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  • Melanoma vaccine shows 42% risk reduction at ESMO 2026, but shares tumble on early data release
    Moderna and Merck presented Phase 3 results for their melanoma vaccine intismeran autogene at the European Society for Medical Oncology meeting. The trial reported a 42% reduction in the relative r…
    BioPharma Dive · 17d agoPositive readoutNeutral↗ source
  • Genmab’s Rina-S ADC cuts risk of progression and death in Phase 3 ovarian cancer trial
    Genmab reported results from its Phase 3 RAINFOL-02 trial of the FRα‑directed antibody‑drug conjugate Rina‑S (rinatabart sesutecan) in patients with platinum‑resistant ovarian cancer. In the inten…
    BioSpace · 17d agoPositive readoutPositive↗ source
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  • Biotech IPOs Pull in $7.5B Across 22 Deals in 2026, While Market Gains Stall in Q3
    Biopharma companies raised about $7.5 billion from 22 initial public offerings in the first three quarters of 2026, according to J.P. Morgan data. This level of financing far exceeds the eight offe…
    BioSpace · 17d agoDealNeutral↗ source
  • Merck and Moderna's mRNA melanoma vaccine shows 42% risk reduction in Phase 3 trial, easing analyst concerns
    At the European Society of Medical Oncology meeting, Merck and Moderna presented data from their Phase 3 INTerpath-001 trial of a personalized mRNA vaccine combined with Keytruda in resected melano…
    BioSpace · 17d agoPositive readoutPositive↗ source
  • Taysha and Neurogene close in on first Rett syndrome gene therapy as 2027 readouts loom
    Two companies, Taysha Gene Therapies and Neurogene, are nearing the final stage of development for gene therapies targeting Rett syndrome, a rare neurodevelopmental disorder with limited treatment…
    BioSpace · 17d agoPositive readoutPositive↗ source
  • U.S. biotechs capture 68% of global VC funding since 2025, led by Bay Area and Boston
    Since the start of 2025, U.S. biopharma firms have secured $37.2 billion in venture capital, representing about 68 % of the $54.5 billion raised worldwide. The San Francisco Bay Area and Boston do…
    BioSpace · 16d agoDealNeutral↗ source
  • Corxel to go public via $300 million SPAC merger, advancing GLP-1 pill CX11 and amylin candidate
    Corxel Pharmaceuticals announced it will become a public company by merging with the SPAC Amanat Acquisition Corp., accompanied by a $300 million private investment. The transaction will fund the…
    BioPharma Dive · 16d agoDealPositive↗ source
  • J&J's Halda-derived prostate cancer drug shows 75% response in early Phase 1 trial
    Johnson & Johnson's recent $3 billion purchase of Halda Therapeutics added an oral prostate cancer candidate, JNJ-6143, to its pipeline. The drug targets a cancer-specific protein to trigger cell d…
    BioSpace · 17d agoPositive readoutPositive↗ source
  • Patient dies after receiving Bristol Myers experimental autoimmune CAR-T therapy zola-cel
    A participant in Bristol Myers Squibb’s multiple sclerosis trial died 44 days after being infused with the experimental cell therapy known as zola-cel. The company disclosed that the patient develo…
    BioPharma Dive · 17d agoNegative readoutNegative↗ source
  • Overlooked drugs can gain value when markets evolve, says Azurity CEO
    Ron Scarboro, chief executive of Azurity Pharmaceuticals, wrote about how medicines that seemed unsuccessful can become valuable when market conditions change. He argues that the industry often co…
    BioPharma Dive · 17d agoNeutral↗ 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 · 17d agoNeutral↗ source
  • FDA Commissioner Highlights New Rare Disease Framework Emphasizing Patient Voice
    Acting US Food and Drug Administration (FDA) Commissioner Kyle Diamantas highlighted the agency's new rare disease framework during a fireside chat at the NORD Breakthrough Summit. The framework i…
    raps · 17d agoRegulatoryPositive↗ source
  • FDA clears Edwards' tricuspid valve repair device; Bayer's blood thinner asundexian approved in China
    The U.S. Food and Drug Administration has granted approval for Edwards Lifesciences' new tricuspid valve repair system, expanding treatment options for patients with tricuspid regurgitation. In Ch…
    raps · 17d agoApprovalNeutral↗ source
  • Manufacturing hurdles grow as next-gen protein therapeutics gain traction
    Cytiva's sponsored piece highlights growing interest in next-generation protein-based drugs such as antibody-drug conjugates, multispecific antibodies, fragments and synthetic peptides. These moda…
    BioPharma Dive · 17d agoNeutral↗ source
  • TGA opens consultation on temporary rise in Australian medical device annual fees
    The Therapeutic Goods Administration (TGA) in Australia announced a public consultation regarding a proposed temporary increase to the annual charges that medical device manufacturers must pay. Th…
    raps · 17d agoRegulatoryNeutral↗ source
  • BioNTech, DualityBio say ADC had ‘modest’ benefit in breast cancer study
    The companies said the findings suggest the treatment has a “limited” impact in HER2-low breast cancer, an area where AstraZeneca and Daiichi Sankyo’s Enhertu has already set a high bar.
    BioPharma Dive · 17d ago↗ 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 · 17d 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 · 20d 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 · 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 · 20d 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 · 20d 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 · 20d 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 · 20d 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 · 20d 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 · 20d agoRegulatoryNeutral↗ source