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  • Oura cancels planned IPO citing market uncertainty despite strong demand
    Oura, known for its smart ring, announced it is withdrawing its initial public offering. The company said the decision was driven by ongoing uncertainty in the IPO market, even though it continues…
    Endpoints · 1mo agoDealNeutral↗ source
  • FDA approves Emcitate for peripheral thyrotoxicosis in patients with MCT8 deficiency
    The U.S. Food and Drug Administration announced approval of Emcitate (tiratricol) tablets formulated for oral suspension to treat peripheral thyrotoxicosis in patients with MCT8 deficiency, also ca…
    fda press · 1mo agoApprovalPositive↗ source
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  • Kodiak Sciences reports Phase 3 success for Zenkuda, matching Eylea in wet AMD
    Kodiak Sciences announced that its experimental therapy Zenkuda achieved comparable efficacy to the market‑leading anti‑VEGF drug Eylea in a late‑stage trial for wet age‑related macular degeneratio…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Nonprofits launch ultra-rare immune disease gene therapy Waskyra at $3.25 million price
    Two nonprofit organizations have received FDA approval for a gene therapy that targets an ultra-rare immune disorder. The therapy, called Waskyra, is now being launched with a list price of $3.25…
    Endpoints · 1mo agoApprovalNeutral↗ source
  • AstraZeneca invests $2 billion for stake in Summit Therapeutics to back its cancer drug
    AstraZeneca announced on Monday that it will invest $2 billion to acquire a minority equity stake in Summit Therapeutics. The investment gives AstraZeneca a slice of the biotech as the companies mo…
    Endpoints · 1mo agoDealPositive↗ source
  • FDA to review and potentially overhaul PMTA rules amid lawsuit and illicit market concerns
    FDA announced it is reviewing its experience with the Premarket Tobacco Product Application (PMTA) rule and recent court actions. The agency cites the growth of an illicit market and rapid introdu…
    fda press · 1mo agoRegulatoryNeutral↗ source
  • Mirum reports Phase 3 success for its acquired hepatitis D therapy
    Mirum Pharmaceuticals announced that its recently acquired chronic hepatitis delta drug met its primary endpoint in a Phase 3 trial. The study tested a once-weekly 300 mg injection, and more than…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • White House seeks data on U.S. manufacturing of 86 essential medicines
    The White House Office of Management and Budget has launched a review of domestic production for a list of 86 medicines deemed essential. The request asks manufacturers to provide information on w…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Merck licenses KRAS G12D inhibitor from Tao Hu for $400 million upfront
    Merck has signed a licensing agreement for a KRAS G12D inhibitor, providing an upfront payment of $400 million. The deal follows a 2023 transaction in which the same entrepreneur, synthetic chemis…
    Endpoints · 1mo agoDealNeutral↗ source
  • FDA proposes new BsUFA IV commitment letter to streamline biosimilar reviews
    The U.S. Food and Drug Administration released a draft commitment letter for the Biosimilar User Fee Act (BsUFA IV) program, highlighting several departures from the existing biosimilar review fram…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA CDER chief says expanding generic GLP-1 drugs is top priority to cut American costs
    Michael Davis, director of the FDA's Center for Drug Evaluation and Research, highlighted that increasing the supply of generic GLP-1 medicines is a key focus for the agency. He noted that broader…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Adicet Bio reports early CAR-T therapy improves lupus symptoms, plans pivotal trial as shares fall
    Adicet Bio said its off-the-shelf CAR-T cell therapy showed signs of efficacy in a small early-stage trial involving patients with systemic lupus erythematosus. The study reported measurable impro…
    Endpoints · 1mo agoPositive readoutNeutral↗ source
  • Scynexis secures $200M+ BARDA contract for investigational antifungal SCY-247
    Scynexis announced a partnership with the U.S. Biomedical Advanced Research and Development Authority (BARDA) that provides more than $200 million to advance SCY-247, an experimental therapy aimed…
    Endpoints · 1mo agoDealPositive↗ source
  • Merck and Daiichi withdraw FDA accelerated approval filing for B7-H3 ADC in small cell lung cancer
    Merck and Daiichi Sankyo announced they have withdrawn their joint FDA accelerated approval filing for a B7-H3 antibody-drug conjugate intended for a subset of small cell lung cancer patients. The…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • FDA offers guidance for smoother BLA submissions and outlines biosimilar review changes
    Submitting a biologics license application requires early interaction with the FDA's Office of Therapeutic Products, careful preparation to avoid technical and administrative mistakes, and keeping…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Roche halts development of muscle-preserving obesity drug and returns program to Chugai
    Roche announced it is ending work on the experimental muscle-building compound known as GYM329, which had been tested together with a GLP-1 based anti-obesity injection. The decision stops the ong…
    Endpoints · 1mo agoNegative↗ source
  • FDA advises early engagement and error prevention for BLA submissions, says CBER expert
    A CBER specialist shared practical guidance for companies preparing biologics license applications. The expert stressed that early interaction with the FDA’s Office of Therapeutic Products can str…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Indian government approves monitoring plan for adverse events in organ and tissue transplantation products
    The Indian government has given formal approval to a new program that will track adverse events linked to medicines and biologics used in organ and tissue transplantation. The initiative is design…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA greenlights AbbVie’s next-generation Parkinson’s drug tavapadon (Juvmo) with expected lower side effects
    The U.S. Food and Drug Administration has approved AbbVie’s new therapy for Parkinson's disease, tavapadon, which will be marketed under the name Juvmo. Tavapadon is a dopamine agonist intended to…
    Endpoints · 1mo agoApprovalPositive↗ source
  • Endpoints Weekly returns with new class unveiled at Boston gala
    The newsletter marks the return of Endpoints Weekly, a regular briefing on pharmaceutical industry news. The latest edition introduced the "Endpoints 11" cohort during a gala event in Boston, and…
    Endpoints · 1mo agoNeutral↗ source
  • Merck's Welireg receives FDA nod for expanded use with Lenvima in kidney cancer
    Merck announced that its drug Welireg has received FDA approval for use together with Eisai's Lenvima in patients with advanced renal cell carcinoma. The clearance broadens the indication, allowin…
    Endpoints · 1mo agoApprovalPositive↗ source
  • Azalea Therapeutics wins Endpoints 11 award, combines gene editing with CAR-T and raises $82 million
    Azalea Therapeutics was named the winner of the Endpoints 11 2026 competition, highlighting its innovative approach in the biotech space. The company’s platform merges precise gene‑editing techniq…
    Endpoints · 1mo agoDealPositive↗ source
  • FDA approves Mirum's Atebrioz for ultra-rare disease that hardens muscle and connective tissue
    The U.S. Food and Drug Administration has granted approval for Mirum Pharmaceuticals' new therapy for an ultra-rare genetic disorder that causes muscle and connective tissue to turn into bone. The…
    Endpoints · 1mo agoApprovalPositive↗ source
  • Experts say expanding beyond rare disease markets can make ultra-rare therapies financially viable
    The piece highlights that investment in ultra‑rare disease treatments remains limited, and experts argue the answer is not to focus solely on the rare condition itself. They propose that drugmaker…
    Endpoints · 1mo agoPositive↗ source
  • NewLimit raises $682M to pursue new class of anti-aging drugs
    NewLimit, a biotech startup based in South San Francisco, announced it secured $682 million in funding. The round was led by venture firms including Kleiner Perkins, Founders Fund, Dimension Capit…
    Endpoints · 1mo agoDealPositive↗ source