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  • ESMO 2026: Merck’s Kelun-partnered ADC cuts death risk by over 30% in endometrial cancer
    Sac-TMT significantly extended overall and progression-free survival for patients with advanced or recurrent endometrial cancer by 6.9 months over chemotherapy in a Phase 3 trial—becoming the first…
    BioSpace · 14d ago↗ source
  • 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 · 17d agoRegulatoryNegative↗ source
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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 · 17d 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 · 17d 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 · 17d agoNegative readoutNegative↗ source
  • Lycia Therapeutics raises $318 million in IPO to fund protein degrader programs
    Lycia Therapeutics, a biotech focused on protein-degrading medicines, priced its initial public offering at about $318 million. The proceeds will be used to advance three LYTAC drug candidates, in…
    BioPharma Dive · 18d agoDealPositive↗ 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 · 17d agoNegative readoutNegative↗ source
  • RNAi developers see surge in IPOs and funding as industry interest revives
    BioPharma Dive’s latest data‑visualization series highlights a rapid rise in interest and investment for companies developing RNA interference (RNAi) medicines. After a years‑long lull, more than…
    BioPharma Dive · 17d agoPositive↗ 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 · 17d 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 · 17d agoCRLPositive↗ 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 · 17d agoDealNeutral↗ source
  • Star raises $200 million after successful spinouts of Electra and Vega Therapeutics
    Star, a biopharma company, announced it has secured $200 million in new funding. The capital follows the recent exits of its subsidiaries Electra Therapeutics and Vega Therapeutics, which were spu…
    BioPharma Dive · 17d agoDealPositive↗ 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 · 17d 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 · 17d 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 · 17d 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 · 18d 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 · 19d agoPositive readoutPositive↗ source
  • Moderna and Merck vaccine plus Keytruda cuts melanoma relapse risk by 42% in late-stage trial
    A late-stage adjuvant study of Moderna’s experimental melanoma vaccine, intismeran autogene, combined with Merck’s Keytruda showed a 42% reduction in the risk of relapse or death compared with Keyt…
    BioPharma Dive · 18d agoPositive readoutNeutral↗ 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 · 18d agoNegative readoutNegative↗ source
  • Merck and Moderna cancer vaccine data leak shows modest benefit, shares slide
    A data leak ahead of the European Society of Medical Oncology meeting revealed early results for the personalized cancer vaccine intismeran autogene combined with Merck's Keytruda. The information…
    BioSpace · 18d agoNegative readoutNegative↗ source
  • FDA accepts new submission for Biohaven’s Vyglxia, opening path to approval
    Biohaven announced that the FDA has accepted a refreshed application for its rare disease drug Vyglxia, which targets a nerve‑damaging disorder. Vyglxia is being developed for spinocerebellar atax…
    BioPharma Dive · 18d agoRegulatoryPositive↗ source
  • Compounding pharmacy recalls copycat version of Eli Lilly’s Zepbound amid safety concerns
    Apothecary Pharma, a compounding pharmacy, has voluntarily recalled its compounded tirzepatide product that mimics Eli Lilly's obesity drug Zepbound. The company said it could not guarantee the saf…
    BioPharma Dive · 18d agoCRLNegative↗ source
  • Biohaven's ataxia drug resubmission accepted by FDA, shares surge 36%
    Biohaven’s experimental drug troriluzole, being developed for spinocerebellar ataxia, was previously rejected by the FDA because the agency questioned the design of the registrational trial. The co…
    BioSpace · 18d agoRegulatoryPositive↗ source
  • Roche reaffirms sales outlook despite weaker Xolair sales and looming generic competition
    Roche reported third-quarter group sales of 16.1 billion Swiss francs, about $19.6 billion, a 7% increase that beat analysts' consensus estimate of 15.8 billion francs. The beat was helped by a ne…
    BioPharma Dive · 18d agoEarningsNegative↗ source
  • Biotech sector logs 31 IPOs in 2026, with four more slated, still far below 2021 boom
    Biotech IPO activity has accelerated this year, with 31 companies completing public offerings so far, according to BioSpace data. This figure exceeds the totals from each of the previous four year…
    BioSpace · 18d agoDealNeutral↗ source