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  • BioNTech's HER2-directed ADC shows modest benefit and higher lung toxicity in phase 3 trial
    BioNTech reported results of its phase 3 DYNASTY-Breast02 trial evaluating trastuzumab pamirtecan (t-pam), an HER2-directed antibody-drug conjugate, in patients with HR-positive, HER2-low metastati…
    Fierce Biotech · 14d agoNegative readoutNegative↗ source
  • Australian clinical trials attract more U.S. sponsors amid regulatory uncertainty
    CROs are reporting faster startup timelines, predictable regulation, and tax incentives as reasons for increasing interest in conducting clinical trials in Australia. State-level incentives in Que…
    BioSpace · 15d agoNeutral↗ source
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  • Corxel opts for SPAC merger to take oral obesity drug public on Nasdaq
    Corxel Pharmaceuticals, an obesity-focused biotech, said it will merge with Amanat Acquisition in the first half of next year to become a publicly traded company on Nasdaq. The company’s CFO noted…
    Fierce Biotech · 14d agoDealPositive↗ source
  • Lycia Therapeutics raises $317.5 million in upsized Nasdaq IPO as Windward Bio eyes listing
    Lycia Therapeutics completed an initial public offering on Nasdaq, selling shares that generated roughly $317.5 million after the offering was upsized. The company’s debut on the exchange marks a…
    Fierce Biotech · 15d agoDealPositive↗ source
  • 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
  • Incyte reports strong early results for KRAS G12D inhibitor in pancreatic cancer, rivals RevMed
    Incyte presented phase 1 data at the European Society for Medical Oncology congress in Madrid, highlighting its KRAS G12D inhibitor INCB161734 combined with chemotherapy for pancreatic ductal adeno…
    Fierce Biotech · 15d agoPositive readoutPositive↗ source
  • J&J touts promising RIPTAC data with 59% PSA reductions in prostate cancer trial
    At the European Society for Medical Oncology (ESMO) 2026 meeting in Madrid, Johnson & Johnson presented early clinical data from its RIPTAC platform, which the company acquired through a $3 billion…
    Fierce Biotech · 15d agoPositive readoutPositive↗ source
  • ESMO: BMS’ Massacesi hails ‘very promising’ data for BioNTech-partnered PD-L1xVEGF-A drug
    Bristol Myers Squibb Chief Medical Officer Cristian Massacesi, M.D., has told Fierce that the latest data for its BioNTech-partnered PD-L1xVEGF-A drug are “very promising,” as phase 3 ambitions ram…
    Fierce Biotech · 15d agoNeutral↗ source
  • Roche reports superior survival for KRAS G12C inhibitor divarasib in phase 3 trial
    Roche presented detailed results from its phase 3 Krascendo 1 trial of the KRAS G12C inhibitor divarasib, comparing it with Amgen’s Lumakras and Bristol Myers Squibb’s Krazati. The open‑label stud…
    Fierce Biotech · 16d agoPositive readoutPositive↗ source
  • Merck and Moderna disclose phase 3 cancer vaccine data early after leak, showing improved recurrence-free survival with Keytruda
    Merck & Co. and Moderna were forced to release their phase 3 trial results for the intismeran autogene cancer vaccine two days ahead of schedule after an unexpected leak of the data ahead of the ES…
    Fierce Biotech · 17d agoPositive readoutNeutral↗ source
  • AstraZeneca says phase 3 ADC shows strong overall survival despite missing progression-free survival endpoint
    AstraZeneca executives emphasized that the detailed data from their phase 3 study of the next‑generation antibody‑drug conjugate are robust enough to be presented to regulators, even though the tri…
    Fierce Biotech · 16d agoPositive readoutNeutral↗ source
  • 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 · 17d 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 · 17d agoDealPositive↗ 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
  • 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
  • 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 · 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
  • 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
  • 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
  • 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
  • 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
  • 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