Gilead deepens its stake in Assembly Biosciences; NGM licenses out MASH drug
Plus, news about Abilita Therapeutics, Orion, Novartis, XGEN Venture, Palleon, Henlius, TigaTx, HERVolution Therapeutics and Krystal Biotech: Gilead now owns 30% of Assembly Biosciences: The drugmaker...
View ArticleWhat health tech startups can expect in 2025
This week, Shelby and I looked at the state of health tech funding as we head into next year. In our conversations with investors and bankers, we found some cautious ...
View ArticleRegeneron forges ahead in factor XI despite field’s mixed results
Regeneron will start a “broad” Phase 3 program next year for its two factor XI antibodies, following open-label Phase 2 results for the experimental anti-clotting drugs. The company
View ArticlePayers generally meet drug price watchdog's 'fair access' standards, report says
The Institute for Clinical and Economic Review said major insurers’ drug coverage policies generally do align with the pricing watchdog's set of "fair access" standards, according to a report released...
View ArticleMesoblast wins long-awaited approval for cell therapy
Mesoblast’s stock surged on Thursday after the company won FDA approval for its twice-rejected graft-versus-host disease therapy. Remestemcel-L is the first mesenchymal stromal cell therapy to be...
View ArticleXcovery nabs first FDA approval for lung cancer drug
The FDA has approved Xcovery Holdings' ALK inhibitor Ensacove for first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung...
View ArticleFDA rejects Zealand Pharma's short bowel syndrome drug
The FDA rejected Zealand Pharma’s short bowel syndrome drug, and asked the company to run another trial before it reconsiders. The FDA told Zealand it wanted an additional test to “provide further...
View ArticleFDA approves Ionis’ treatment for a rare metabolic disorder
Ionis’ antisense oligonucleotide olezarsen is now the first approved treatment for familial chylomicronemia syndrome, a rare metabolic disorder that prevents the body from breaking down fats called...
View ArticleNovo’s 23% weight loss with CagriSema falls short of high expectations
Novo Nordisk said its highly anticipated Phase 3 readout showed that CagriSema only managed 22.7% weight loss, failing to hit the 25% benchmark the company, investors and analysts were seeking. The...
View ArticleFlorida cancer biotech Syncromune raises $100M Series A
Syncromune, a biotech startup working on combination immunotherapies, has put together a $100 million Series A, the company told Endpoints News. The round was led by a new, undisclosed institutional...
View ArticleAadi starts from scratch as it sells assets, licenses ADCs and raises new funds
In a major reset to round off the year, Aadi Bioscience is divesting its only marketed product and in-licensing a trio of ADCs developed by WuXi Biologics and another Chinese biotech. Aadi has inked an...
View ArticleDaiichi Sankyo finds successor to late R&D exec; Versant, Novartis' kidney...
→ Yuki Abe will step in to replace the late Toshinori Agatsuma on Jan. 1 as head of the R&D division at Daiichi Sankyo and VP of its ...
View ArticleTracer Biotechnologies raises $10M, partners with AstraZeneca
Tracer Biotechnologies has raised a $10 million Series A round to advance its technology that's designed to monitor circulating tumor DNA in cancer patients over lengthy periods. The company uses...
View ArticleCommure's latest acquisition sends follow up texts to patients
General Catalyst-backed Commure is buying another General Catalyst-backed startup that sends follow-up texts to patients. Commure, which was valued at over $6 billion after merging with General...
View ArticleIdorsia’s Tryvio deal delay; Galectin’s liver drug disappoints
Plus, news about Pyxis, Epitopea and Genevant: Idorsia’s deal for blood pressure drug hits snag: The Swiss company said negotiations with an unnamed party for
View ArticleApplied Therapeutics CEO steps down after rare disease drug rejection
Applied Therapeutics is making changes to its leadership less than a month after the FDA rejected its rare disease drug. Shoshana Shendelman is stepping down from her roles as CEO and chair of the...
View ArticleSofinnova outlines $550M fund after IPOs and M&A deals
Sofinnova Investments, one of the longest-standing biotech investment firms, has penciled in plans for a new $550 million fund, Endpoints News has learned. The Menlo Park, CA-based firm disclosed the...
View ArticleGSK's Zejula-Jemperli combo in ovarian cancer hits primary endpoint, misses...
GSK’s Zejula-Jemperli combo met its primary endpoint in a trial investigating the drugs in first-line advanced ovarian cancer, but missed on a key secondary endpoint. The company shared topline results...
View ArticleFDA approves Humacyte’s lab-grown blood vessels
Twenty years ago, Laura Niklason founded a company that sounded like something out of science fiction. The Duke University bioengineer and anesthesiologist was working in the budding field of...
View ArticleRhythm receives expanded approval for genetic obesity drug
Rhythm Pharmaceuticals received FDA approval to market its genetic obesity drug Imcivree for children as young as 2 years old. Friday's action will let the drug be used to treat excess body weight and...
View ArticleFDA's Califf predicts Ramaswamy-RFK battle over agency
FDA Commissioner Rob Califf has only a few weeks left before he steps down with the change in administrations. But he recently predicted that the next person to head the agency will face a ...
View ArticleAccelerated approval brings Pfizer's BRAF inhibitor to first-line patients
Pfizer scored an accelerated approval Friday to bring its BRAF inhibitor to first-line colorectal cancer patients. Braftovi was approved in combination with cetuximab, also known as Eli Lilly’s...
View ArticlePBM changes unlikely to join spending bill as shutdown looms
With the federal government staring down a midnight deadline that could lead to the furlough more than 40,000 staff at the Department of Health and Human Services, several significant healthcare...
View Article2024's biopharma winners and losers; CagriSema falls short; Merck swings...
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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