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  • FDA review flags limited efficacy of Revolution's pancreatic cancer drug Rasonque, shares drop 6%
    Shares of Revolution Medicines fell about 6% after the Food and Drug Administration released review documents that suggest its pancreatic cancer therapy Rasonque may not work as well in all patient…
    BioPharma Dive · 11d agoRegulatoryNegative↗ source
  • RevMed's Rasonque shows weaker response in common KRAS pancreatic cancer mutation, shares fall over 6%
    New data from Revolution Medicines indicates that its KRAS inhibitor Rasonque had a reduced response rate in patients whose pancreatic tumors carry the most common KRAS mutation. The subgroup resp…
    Endpoints · 11d agoNegative readoutNegative↗ source
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  • Biotech Index Retraces Gains as Weak Trial Data and Market Fears Weigh
    BioPharma Dive’s latest data‑visualization piece examines why biotech stocks have slipped recently and highlights the rapid pace of startup acquisitions this year. The XBI index, a barometer for b…
    BioPharma Dive · 12d agoNeutral↗ source
  • CBER Director Karim Mikhail Aims to Restore Stability After Turbulent Leadership Changes
    The FDA's Center for Biologics Evaluation and Research (CBER) is working to regain stability after a period of rapid leadership turnover. Karim Mikhail, who was confirmed as the permanent director…
    Fierce Biotech · 12d agoRegulatoryPositive↗ source
  • AI startup Chai Discovery inks GSK deal to develop biologics using artificial intelligence
    Chai Discovery, an artificial‑intelligence focused biotech, has signed a collaboration agreement with GlaxoSmithKline to create biologic medicines using its AI platform. The partnership will lever…
    Endpoints · 12d agoDealPositive↗ source
  • GSK partners with Chai Discovery to use AI protein-folding models after successful wet-lab tests
    GSK has entered a collaboration with Chai Discovery, a biotech firm that offers AI‑driven protein folding and design tools. The agreement gives GSK access to Chai's models, which were reported to…
    Fierce Biotech · 12d agoDealPositive↗ source
  • Pfizer signs $500M deal with Enodia to develop Sec61 protein degraders
    Pfizer has entered a licensing and research collaboration with Enodia Therapeutics, valued at up to $500 million, to discover and develop inhibitors of the Sec61 protein‑translocation channel. The…
    Fierce Biotech · 12d agoDealNeutral↗ source
  • TRexBio raises $117 million in IPO as Retension secures $45 million Nasdaq debut for hypertension therapy
    TRexBio completed its initial public offering on Thursday, pricing the shares at a level that generated about $116.7 million in gross proceeds. The funding will support the company’s development of…
    Endpoints · 12d agoDealPositive↗ source
  • Fierce Biotech outlines criteria for its 2026 Fierce 15 list, spotlighting top innovators
    The Fierce Biotech editorial team released its 2026 Fierce 15 list and discussed the selection process on a recent episode of "The Top Line" podcast. More than 150 high‑quality entries were review…
    Fierce Biotech · 12d agoPositive↗ source
  • Nobel-winning optogenetics sees growing biotech interest
    Karl Deisseroth, a Stanford psychiatrist and bioengineer, learned he had shared the 2026 Nobel Prize in Physiology or Medicine for pioneering optogenetics, a method that makes neurons responsive to…
    Fierce Biotech · 12d agoPositive↗ source
  • TRex Bio prices $117M IPO to fund Treg-targeted immune therapies
    TRex Bio announced pricing of its initial public offering at $117 million, selling 8,333,334 shares at $14 each, meeting the low end of its earlier guidance. The company will begin trading on Nasd…
    BioPharma Dive · 12d agoDealPositive↗ source
  • City Therapeutics plans $158 million IPO as Iambic eyes $135 million Nasdaq debut
    City Therapeutics, an RNAi startup founded by former Alnylam Pharmaceuticals executives, announced plans for an initial public offering targeting roughly $158 million. The company intends to sell a…
    Endpoints · 12d agoDealNeutral↗ source
  • BD appoints Ferass Abuzaina as Worldwide President of Surgery
