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  • Pathos AI secures $237M Series E funding at $3B valuation, partners with Bristol Myers on neuroscience
    Pathos AI, an AI-focused biotech based in New York, announced it has closed a Series E financing round raising $237 million. The round values the company at $3 billion, reflecting investor confide…
    Endpoints · 17d agoDealPositive↗ source
  • Warp Sciences raises $215 million Series A to apply AI in drug building-block design
    Former OpenAI head of science Kevin Weil announced the launch of Warp Sciences, a new startup aimed at accelerating the creation of molecular building blocks for drug discovery. The company secure…
    Endpoints · 17d agoDealPositive↗ source
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  • Gilead agrees to pay $1.28 billion upfront to China's PepStar for oral IL-23 inflammation drug candidate
    Gilead Sciences announced a deal with Chinese biotech PepStar Therapeutics to acquire an early-stage oral IL-23 inhibitor. The agreement includes an upfront payment of roughly $1.28 billion for Pe…
    Endpoints · 17d agoDealNeutral↗ source
  • Roche signs up to $813M deal with Zymeworks for preclinical trispecific T cell engager
    Roche announced a partnership with Zymeworks that includes an upfront payment of $55 million for worldwide rights to a trispecific T cell engager currently in preclinical development. The agreemen…
    Endpoints · 17d agoDealPositive↗ source
  • Bristol Myers reports patient death in autoimmune CAR-T trial and explains summer pause
    Bristol Myers Squibb disclosed that a participant in its autoimmune CAR-T cell therapy study has died. The company said the death occurred during the trial and is under investigation, with details…
    Endpoints · 17d agoNegative↗ source
  • Star Therapeutics raises $200 million to build new drug pipeline after Vega and Electra wins
    Star Therapeutics announced it has secured $200 million in financing. The capital will be used to develop its own pipeline of medicines, aiming to replicate the success of its earlier Vega and Ele…
    Endpoints · 17d agoDealPositive↗ source
  • Alnylam to launch larger study of RNA therapy for Huntington’s disease
    Alnylam Therapeutics announced it will expand its clinical program for an RNA‑based drug aimed at treating Huntington’s disease. The decision comes amid a challenging landscape for neurodegenerati…
    Endpoints · 17d agoNeutral↗ source
  • Bristol Myers Squibb identifies cause of safety signal in lupus CAR‑T trial
    Bristol Myers Squibb's cell therapy division is confronting ongoing safety challenges with its autoimmune CAR‑T program. The company says it has pinpointed the underlying cause of the safety signa…
    Endpoints · 16d agoRegulatoryNeutral↗ source
  • Biotech M&A slows sharply in Q3 as deal activity cools
    The third quarter saw a noticeable slowdown in biotech mergers and acquisitions after a busy first half of the year. Large upfront licensing agreements were fewer, and venture capital firms reduce…
    Endpoints · 17d agoDealNegative↗ source
  • Swiss biotech Windward Bio files for Nasdaq IPO to raise funds for China-derived assets and R&D
    Windward Bio, a Basel-based European biotech founded two years ago, announced it has filed its registration statements to list on Nasdaq. The company plans to use the proceeds to support two clini…
    Endpoints · 16d agoDealPositive↗ source
  • Tango combo clears Rasonque bar and Takeda's Innovent sees early returns as ESMO data leaks dampen hype
    The first day of the European Society for Medical Oncology (ESMO) congress opened in Madrid with several notable updates from the oncology field. Tango's combination therapy cleared the Rasonque r…
    Endpoints · 17d agoRegulatoryNeutral↗ source
  • Voyager Therapeutics CEO Al Sandrock to resign next year, remains on board; Insmed appoints Paul Hudson as director
    Voyager Therapeutics announced that its chief executive, Al Sandrock, will step down in the first quarter of next year. Sandrock will continue to serve on Voyager's board after his resignation, pr…
    Endpoints · 17d agoNeutral↗ source
  • Merck and Moderna’s cancer vaccine data leak precedes official Phase 3 results release
