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  • 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
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  • Genentech CEO Ashley Magargee reflects on biotech origins and future amid growing startup ecosystem
    Genentech’s founder story was revisited in a recent interview with CEO Ashley Magargee. She recalled how co‑founder Herbert Boyer was initially skeptical of a brief meeting with venture capitalist…
    Fierce Biotech · 22d agoPositive↗ source
  • ai3Bio raises $48 million to develop T-cell targeting therapy for autoimmune disease
    ai3Bio announced its emergence from stealth mode after securing $48 million in Series A funding. The round was led by UPMC Enterprises and Ziff Capital Partners and combines technology from Corner…
    Fierce Biotech · 22d agoDealPositive↗ 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
  • Roche halts obesity antibody emugrobart after negative phase 2 interim readout
    Roche has stopped development of its obesity antibody emugrobart after an interim analysis of a phase 2 trial indicated a low chance of meeting the study endpoints. The antibody, designed to block…
    Fierce Biotech · 22d agoNegative readoutNegative↗ source
  • Mirum's Phase 3 Trial Shows Brelovitug Achieves Primary Endpoint in Hepatitis D Study
    Mirum Pharmaceuticals reported that its phase 3 Azure-1 trial in chronic hepatitis delta met its primary efficacy goal, marking a significant step toward market entry in a field dominated by Gilead…
    Fierce Biotech · 23d agoPositive readoutPositive↗ source
  • Kodiak Sciences' eye disease drug matches Eylea in Phase 3, sending stock soaring
    Kodiak Sciences reported that two of its eye‑disease candidates performed on par with aflibercept (Eylea) in a pivotal Phase 3 trial. The data suggest comparable efficacy in treating the targeted r…
    Fierce Biotech · 23d agoPositive readoutPositive↗ source
  • Merck signs $400 million deal with China’s SciBrunch for KRAS G12D preclinical candidate
    Merck & Co. announced a new partnership with Chinese biotech SciBrunch. The agreement includes a $400 million payment for a preclinical candidate that targets the KRAS G12D mutation. The KRAS G12D…
    Fierce Biotech · 23d agoDealNeutral↗ source
  • Sofinnova Partners raises €82 million to expand medtech creation strategy in Europe and U.S.
    Sofinnova Partners announced that it has secured €82 million ($93.3 million) in an oversubscribed financing round. The capital will be used to broaden the firm’s medtech creation strategy across Eu…
    Fierce Biotech · 23d agoDealPositive↗ source
  • Merck and Daiichi withdraw lung cancer ADC filing after FDA says data insufficient
    Merck and Daiichi Sankyo have pulled their application for accelerated approval of a B7-H3-directed antibody-drug conjugate aimed at extensive-stage small cell lung cancer. The FDA indicated that…
    Fierce Biotech · 23d agoRegulatoryNegative↗ 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 · 25d 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
  • Adicet Bio's off-the-shelf CAR-T therapy shows lupus remission in early Phase 1 trial
    Adicet Bio reported that its off-the-shelf CAR-T product prula-cel induced remission in more than half of lupus patients enrolled in a small Phase 1 study. One year after a single infusion, 12 of…
    Fierce Biotech · 25d agoPositive readoutPositive↗ 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
  • Novo signs $1.3 billion deal with Nanexa to add long-acting injectables for obesity and diabetes
    Novo has entered a licensing agreement with Nanexa, valued at about 1.17 billion euros, to use Nanexa’s PharmaShell platform for its obesity and type‑2 diabetes medicines. The PharmaShell technolo…
    Fierce Biotech · 26d agoDealPositive↗ source
  • Genentech signs $1.5 billion bispecific antibody deal with Earendil Labs
    Genentech, Roche's US subsidiary, announced a licensing agreement with Earendil Labs to discover and develop multiple bispecific antibodies aimed at oncology. The agreement provides a $55 million…
    Fierce Biotech · 26d 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 · 25d 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