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Neurocrine culls Phase 2 neuropsych med after failing to validate earlier data
Neurocrine is halting further development of luvadaxistat after it failed to improve cognitive impairment in patients with schizophrenia in a mid-stage study. The company said in a Thursday update that...
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Oncternal stops cancer trials and begins search for future business options
After disappointing efficacy data and a patient death, Oncternal Therapeutics is discontinuing two trials and looking for strategic alternatives. The San Diego company said it would end a Phase 1 trial...
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Doug Williams returns with a ‘FIT’ bet on CAR-Ts; Biogen appoints Mene...
Doug Williams Industry veteran Doug Williams is back with a new approach to CAR-T cell therapies that he expects to take into the clinic in the US by year’s end. After a brief stint at Sana...
View ArticleValneva raises about €61M; Immuneering details new Phase 2a data
Plus, news about ONL Therapeutics, Cidara Therapeutics, Emergent BioSolutions, Vico Therapeutics and Centessa: Valneva gets €61.2M private placement: Valneva said the funds will go toward supporting...
View ArticleOnline stimulant prescriptions soared during Covid pandemic, study finds
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Stimulants prescribed during telehealth visits rose dramatically during the Covid-19 pandemic, when...
View ArticleWHO pre-qualifies Bavarian Nordic’s vaccine as first mpox shot
Bavarian Nordic has secured the first mpox vaccine pre-qualification from the World Health Organization since the disease outbreak was declared an emergency a month ago. The vaccine, dubbed MVA-BN, is...
View ArticleFDA approves subcutaneous Ocrevus, broadening access to Roche and Genentech...
The FDA on Friday approved a new formulation of Roche and Genentech’s multiple sclerosis drug Ocrevus in what they hope will broadly expand access to the treatment. Patients will now be able to take...
View ArticleAurinia restructures board, bringing in Kevin Tang and keeping CEO
Aurinia Pharmaceuticals offered an olive branch to a group of shareholders clamoring for change. It’s shrinking its board by two seats, and it added activist investor Kevin Tang. CEO Peter Greenleaf...
View ArticleAtea ends development of inhibitor candidate as Covid-19 treatment following...
Viral disease-focused biotech Atea Pharmaceuticals announced a late-stage trial failure for its nucleotide polymerase inhibitor, which it was investigating as a Covid-19 treatment. The Phase 3...
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Post-Hoc: Big promises built Moderna. They might also be its undoing
(This is a preview of Post-Hoc, our latest newsletter with analysis and dispatches from our journalists. To sign up for future editions, click here.) One of my distinct memories of the early pandemic...
View ArticleAfter a huge IPO and acquisition, Zymergen caps off bankruptcy with $30M SEC...
The rise and fall of the short-lived biotech Zymergen has ended with a $30 million penalty from the SEC. Zymergen’s rise began in April 2021 with an outsized $500 million IPO, capping a remarkable run...
View ArticleArbor Biotechnologies cuts early-stage discovery work, lays off staff
Arbor Biotechnologies is trimming its early-stage discovery work, leading to layoffs in the group. The move was confirmed by an Arbor spokesperson, with CEO Devyn Smith saying in a statement to...
View ArticleAdcomm says Intercept's rare liver disease drug should not get full approval
An FDA advisory committee recommended against full approval for Alfasigma and Intercept Pharmaceuticals’ rare liver disease drug Ocaliva by a 13-1 vote, concluding that confirmatory evidence didn’t...
View ArticleSEC probe of Illumina’s Grail deal targets sales forecasts, sources say
The SEC’s investigation into the $8 billion deal between Grail and Illumina is examining sales forecasts made by Grail’s management in the run-up to the 2021 transaction, according to sources familiar...
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#ESMO24: GSK, iTeos rejuvenate struggling TIGIT space with positive Phase 2...
BARCELONA — GSK and iTeos have unveiled positive mid-phase data for their PD-1 plus TIGIT doublet in certain lung cancer patients, bolstering expectations for an ongoing Phase 3 trial that is testing...
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#ESMO24: Nuvation Bio outlines pooled data for former AnHeart drug in...
Nuvation Bio outlined pooled data from its two Phase 2 studies at the annual European Society for Medical Oncology confab in Barcelona this weekend as it prepares to approach the FDA soon. The company...
View ArticleHouse passes Biosecure Act; Moderna outlines more cost cuts; What's happening...
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...
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#ESMO24: Bristol Myers touts LAG-3 strategy in lung cancer as it preps for...
BARCELONA — Bristol Myers Squibb’s LAG-3 approach has shown potential in certain lung cancer patients in a Phase 2 study, drawing some reassurance in its planned late-stage trial against Merck’s...
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#ESMO24: Pfizer tees up Phase 3 in 2025 in weight management, but in an...
BARCELONA — At a major cancer conference, Pfizer made an unexpected announcement: It has late-stage plans in weight management. But it’s not targeting weight loss like one would first think amid the...
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#ESMO24: Incyte gears up to face FDA once again with more Zynyz data in rare...
BARCELONA — Incyte said it has positive late-phase results for its PD-1 drug Zynyz in certain patients with squamous cell carcinoma, three years after the FDA asked for more data. The Phase 3...
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