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  • Former Spark co-founder Steven Altschuler launches new immune-resetting biotech
    Steven Altschuler, who co-founded Spark Therapeutics, has announced the formation of a new biotech that aims to reset the immune system. The venture is positioned to address autoimmune diseases, a…
    Endpoints · 22d agoDealPositive↗ source
  • Novo Nordisk licenses weekly oral obesity peptide from Hengrui in up to $2.6 billion deal
    Novo Nordisk has signed a licensing agreement with China's Hengrui Pharma for a once‑weekly oral peptide, HRS‑1596, aimed at obesity and other metabolic conditions. Novo will pay $300 million upfr…
    BioSpace · 22d agoDealNeutral↗ source
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  • AI health startup Ortet launches with $500M backing from former Genentech AI team
    Ortet, a new health-technology company, announced its launch on Tuesday. The firm was founded by three former AI scientists and engineers who previously worked at Roche's Genentech division. Orte…
    Endpoints · 22d agoDealPositive↗ source
  • Novo pays $300 million upfront to license Hengrui’s weekly oral GLP-1/GIP weight-loss drug
    Novo Nordisk announced a licensing agreement with Chinese drugmaker Hengrui for a preclinical weekly oral GLP-1/GIP receptor agonist aimed at weight loss. The deal involves an upfront payment of $…
    Endpoints · 22d agoDealPositive↗ source
  • FDA approves Egetis Therapeutics' Emcitate for rare X linked disease shortening life expectancy to 35 years
    Egetis Therapeutics announced that the U.S. Food and Drug Administration has granted approval for its drug Emcitate. The therapy is intended for patients with a rare X linked genetic disorder that…
    Endpoints · 22d agoApprovalPositive↗ source
  • 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 · 22d 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 · 22d agoDealPositive↗ source
  • 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 · 22d agoDealNegative↗ source
  • SK pharmteco hosts webinar on overcoming ADC linker-payload manufacturing challenges
    SK pharmteco’s European and North American teams presented a webinar that explored the full lifecycle of antibody‑drug conjugate (ADC) linker‑payload development, from facility design to final prod…
    BioSpace · 22d agoNeutral↗ 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 · 22d agoDealNeutral↗ source
  • UniQure crashes as Huntington’s gene therapy shows less slowing of disease at 4 years
    The results are nevertheless “unprecedented,” UniQure executives said on an investor call Tuesday, emphasizing that the updated natural history database used as the control group for the Phase 1/2…
    BioSpace · 22d ago↗ 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 · 23d agoPositive readoutPositive↗ source
  • AbbVie receives FDA approval for Parkinson’s drug Juvmo, a Cerevel acquisition asset
    AbbVie has secured FDA approval for tavapadon, marketed as Juvmo, for the treatment of Parkinson’s disease in adults. The decision follows positive results from the Phase 3 TEMPO trial. In the piv…
    BioSpace · 23d agoApprovalPositive↗ source
  • Kodiak Sciences' zenkuda and tabirafusp-ted match Eylea in Phase 3, sending stock up 166%
    Kodiak Sciences announced Phase 3 results for two investigational eye‑disease drugs, zenkuda (anti‑VEGF antibody biopolymer conjugate) and tabirafusp‑ted (anti‑IL‑6/VEGF bispecific), which performe…
    BioSpace · 23d agoPositive readoutPositive↗ source
  • Mirum receives FDA approval for Atebrioz, third therapy for ultra-rare bone disease FOP
    Mirum Pharmaceuticals announced that the U.S. Food and Drug Administration approved its ALK2 inhibitor, zilurgisertib, to be marketed as Atebrioz, for the treatment of fibrodysplasia ossificans pro…
    BioSpace · 23d agoApprovalPositive↗ source
  • Merck signs up to $2.13 billion deal with SciBrunch for preclinical KRAS inhibitor SPR2015
    Merck announced it has completed a deal with Chinese biotech SciBrunch Therapeutics, paying $400 million upfront for exclusive global rights to develop, manufacture and commercialize SciBrunch’s pr…
    BioSpace · 23d agoDealPositive↗ 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 · 23d agoApprovalNeutral↗ source
  • Merck and Daiichi Sankyo pull accelerated approval request for lung cancer ADC
    Merck and Daiichi Sankyo have voluntarily withdrawn their application for accelerated approval of the antibody-drug conjugate ifinatamab deruxtecan. The FDA indicated that the data package did not…
    BioSpace · 23d agoRegulatoryNegative↗ source
  • Ultragenyx gains FDA approval for Fayuvi, a Sanfilippo syndrome A therapy, easing impact of recent Angelman setback
    Ultragenyx announced that the FDA has approved its drug Fayuvi for treating Sanfilippo syndrome type A, a rare neurodegenerative condition affecting children. The approval marks the company's first…
    BioSpace · 23d agoApprovalPositive↗ 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 · 22d 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 · 23d 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 · 23d 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 · 23d agoDealNeutral↗ source
  • Biopharma chases new immunology targets as Humira and Dupixent set high bar
    Johnson & Johnson, Pfizer, Argenx and several other companies are expanding their immunology pipelines, seeking new targets and improvements to capture part of the market driven by AbbVie’s Humira…
    BioSpace · 23d agoPositive↗ 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 · 23d agoPositive readoutNeutral↗ source