    Becton, Dickinson and Company announced that Ferass Abuzaina will serve as the new Worldwide President of its Surgery business unit, effective immediately. He will oversee the global strategy, oper…
    Fierce Biotech · 12d agoPositive↗ source
  • FDA issues early alert on Philips Lumify ultrasound system software and connection problems
    The FDA’s Center for Devices and Radiological Health has released an Early Alert about a potential high‑risk issue with Philips Lumify diagnostic ultrasound devices. The problem involves either a s…
    fda medwatch · 12d agoRegulatoryNegative↗ source
  • Curium lists Bexlutry at $63,524 per infusion, roughly 5% cheaper than Novartis' Lutathera
    Curium announced the list price for its radioligand Bexlutry, a generic version of Novartis' Lutathera. The price is set at $63,524 per infusion, which represents about a five percent discount com…
    Endpoints · 11d agoNeutral↗ source
  • Viking Therapeutics commercial chief exits after nine months; Gilead eyes BeOne executive for China growth
    Viking Therapeutics' chief commercial officer Neil Aubuchon left the company after only nine months in the role, according to Peer Review. His brief tenure has sparked speculation about the compan…
    Endpoints · 12d agoNeutral↗ source
  • Acting HHS General Counsel Bob Foster Departs Agency
    The acting general counsel for the U.S. Department of Health and Human Services, Bob Foster, is no longer employed by the agency. Endpoints News attempted to reach him via his government email and…
    Endpoints · 11d agoRegulatoryNeutral↗ source
  • Endeavor BioMedicines reports positive phase 2b results for Hedgehog inhibitor taladegib in IPF
    Endeavor BioMedicines announced that its Hedgehog pathway inhibitor, taladegib, produced encouraging results in a phase 2b study of patients with idiopathic pulmonary fibrosis (IPF). The trial, nam…
    Fierce Biotech · 13d agoPositive readoutPositive↗ source
  • Argenx shares tumble 15% after Phase 3 Sjögren’s study of Vyvgart halted for futility
    Argenx reported that an independent monitoring board recommended stopping its Phase 3 trial of Vyvgart in Sjögren’s disease due to futility, based on an interim analysis. The decision came earlier…
    BioPharma Dive · 12d agoNegative readoutNegative↗ source
  • Argenx halts Phase 3 Sjögren's trial as celiac disease data brings mixed results
    Argenx disclosed on Thursday that it is ending its Phase 3 trial in Sjögren's syndrome after the study failed to meet its primary endpoint. The decision came alongside the release of encouraging r…
    Endpoints · 13d agoNegative readoutNegative↗ source
  • Viatris to acquire Pacira BioSciences for $1.65 billion, expanding its non‑opioid pain portfolio
    Viatris, a maker of generic and branded medicines, announced a cash purchase of commercial‑stage Pacira BioSciences for $1.65 billion. The deal adds Pacira’s non‑opioid pain treatments to Viatris’…
    Endpoints · 12d agoDealPositive↗ source
  • Viatris to acquire Pacira BioSciences for $1.65 billion, adding two non-opioid pain drugs
    Viatris announced Thursday it will purchase Pacira BioSciences for $1.65 billion in cash, paying $36.50 per share, a 45% premium to the prior close. The acquisition gives Viatris control of Pacira…
    BioPharma Dive · 12d agoDealPositive↗ source
  • Ono Pharmaceutical pays Biohaven $80 million for protein degrader as UK pulls Valneva's chikungunya vaccine
    Tokyo-based Ono Pharmaceutical announced it will pay Biohaven $80 million upfront to license a pan‑IgG protein degrader technology. The agreement gives Ono rights to develop the degrader, while Bi…
    Endpoints · 12d agoDealNeutral↗ source
  • Endeavor BioMedicines reports mid-stage trial success for IPF drug, suggests disease reversal potential
    Endeavor BioMedicines announced that its experimental therapy for idiopathic pulmonary fibrosis has met its primary goals in a Phase 2 study. The company said the mid‑stage trial showed signs that…
    Endpoints · 12d agoPositive readoutPositive↗ source
  • Zealand and Roche report positive Phase 2 results for amylin drug petrelintide in obesity and diabetes
    Zealand Pharma and Roche announced topline results from a Phase 2 trial of their amylin analogue petrelintide in patients with obesity and type 2 diabetes. The interim data showed that participant…
    Endpoints · 12d agoPositive readoutPositive↗ source