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  • Trade group warns stalled biosimilar development could forfeit billions in savings
    A trade association that represents generic drug makers and biosimilar developers released a new report warning that progress on biosimilar products has slowed. The group says the slowdown threaten…
    Endpoints · 1mo agoNegative↗ source
  • Takeda R&D chief Andy Plump to retire in 2027 as Novo Nordisk names Alex Hoffman global research head
    Takeda announced that its head of research and development, Andy Plump, will step down in June 2027. Plump, who joined Takeda from Sanofi in 2015 and has led R&D since December 2018, will retire af…
    Endpoints · 1mo agoNeutral↗ source
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Alzheon seeks up to $500M in new financing after Phase 3 setback for Alzheimer’s drug
Alzheon, a biotech based in Framingham, Massachusetts, has been pursuing an Alzheimer’s therapy for more than a decade. Its lead candidate recently failed to achieve the primary goals in a Phase 3…
Endpoints · 1mo agoDealNeutral↗ source
  • FDA grants three-month review extension for Exelixis' metastatic colorectal cancer candidate
    Exelixis, a California drug developer, has provided the FDA with additional safety and efficacy data for its experimental therapy aimed at treating metastatic colorectal cancer. The agency respond…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • FDA signals openness to innovative trial designs for psychedelic therapies
    FDA regulators said they are willing to consider more flexible approaches for evaluating psychedelic medicines. The agency noted that studies could use active comparators instead of placebo, which…
    Endpoints · 1mo agoRegulatoryPositive↗ source
  • Shionogi's mid-stage stroke drug redasemtide fails, while Bayer's Hyrnuo receives expanded NSCLC label
    Shionogi reported that its experimental stroke therapy redasemtide did not achieve the primary endpoint in a mid-stage clinical trial, marking a setback for the company’s neurology pipeline. The f…
    Endpoints · 1mo agoNegative readoutNeutral↗ source
  • ARPA-H launches ADVOCATE program to fund AI agents for health tech companies
    ARPA-H, the federal agency that funds breakthrough health technologies, announced the start of a new initiative called ADVOCATE. The program will award millions of dollars in grants to health-tech…
    Endpoints · 1mo agoPositive↗ source
  • FDA imposes partial clinical hold on Biohaven's experimental epilepsy drug BHV-7000
    FDA announced a partial clinical hold on Biohaven's ion channel program, affecting the epilepsy trial of the experimental drug BHV-7000. The hold was issued after the agency requested additional p…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • BridgeBio Oncology shares tumble 24% as it narrows KRAS program focus
    BridgeBio Oncology Therapeutics saw its stock drop sharply after announcing a strategic shift. The company said it will scale back its broader pipeline to concentrate resources on its lead KRAS in…
    Endpoints · 1mo agoNegative↗ source
  • Pharma investment in UK rises as government increases drug pricing and engagement
    The UK trade group says pharmaceutical investment is picking up after a lull last year. The uptick follows recent government steps to raise reimbursement rates for medicines and to foster closer c…
    Endpoints · 1mo agoRegulatoryPositive↗ source
  • Lonza announces new spray-drying plant in Bend, Oregon as Samsung Bio secures $262 million contract
    Lonza announced plans to construct a new commercial spray-drying facility in Bend, Oregon, expanding its manufacturing footprint in the United States. The plant will increase Lonza’s capacity to p…
    Endpoints · 1mo agoPositive↗ source
  • Biotech industry rebounds as Endpoints 11 awards return in Boston
    The article notes that the Endpoints 11 awards will be unveiled in Boston on the night of September 24, marking the event’s return after a period of industry slowdown. It reflects on how the biote…
    Endpoints · 1mo agoNeutral↗ source
  • Oura files S-1, outlining its plans to expand into healthcare as it prepares for IPO
    Oura, known for its sleep-tracking ring, has submitted a registration statement on Form S-1 as it moves toward an initial public offering. In the filing, the company describes a broader healthcare…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Encoded Therapeutics raises $275 million in Series F round for Dravet syndrome program
    Encoded Therapeutics announced closing a Series F financing round that brought in $275 million. The round was led by GV with participation from an undisclosed healthcare investor. The new capital…
    Endpoints · 1mo agoDealPositive↗ source
  • Research on orexin and narcolepsy earns Lasker Award for Yanagisawa and Mignot
    Masashi Yanagisawa and Emmanuel Mignot were honored with the Lasker Award for their work uncovering the role of orexin in narcolepsy. The award was announced on September 9, 2026. Their research b…
    Endpoints · 1mo agoPositive↗ source
  • Compass Pathways reports positive one-year data for its psilocybin therapy COMP360
    Compass Pathways released results from a one-year study of its psilocybin‑based therapy COMP360. The company described the data as positive, indicating continued promise for the investigational tre…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • TwoStep Therapeutics raises $62.5 million Series A backed by Pfizer and Merck KGaA venture groups
    TwoStep Therapeutics, a cancer biotech, announced a $62.5 million Series A financing to advance its novel approach to antibody-drug conjugates and radioligand therapies. The round was supported by…
    Endpoints · 1mo agoDealPositive↗ source
  • Kura Oncology spins out diabetes program into new company with $50M funding and Lilly support
    Kura Oncology, known for its leukemia menin inhibitor Komzifti, announced it is separating its diabetes research into a newly formed company. The new entity will receive $50 million in financing,…
    Endpoints · 1mo agoDealPositive↗ source
  • Tyra Biosciences reports Phase 2 success in low-risk bladder cancer, plans pivotal trial
    Tyra Biosciences announced that its experimental therapy for low‑risk bladder cancer has produced encouraging results in a Phase 2 study. The company said the data, released on Wednesday, represen…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • ARPA-H selects UpDoc, Tempus AI and Atman Health for new AI heart-disease program
    ARPA-H announced a new initiative called ADVOCATE that will bring together three companies to develop AI-driven tools for managing heart disease. The selected firms - UpDoc, Tempus AI, and Atman H…
    Endpoints · 1mo agoPositive↗ source
  • Beeline Medicines reports promising Phase 2 lupus data
    Beeline Medicines, a Bain‑backed startup, announced encouraging mid‑stage results for its lupus candidate afimetoran, a drug originally sourced from Bristol Myers Squibb. The Phase 2 trial data we…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Researchers urge FDA to adopt EMA-style drug rejection letter disclosures
    The FDA began publishing letters that explain why a drug application was denied in September 2025, marking a significant transparency shift. Researchers argue that the agency’s current disclosures…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • NodThera rebrands as Rezera and targets Phase 3 trial in 2027
    NodThera, a biotech focused on the NLRP3 inflammatory pathway for about ten years, announced a strategic shift. The company said it will rebrand itself as Rezera and is preparing to launch a pivot…
    Endpoints · 1mo agoNeutral↗ source
  • Evommune's MRGPRX2 antagonist fails second Phase 2b trial in atopic dermatitis
    Evommune reported that its experimental small-molecule antagonist of the MRGPRX2 receptor did not meet its primary endpoints in a Phase 2b study in patients with atopic dermatitis. The study, cond…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • Amgen reports positive lung cancer trial results for Imdelltra combined with checkpoint inhibitor
    Amgen announced that its T-cell engager candidate Imdelltra, when used together with a checkpoint inhibitor, showed a clinical benefit in patients with advanced lung cancer. The trial data indicat…
    Endpoints · 1mo agoPositive readoutPositive↗ source