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  • Roche's Genentech reports 43% reduction in kidney damage marker in phase 3 IgA nephropathy trial
    Roche Genentech disclosed detailed results from its phase 3 IMAgINATION trial of the antisense oligonucleotide sefaxersen in patients with IgA nephropathy. The trial showed a 43.1% greater reducti…
    Fierce Biotech · 17d agoPositive readoutPositive↗ source
  • Takeda’s ADC arcotatug tavatecan shows survival benefit in phase 3 gastric cancer trial
    Takeda, together with Innovent Biologics, presented results from a late‑stage study of its next‑generation claudin‑18.2 antibody‑drug conjugate, arcotatug tavatecan (also known as IBI343 or TAK‑921…
    Fierce Biotech · 18d agoPositive readoutPositive↗ source
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  • Lycia Therapeutics raises $317.5 million in IPO as Merck halts sac-TMT trial
    Lycia Therapeutics, founded by Nobel laureate Carolyn Bertozzi, priced its initial public offering at about $317.5 million, bringing total proceeds to roughly $318 million. The offering marks the…
    Endpoints · 17d agoDealNeutral↗ source
  • 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
  • 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 · 18d 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
  • BMS reports patient death in MS CAR-T trial, cites septic pneumonia and pauses enrollment
    BMS disclosed details about a patient death that occurred in its investigational CAR-T therapy for multiple sclerosis. The autologous CD19-directed CAR-T, zolacabtagene autoleucel (zola-cel), had…
    Fierce Biotech · 17d agoNegative readoutNegative↗ 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
  • Gilead agrees to pay $1.275 billion upfront for PepStar’s oral IL‑23 inhibitor, targeting J&J’s Icotyde
    Gilead Sciences has entered into a transaction to acquire PepStar Therapeutics' oral IL‑23 receptor inhibitor program. The deal is valued at $1.275 billion in upfront cash, roughly $1.3 billion as…
    Fierce Biotech · 17d agoDealPositive↗ 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
  • Bolt Biotherapeutics to acquire Prana Therapies in reverse merger, secured $120M financing
    Bolt Biotherapeutics announced a stock‑for‑stock reverse merger with Prana Therapies. The transaction is supported by a $120 million financing package. The deal will bring Prana’s lead antibody in…
    Fierce Biotech · 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 · 18d agoNeutral↗ source
  • Roche pays $55 million upfront to Zymeworks for global rights to trispecific antibody ZW209 targeting small-cell lung cancer
    Roche has agreed to pay Zymeworks an upfront sum of $55 million for worldwide rights to ZW209, a trispecific antibody being developed for small-cell lung cancer. ZW209 is designed to bind DLL3 on…
    Fierce Biotech · 18d agoDealNeutral↗ 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 · 17d 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 · 17d 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
  • Drug safety group petitions FDA to block marketing of unapproved compounded peptides; bipartisan bill seeks clinical trial reforms
    A drug safety advocacy group has filed a citizen petition with the FDA, asking the agency to stop the marketing of compounded peptide products that lack approval. A bipartisan group of lawmakers h…
    raps · 18d agoRegulatoryNeutral↗ source
  • Experts urge cultural shift and standards to unlock real-world evidence potential in medtech
    At The MedTech Conference in Boston, experts highlighted the need for a cultural shift to build trust between regulators and medtech firms when using real-world evidence (RWE) for device marketing.…
    raps · 18d agoNeutral↗ source
  • Celltrion licenses Kaigene's preclinical antibody KG013 in deal worth up to $580.5 million
    Celltrion, a South Korean biotech, has entered into a licensing agreement with Maryland-based Kaigene for a preclinical monoclonal antibody known as KG013. KG013 is designed to block the prolifera…
    Fierce Biotech · 18d agoDealPositive↗ 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 · 18d agoNeutral↗ source
  • Menarini's Stemline signs $1.1 billion deal to license Georgiamune's preclinical cancer immunotherapy
    Georgiamune, a Maryland‑based immunology biotech, has granted Stemline Therapeutics, part of Italy's Menarini Group, exclusive worldwide rights to develop and commercialize its preclinical cancer c…
    Fierce Biotech · 19d agoDealPositive↗ source
  • FDA approves GSK hepatitis B drug; EQT to acquire Qiagen for $10.8 billion
    The U.S. Food and Drug Administration has granted approval to GlaxoSmithKline's new hepatitis B therapy, marking a regulatory milestone for the company. Private-equity firm EQT announced a definit…
    raps · 19d agoPositive↗ source