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  • Bayer's asundexian receives FDA approval for stroke prevention
    Bayer announced that the U.S. Food and Drug Administration has approved its oral anticoagulant asundexian for stroke prevention. The drug is indicated to lower the risk of subsequent stroke in pati…
    Endpoints · 16h agoApprovalPositive↗ source
  • AstraZeneca acquires Omniose to boost bacterial vaccine capabilities
    AstraZeneca has completed the purchase of Omniose, a specialist in vaccine bioconjugation, making the company a wholly owned subsidiary of its infectious disease division. The two firms began coll…
    Fierce Biotech · 6h agoDealPositive↗ source
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  • Mirum's hepatitis D antibody brelovitug meets primary endpoint in phase 3 trial
    Mirum Pharmaceuticals announced that its experimental antiviral monoclonal antibody brelovitug achieved the primary efficacy goal in a phase 3 study for hepatitis D. The trial results continue a s…
    Fierce Biotech · 7h agoPositive readoutPositive↗ source
  • PepGen's Phase 2 DM1 Data Show 46% Average Splicing Correction, Shares Jump 163%
    PepGen reported results from the 10 mg/kg multiple‑ascending‑dose cohort of its ongoing Phase 2 Freedom2‑DM1 trial, testing PGN‑EDODM1, an oligonucleotide designed to correct the molecular defect i…
    Fierce Biotech · 6h agoPositive readoutPositive↗ source
  • London startup Oyster Therapeutics raises $60M to develop oral tau degraders for Alzheimer’s
    Oyster Therapeutics, a London‑based biotech, announced it has closed a $60 million Series A‑2 financing round. The round was led by 4BIO Capital, a life‑science venture capital firm, with addition…
    Endpoints · 9h agoDealPositive↗ source
  • White House pushes Heidi Overton nomination for FDA commissioner as confirmation window narrows
    The White House is actively promoting Heidi Overton's nomination to become the commissioner of the Food and Drug Administration. Administration officials are working to gather sufficient Senate su…
    Endpoints · 1h agoRegulatoryNeutral↗ source
  • AbCellera halts development of OX40 antibody ABCL575 after phase-1 trial
    AbCellera announced it will not move ABCL575 beyond phase 1, ending its OX40 program. The phase-1 study met its endpoints, showing a favorable tolerability profile and pharmacokinetics that suppor…
    Fierce Biotech · 11h agoNegative↗ source
  • Coherus Oncology cuts 30% of staff to focus on esophageal cancer combo
    Coherus Oncology announced another round of layoffs, reducing its workforce by about 30% as it narrows its development program. The cuts follow the presentation of phase 1b data on a combination o…
    Fierce Biotech · 13h agoLayoffsNeutral↗ source
  • OpenAI’s health chief envisions ChatGPT Health moving patients from answers to actionable steps
    Nate Gross, who leads the health division at OpenAI, spoke at an Endpoints News health briefing about the company’s next steps for its AI health offering. He said the goal is to evolve ChatGPT Hea…
    Endpoints · 2h agoPositive↗ source
  • Employers and consumers poised to reshape healthcare, says Health Tech Day discussion
    Last week the organizers held their second Health Tech Day, featuring an in‑person happy hour in New York and a live virtual stream for remote attendees. The forum focused on how employers and con…
    Endpoints · 1h agoNeutral↗ source
  • Delix Therapeutics raises $100M Series C to advance non-hallucinatory psychedelic for depression
    Delix Therapeutics announced a $100 million Series C financing round, led by Johnson & Johnson’s venture arm JJDC and joined by investors such as SV Health Investors’ Dementia Discovery Fund, RA Ca…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Windward Bio targets $204M Nasdaq IPO to fund Chinese respiratory drug program
    Windward Bio, a biotech backed by Sanofi, announced plans to go public on Nasdaq with an offering of 10.3 million shares priced between $16 and $18 each. The company expects net proceeds of about $…
    Fierce Biotech · 1d agoDealNeutral↗ source
  • Argenx acquires Unnatural Products for up to $1.15 billion to boost oral peptide platform
