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1,547 stories matching this filter · ← front page

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  • SK pharmteco commits over $200 million to expand CDMO infrastructure, adding 100 jobs over five years
    SK pharmteco announced a plan to invest at least $200 million in building out its development and manufacturing infrastructure over the next five years. The funding is aimed at expanding the compa…
    Endpoints · 21d agoPositive↗ source
  • Swedish biotech AnaCardio secures $70.9M Series B to advance heart failure drug
    Swedish biotech AnaCardio announced a Series B financing round that raised €62.5 million ($70.9 million). The capital will be used to move its chronic advanced heart failure drug toward registrati…
    Endpoints · 21d agoDealPositive↗ source
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  • BioNTech to shut three German manufacturing sites after sale talks fall through
    BioNTech announced it will close three of its manufacturing facilities in Germany. The decision follows months of searching for buyers for the sites. The company said it was unable to secure a dea…
    Endpoints · 21d agoDealNegative↗ source
  • 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 · 21d agoDealNeutral↗ source
  • 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 · 22d 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 · 22d 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 · 21d agoDealPositive↗ 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 · 22d 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 · 22d 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 · 22d agoDealNeutral↗ 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 · 22d 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 · 22d 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 · 22d agoRegulatoryNegative↗ 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 · 22d agoNegative↗ 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 · 24d 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 · 24d 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 · 25d 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 · 25d 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 · 24d 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 · 25d 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 · 25d agoDealPositive↗ source
  • SonoThera secures $186 million to advance non-viral gene-therapy platform
    SonoThera, the winner of the Endpoints 11 2026 competition, announced a fresh financing round to push its non-viral gene-therapy technology forward. The company raised a total of $186 million, wit…
    Endpoints · 25d agoDealPositive↗ source
  • ADARx prices $446.3 million Nasdaq debut, boosting biotech IPO wave
    ADARx Pharmaceuticals, a RNA interference focused biotech, announced pricing of its initial public offering at $446.3 million on Nasdaq. The offering was upsized, reflecting strong investor demand…
    Endpoints · 25d agoDealNeutral↗ source
  • Pharma groups urge FDA to clarify criteria for approving drugs based on a single pivotal trial
    Pharmaceutical companies and industry associations are asking the U.S. Food and Drug Administration for more detailed guidance on when a single pivotal clinical trial, supported by additional confi…
    Endpoints · 25d agoRegulatoryNeutral↗ source
  • Anew Labs, ByteDance’s biotech spinout, raises $290M to build a China AI bio rival
    Anew Labs, a biotech spinout from ByteDance, announced it has secured $290 million in funding. The capital came from a mix of Chinese investors such as HSG, IDG Capital and Hillhouse Investment, a…
    Endpoints · 25d agoDealPositive↗ source