company (BMY): Free Stock Analysis Report bluebird bio, Inc. (BLUE): Free Stock Analysis Report Allogene Therapeutics, Inc. (ALLO): Free Stock Analysis Report SpringWorks Therapeutics Inc. (SWTX): Free Stock Analysis Report To read this article on Zacks.com click here......»»

Category: topSource: zacksOct 8th, 2021