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  • Genmab reports phase 3 success for Elahere competitor and previews Merus buyout data
    Genmab disclosed at the European Society for Medical Oncology meeting that its experimental therapy, positioned as a rival to Elahere, achieved a positive outcome in a phase 3 trial. The result si…
    Fierce Biotech · 19d agoPositive readoutPositive↗ source
  • EQT to acquire Qiagen in €10.8 billion deal
    EQT, a private‑equity firm, announced it will purchase Dutch molecular diagnostics company Qiagen in a transaction valued at €10.8 billion, including €1.1 billion of net debt. The deal follows a f…
    Fierce Biotech · 20d agoDealPositive↗ source
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  • Roche warns Germany faces last chance to regain pharma investment confidence
    Roche has said that recent German healthcare reforms threaten the country's attractiveness for pharmaceutical investment. The company paused its own German investment plans after the reforms were a…
    BioSpace · 19d agoRegulatoryNegative↗ source
  • Marengo's bispecific antibody invikafusp alfa shows tumor shrinkage in 8 cancer types in Phase 2
    Marengo Therapeutics presented Phase 2 data for its bispecific antibody invikafusp alfa at the European Society for Medical Oncology meeting in Madrid. The study, part of the Start-001 first‑in‑hum…
    BioSpace · 19d agoPositive readoutPositive↗ source
  • 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 · 20d 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 · 20d agoPositive readoutPositive↗ 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 · 19d agoPositive readoutPositive↗ source
  • 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 · 19d agoNegative readoutNegative↗ 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 · 19d agoNegative readoutNegative↗ 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 · 19d agoNegative readoutNegative↗ 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 · 19d 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
  • 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 · 20d 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 · 20d agoDealPositive↗ 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 · 20d agoDealNeutral↗ 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
  • 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 · 19d 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
  • FDA approves GSK-Ionis antisense drug Hibsago, opening functional-cure market for hepatitis B
    The U.S. Food and Drug Administration has granted approval to Hibsago (bepirovirsen), a partnership product of GSK and Ionis Pharmaceuticals, marking the first antisense oligonucleotide cleared for…
    BioSpace · 21d agoApprovalPositive↗ source
  • Roivant's brepocitinib cuts steroid use in non-infectious uveitis in Phase 3 trials
    Roivant Sciences and its subsidiary Priovant reported that their TYK2/JAK inhibitor brepocitinib met all primary and secondary endpoints in two identical Phase 3 studies (Clarity‑1 and Clarity‑2) i…
    BioSpace · 21d agoPositive readoutPositive↗ 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 · 21d agoDealPositive↗ source
  • AbbVie’s HS drug lutikizumab meets Phase 3 goal but falls short of analyst expectations
    AbbVie reported that its investigational IL‑1α/β inhibitor lutikizumab achieved the primary endpoint in the Phase 3 INTREPID study for hidradenitis suppurativa, a chronic inflammatory skin disease…
    BioSpace · 20d agoNegative readoutNegative↗ 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 · 21d agoDealPositive↗ source
  • US Treasury proposes COINS Act rules that restrict biotech investment in China but leave big pharma licensing deals untouched
    The U.S. Treasury Department released draft regulations that add biotechnology to the Comprehensive Outbound Investment National Security (COINS) Act, labeling pharmaceutical compounds as prohibite…
    Fierce Biotech · 20d agoRegulatoryNeutral↗ source