FDA authorizes Novavax Covid booster; Recursion nears key data readouts;...
Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add...
View ArticleBayer’s Kerendia cuts heart death, failure and hospitalization by 16% in...
Less than a month after announcing success in a late-phase trial, Bayer has unveiled detailed results from its drug Kerendia in a subset of people with heart failure, sparking plans for a regulatory...
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Sanofi’s BTK inhibitor goes 1-for-3 in key MS trials, slows disability...
The potential of Sanofi’s closely-watched BTK inhibitor in multiple sclerosis is coming into clearer view, amid plans to narrow the focus of the French company’s business drug development and get out...
View ArticleArrowhead spotlights key pancreatitis figures from Phase 3 lipid disease...
Arrowhead Pharmaceuticals has unveiled highly anticipated pancreatitis results from a late-phase trial of plozasiran for a rare lipid disorder, several months after reporting topline data. Arrowhead...
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Exclusive: Duke spinout launches in hopes of prevailing with brain cancer...
Adaptin Bio is launching with plans to bring a bispecific T cell engager for glioblastoma, a deadly form of brain cancer, into the clinic. The company received FDA clearance to start its clinical...
View ArticleUpdated: Vaxcyte surges on Phase 1/2 data for 31-valent pneumococcal vaccine
Vaxcyte shares $PCVX jumped more than 40% Tuesday morning on the heels of Phase 1/2 data for its 31-valent pneumococcal conjugate vaccine, VAX-31, being tested in adults over 50. The company tested...
View ArticleExclusive: PatientPartner raises $7M to help pharma companies match patients...
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) PatientPartner, a startup that matches patients with mentors who’ve gone through similar medical...
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AI-focused biotech Recursion underwhelms with first Phase 2 readout
Recursion reported mixed data Tuesday from its first Phase 2 study, in a disappointing start to an expected frenzy of clinical results. The Salt Lake City-based biotech has forecast a stretch of about...
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ProKidney axes one Phase 3 study, aims for 'expedited approval pathway' using...
ProKidney believes it will only need one Phase 3 trial to win an FDA approval for its kidney disease cell therapy, and will discontinue another to save cash. On Tuesday, the biotech said it will wind...
View ArticleDenali details accelerated approval plans; Jazz's $850M private offering
Plus, more news about Circle Pharma, Emergent, Cytokinetics, Nxera Pharma, Neurocrine Biosciences, Simcere Zaiming, TargetRx and Calliditas: Denali Therapeutics to seek accelerated approval in 2025:...
View ArticlePraxis' epilepsy drug reduces seizures by 46% in pediatric patients in Phase...
Praxis Precision Medicines released another batch of topline data from its epilepsy program on Tuesday, this time from the Phase 2 EMBOLD study investigating relutrigine in SCN2A and SCN8A...
View ArticleNovo Nordisk continues to grapple with patchy GLP-1 drug supply in Europe
All doses of Novo Nordisk’s Ozempic are expected to face “intermittent shortages” in Europe during the fourth quarter of the year, especially lower doses, supplies of which have “deteriorated,”...
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Three Dyne executives leave as company reports new Duchenne drug data
Dyne Therapeutics’ new data on its experimental Duchenne muscular dystrophy drug is being overshadowed by the departure of several top executives. The biotech announced Tuesday that its chief operating...
View ArticleEuropean Commission revokes Ocaliva's authorization ahead of FDA adcomm
Advanz Pharma on Tuesday said its liver disease treatment Ocaliva suffered a setback as the European Commission revoked its conditional marketing authorization. Ocaliva, which was available in Europe...
View ArticleDana-Farber chief Laurie Glimcher set to leave storied cancer center
After eight years, Laurie Glimcher will step down as president and CEO of the Dana-Farber Cancer Institute, Boston’s famed oncology research center. Replacing her on Oct. 1 is Benjamin Ebert, chair of...
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Pfizer and Valneva say second Lyme booster led to 'strong' responses, target...
Pfizer and Valneva said patients demonstrated “strong immune responses” after receiving a second booster dose of their experimental Lyme disease vaccine, supporting the case for annual dosing. Patients...
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Court's ruling on Illumina-Grail deal could signal a limit to European...
Illumina’s legal victory against the European Union’s antitrust enforcer won’t give the testing company back its $7.1 billion merger with Grail. But it might dampen the bloc’s more aggressive antitrust...
View ArticleResearchers seek answers as they spell out Phase 3 failure of Bayer’s...
Researchers reported Sunday that atrial fibrillation patients who received Bayer’s experimental anticoagulant were significantly more likely to experience a stroke or systemic embolism compared to...
View ArticleBioAge files for IPO, riding momentum for weight loss drugs
BioAge Labs is heading to Wall Street after months of speculation that the Eli Lilly-partnered cardiometabolic biotech was planning to join the public markets. The company’s investor prospectus...
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Athira’s small molecule drug for Alzheimer’s fails in mid-stage study
A daily injection intended to protect and regenerate brain cells has failed to slow the progression of Alzheimer’s disease in a Phase 2/3 clinical trial run by Athira Pharma, the company announced...
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