    Argenx announced it will buy biotech Unnatural Products, paying $550 million upfront with the total deal value potentially reaching $1.15 billion through development and regulatory milestones. The…
    Fierce Biotech · 1d agoDealNeutral↗ source
  • India moves to suspend licenses of firms making substandard medicines
    The Indian government has proposed a rule that would immediately suspend the manufacturing licence of any company whose drug fails to meet quality standards. The initiative is intended to boost dr…
    raps · 1d agoRegulatoryNeutral↗ source
  • Third Rock Ventures commits up to $2.16 billion to AI-driven Chinese biotech Funnel Biosciences
    Third Rock Ventures disclosed a partnership with Chinese biotech Funnel Biosciences, committing up to $2.16 billion to support its AI-driven biologics platform. The agreement includes a research c…
    Endpoints · 22h agoDealPositive↗ source
  • Delix Therapeutics secures $100 million Series C to advance psychedelic pipeline
    Delix Therapeutics announced it has closed a $100 million Series C financing round. The capital will be used to accelerate development of its pipeline of psychedelic and neuroplastogen candidates…
    Endpoints · 1d agoDealPositive↗ source
  • Boehringer Ingelheim to seek approval for obesity injection survodutide after trial shows no added cardiovascular risk
    Boehringer Ingelheim announced it will file for regulatory approval of its investigational GLP-1 based obesity injection, survodutide, in the coming year. The move follows a phase 3 trial that dem…
    Endpoints · 1d agoApprovalNeutral↗ source
  • Merck's efinopegdutide shows strong MASH resolution in phase 2b trial
    Merck & Co. reported results from a phase 2b trial (MK-6024-013) evaluating efinopegdutide, a GLP-1 and glucagon receptor co-agonist, in patients with metabolic dysfunction-associated steatohepatit…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • Eli Lilly to pursue FDA approval for obesity drug in obstructive sleep apnea after positive Phase 3 trial
    Eli Lilly announced that it will seek regulatory approval for its obesity medication as a treatment for obstructive sleep apnea, following a successful Phase 3 study. The trial showed positive res…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • Marea Therapeutics' triglyceride drug lowers levels without raising blood sugar in high-risk patients
    Marea Therapeutics reported new data on its investigational lipid‑lowering medicine, showing it can further reduce triglyceride levels in patients with dangerously high blood concentrations. The s…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • Argenx to acquire macrocycle biotech Unnatural Products in up to $1.15 billion deal
    Argenx announced Monday it will acquire Unnatural Products, a biotech focused on macrocycle therapeutics that began as a garage startup. The transaction is structured as an up-to-$1.15 billion dea…
    Endpoints · 1d agoDealNeutral↗ source
  • Zura Bio halts hidradenitis suppurativa program after tibulizumab fails phase 2 trial
    Zura Bio announced it is ending development of tibulizumab for hidradenitis suppurativa after the drug did not meet the primary endpoint in a phase 2 study. The trial, called Tibushield, compared t…
    Fierce Biotech · 1d agoNegative readoutNegative↗ source
  • Vir Biotechnology's Phase 3 Trial Shows Primary Endpoint Success in Chronic Hepatitis Delta
    Vir Biotechnology reported that its phase 3 Eclipse 1 trial in chronic hepatitis delta met the primary endpoint. At week 48, 44% of patients who began treatment immediately showed undetectable HDV…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • Valneva's Shigella vaccine cuts infection rates in phase 2 trial
    Valneva reported that its Shigella vaccine reduced the number of intestinal infections in a phase 2 controlled human infection model study conducted in the United States. The trial enrolled 120 he…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • FDA cuts required analytical tests for emergency-use diagnostic devices in new guidance
    On 9 November 2026 the U.S. Food and Drug Administration released final guidance aimed at simplifying validation of in-vitro diagnostic devices used in public-health emergencies. The document outli…
    raps · 1d agoRegulatoryPositive↗ source