Earnings season continues; FDA delays PDUFA date; AACR recap; and more
Welcome back to Endpoints Weekly, our roundup of the top headlines in biopharma. Earnings season continued this week, with more comments from pharma executives on the potential impact of tariffs, new...
View ArticleTopas claims success in early test of 'immune tolerance' celiac therapy
Topas Therapeutics, a small German biotech company attempting to quell overactive immune systems, has revealed the first data from a study of its “tolerance induction” therapy for celiac disease. The...
View ArticleEarly in vivo CAR-T human data emerge from biotech trials in China
The first shards of human data on in vivo CAR-T cell therapy look promising, based on recent separate reports from two biotech companies’ academic-led studies in China. Last week, a Chinese startup...
View ArticleThe big question for the FDA after Stealth’s PDUFA delay
Is the PDUFA delay for Stealth BioTherapeutics a canary-in-the-coalmine moment? Or is it an overblown one-off that signals little about disruption at the FDA? That’s the question seemingly on...
View ArticleDeerfield secures $600M+ for third healthcare venture fund to seed new companies
Deerfield Management is back with its third healthcare venture fund, this time securing more than $600 million to create new drug development outfits, medical technology startups and adjacent...
View ArticleAI biotech Iambic debuts next-gen model Enchant for drug R&D
Iambic Therapeutics claims that it has improved the predictive power of its AI model Enchant by scaling it up, in what one of the company’s co-founders says is a “material shift” for its drug discovery...
View ArticleJ&J eye disease gene therapy bota-vec fails Phase 3
Johnson & Johnson’s gene therapy for a genetic disease that leads to vision loss called X-linked retinitis pigmentosa (XLRP) failed a pivotal trial, according to an update to a J&J healthcare...
View ArticleUnity lays off 'all' workers; Novo to get FDA decision on oral Wegovy this year
Plus, news about ImmunityBio and Inventiva: Unity Biotechnology shelves work: The anti-aging drug developer plans to evaluate strategic alternatives and conduct layoffs that affect “all of its...
View ArticleAI biotech Recursion cuts pipeline to 'sharpen focus'
Recursion's leaders tried to make the case last year that the company had avoided the fate of some of its AI-focused peers, which had seen their first clinical programs fizzle out. The Salt Lake City ...
View ArticleFunction buys Ezra, combining preventive testing and scans
Function Health is buying Ezra in a bid to create a haven for people who want copious amounts of data on their bodies. The combined company will be a one-stop shop for preventive lab testing ...
View ArticleBioNTech doesn't see ‘near-term’ impact from RFK Jr.'s vaccine policy proposal
A proposal by HHS Secretary Robert F. Kennedy Jr. to change the approval standard of new vaccines shouldn't affect BioNTech's Covid-19 franchise, the company told investors Monday. Biotech and pharma...
View ArticleBristol Myers to lay off over 500 workers in New Jersey
Bristol Myers Squibb is letting go of 516 workers in New Jersey as part of a wide-reaching cost-cutting plan aimed at making the drugmaker more efficient. The company, based in Princeton, NJ, first...
View ArticlePTC's Huntington’s study succeeds, but accelerated approval uncertain
PTC Therapeutics announced Monday that its splicing drug for Huntington’s disease met the primary endpoint of a Phase 2 study, but stopped short of spelling out the important data that could ...
View ArticleFDA adcomm to review Capricor's Duchenne cell therapy
Capricor Therapeutics' cell therapy for Duchenne muscular dystrophy will face an FDA advisory committee ahead of an approval decision that's expected Aug. 31, the company disclosed on Monday. The San...
View ArticleNew opioid data may not be generalizable, FDA adcomm says
Several members of an FDA advisory committee warned on Monday that new data from studies on long-term use of opioids might underestimate the harms from their misuse and abuse. The committee reviewed...
View ArticleVertex touts promising launch for non-opioid pain drug Journavx
Vertex said it's gathering momentum with its new product launches, building out new franchises with its sickle cell therapy Casgevy, another cystic fibrosis drug in Alyftrek, and the non-opioid pain...
View ArticleSingapore cardio gene therapy biotech collects $45M as it plots Europe expansion
A Singapore-based startup raised a $45 million Series B to start testing a gene therapy in humans next year for a genetic heart muscle disorder, signaling that the AAV-based gene therapy field still...
View ArticleAldeyra plots third FDA filing for dry eye disease drug after latest Phase 3...
Aldeyra Therapeutics isn’t giving up on its drug candidate for dry eye disease despite a challenging path so far. The company is preparing to file reproxalap with the FDA for the third time after a ...
View ArticleDegradation startup raises $39M for pivot to PROTACs and clinical entry
PAQ Therapeutics has taken a new direction. The startup shifted its protein degradation approach to the more common PROTAC lane, pivoted to cancer, hired a chief medical officer from Frontier...
View ArticleLilly to pay up to $415M in ALS deal; Actuate’s mid-stage pancreatic cancer data
Plus, news about Atara Biotherapeutics, Immutep, bluebird bio, OSE Immunotherapeutics, Mersana Therapeutics, Innovent, Biomea Fusion and Trailhead Biosystems: Eli Lilly does another ALS deal: The...
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