    Results from the Phase 3 trial of Moderna and Merck’s therapeutic cancer vaccine were made public on Thursday after an earlier leak of the data. The vaccine, called intismeran autogene, is being e…
    Endpoints · 17d agoNeutral↗ source
  • US Treasury drafts rules to curb American investment in Chinese biotech firms
    The Treasury Department has released draft regulations that would impose broad restrictions on U.S. companies and venture capital firms investing in or acquiring drug and biotechnology assets linke…
    Endpoints · 17d agoRegulatoryNegative↗ source
  • Pfizer and Valneva report mixed results for Lyme disease vaccine, with one analysis narrowly missing efficacy
    New data on the collaborative Lyme disease vaccine from Pfizer and Valneva were presented, showing divergent outcomes across two key analyses. One analysis met its predefined endpoints, while the o…
    Endpoints · 17d agoNegative readoutNegative↗ source
  • FDA launches Neuroscience Advancement and Innovation Nexus to boost brain disorder drug development
    The U.S. Food and Drug Administration announced a new program called the Neuroscience Advancement and Innovation Nexus (NAIN) aimed at accelerating the development of medical products for brain and…
    fda press · 17d agoRegulatoryPositive↗ source
  • Roche prepares launch of breast cancer pill giredestrant amid patient anticipation
    Roche is gearing up for the launch of its new oral breast cancer therapy, giredestrant. Teresa Graham, head of Roche's pharma unit, said patients are anxiously awaiting the drug. The announcement…
    Endpoints · 17d agoPositive↗ source
  • Regulatory update: Hepatitis B hold lifted for Arbutus drug and Ultomiris receives accelerated approval
    A regulatory update notes that the FDA has removed the clinical hold on Arbutus Biopharma's hepatitis B candidate, clearing the path for the company to resume development after a prolonged review.…
    Endpoints · 18d agoRegulatoryPositive↗ source
  • AbbVie reports Phase 3 success for lutikizumab in painful skin disease, eyes FDA filing next year
    AbbVie announced positive Phase 3 trial results for its experimental IL-1α and IL-1β inhibitor lutikizumab, which is being developed to treat a debilitating skin condition. The study reported impr…
    Endpoints · 18d agoPositive readoutPositive↗ source
  • Sanofi breaks ground on new 36,000-sq-m insulin plant in Frankfurt
    Sanofi has broken ground on a new insulin manufacturing facility at its Frankfurt site, covering roughly 36,000 square meters. The plant is part of the company’s expansion in Germany and is expect…
    Endpoints · 18d agoNeutral↗ source
  • GLP-1 drugs enter trials to test impact on alcohol and drug cravings
    GLP-1 drugs, first approved for diabetes and later for obesity, have sparked interest for broader therapeutic uses. Researchers are now launching large clinical trials to evaluate whether these ag…
    Endpoints · 18d agoNeutral↗ source
  • Georgiamune to ship preclinical solid tumor drug to Menarini in deal up to $1.1 billion
    Georgiamune, a small biotech based in Maryland, announced that it will supply its preclinical solid tumor candidate to Menarini, a family‑owned pharmaceutical company in Italy. The agreement is st…
    Endpoints · 18d agoDealNeutral↗ source
  • Roche touts strong Phase 3 track record while trimming pipeline amid peer setbacks
    Roche's chief executive Thomas Schinecker highlighted the company's high success rate in Phase 3 trials, positioning it as a competitive advantage. The comment accompanied an announcement that Roc…
    Endpoints · 18d agoPositive↗ source
  • AMA chief urges regulators to keep pace with emerging AI-driven medical care
    The American Medical Association’s chief executive highlighted the rapid progress toward autonomous, AI‑based medical treatments and warned that regulatory frameworks are lagging behind. He emphasi…
    Endpoints · 18d agoRegulatoryNeutral↗ source
  • Healthcare groups and tech firms debate FDA evidence requirements for generative AI medical devices
    Healthcare stakeholders are questioning how much clinical evidence the FDA should demand before clearing generative AI-enabled medical devices. The debate centers on balancing innovation speed with…
    Endpoints · 18d agoRegulatoryNeutral↗ source