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2,174 stories matching this filter · ← front page

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  • 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
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  • 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
  • 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
  • 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 · 18d agoPositive readoutPositive↗ 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’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
  • 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 · 18d agoRegulatoryNegative↗ 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
  • 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 · 18d agoNegative readoutNegative↗ 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 · 18d agoPositive↗ 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
  • 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
  • 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
  • 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
  • Investors Re-evaluate Kidney Disease as New Cell and Gene Therapy Strategies Emerge
    In a recent episode of BioSpace's Denatured podcast, the CEOs of ProKidney and Nephrogen discussed why kidney disease has long been a difficult indication for cell and gene-based medicines. The co…
    BioSpace · 18d agoPositive↗ source