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  • US Treasury proposes rule that could bar biotech investments in China
    The Treasury Department issued a proposed rule to implement the 2025 COINS Act, which governs U.S. investment in sensitive technologies in China and other countries. The proposal places a broad ra…
    Endpoints · 20d agoRegulatoryNegative↗ source
  • Alnylam to launch pivotal Huntington’s trial after early study shows strong huntingtin knockdown
    Alnylam Pharmaceuticals announced plans to move its Huntington’s disease RNAi therapy brezosiran into a pivotal, placebo‑controlled trial slated for 2027, pending regulatory alignment. The decisio…
    BioSpace · 20d agoPositive readoutPositive↗ source
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  • Tango Therapeutics reports 82% response rate for vopimetostat plus Rasonque in pancreatic cancer, down from 92% earlier
    Tango Therapeutics announced updated data from its ongoing Phase 1/2 trial combining its PRMT5 inhibitor vopimetostat with Revolution Medicines' newly approved drug Rasonque (daraxonrasib) in secon…
    BioSpace · 20d agoNegative readoutNegative↗ source
  • 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 · 20d 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 · 20d 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 · 20d 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 · 20d agoDealNeutral↗ source
  • BMS reports fatal septic pneumonia in MS patient during CAR T trial of zolacabtagene autoleucel
    BMS disclosed that a participant in its Phase 1 Breakfree-2 study of the CAR T cell therapy zolacabtagene autoleucel died from septic pneumonia. The patient, who had highly active relapsing multip…
    BioSpace · 20d agoNegative readoutNegative↗ 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 · 20d 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 · 20d agoNegative↗ source
  • US proposes new biotech investment limits on China, but licensing deals remain allowed
    The U.S. Treasury announced a proposal to curb outbound investments in Chinese biotechnology, citing national‑security concerns. The plan would limit U.S. persons from funding certain bio‑derived c…
    BioSpace · 20d agoRegulatoryNeutral↗ source
  • FDA lifts hold on Aardvark Therapeutics' ARD-101 after safety study shows no cardiac events
    FDA has lifted the clinical hold on Aardvark Therapeutics' ARD-101 after the company completed an additional safety study. The new data showed no cardiac events, addressing the concerns that prompt…
    BioSpace · 20d agoCRLPositive↗ 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 · 20d 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 · 20d 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 · 19d 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 · 20d agoDealNegative↗ source
  • Roche bets up to $813M on Zymeworks’ lung cancer trispecific T cell engager
    Roche will pay Zymeworks $55 million upfront plus another $40 million once the partnership asset enters Phase 1b development and up to $718 million in additional milestones.
    BioSpace · 20d agoDealNeutral↗ 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 · 19d 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 · 20d 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 · 20d 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 · 20d 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 · 20d agoNeutral↗ source
  • Gilead shops in IL-23, inking $1.3B upfront I&I deal with China’s PepStar
    Gilead Sciences has picked up a new inflammatory disease program from China’s PepStar Therapeutics to pair with the Phase 2 inflammatory bowel disease asset emvistegrast.
    BioSpace · 20d ago↗ source
  • FDA uncages Aardvark’s Prader-Willi study after new data cleared safety concerns
    After cardiac safety signals led to a full clinical hold on Aardvark Therapeutics’ studies of ARD-101, the biotech conducted an additional safety study, in which no cardiac events were detected. Aa…
    BioSpace · 20d ago↗ source
  • FDA uncages Aardvark’s Prader-Willi study after new data cleared safety concerns
    After cardiac safety signals led to a full clinical hold on Aardvark Therapeutics’ studies of ARD-101, the biotech conducted an additional safety study, in which no cardiac events were detected. Aa…
    BioSpace · 20d ago↗ source