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  • BioNTech, DualityBio weigh future of HER2 ADC after modest Phase 3 breast cancer results
    BioNTech and DualityBio are assessing next steps for their HER2-targeted antibody-drug conjugate trastuzumab pamirtecan after a Phase 3 trial in breast cancer. The trial met its primary endpoint,…
    Endpoints · 15d agoPositive readoutNeutral↗ 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 · 15d agoRegulatoryNeutral↗ source
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  • 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 · 14d ago↗ source
  • Roche's KRAS G12C inhibitor cuts death risk by 44% versus Amgen and BMS in lung cancer trial
    At the European Society for Medical Oncology meeting in Madrid, Roche presented data on its next‑generation KRAS G12C inhibitor in non‑small cell lung cancer. In a head‑to‑head study against compa…
    Endpoints · 15d agoPositive readoutPositive↗ source
  • Akeso reports survival benefit for ivonescimab in China-only biliary tract cancer trial, likening results to Keytruda
    Akeso announced new data from a late‑stage study of its PD‑1×VEGF bispecific antibody ivonescimab in patients with biliary tract cancer enrolled only in China. The trial showed an improvement in o…
    Endpoints · 15d agoPositive readoutPositive↗ source
  • Pfizer shifts focus after lung cancer trial setback, cites early signals in earlier-line patients; BioNTech and BMS report initial activity
    Pfizer’s late‑stage trial in non‑small cell lung cancer did not meet its primary endpoint, prompting the company to highlight a post‑hoc analysis that suggests benefit for patients treated earlier…
    Endpoints · 16d agoNeutral↗ source
  • AstraZeneca reports Tagrisso-Orpathys combo could prolong treatment for EGFR-mutant lung cancer
    At the European Society for Medical Oncology meeting, AstraZeneca said early data suggest that adding Orpathys to Tagrisso may let patients with mutant non‑small cell lung cancer continue therapy a…
    Endpoints · 15d agoPositive readoutPositive↗ source
  • #ESMO26: Merck and Moderna's cancer vaccine data were 'a triumph of science.' And now, the work begins
    MADRID — In a testament to clinicians’ interest in Merck and Moderna’s personalized cancer vaccine data at this year’s European Society for Medical Oncology conference, the presidential symposium,…
    Endpoints · 15d ago↗ source
  • Amgen's Imdelltra plus AstraZeneca's Imfinzi cuts death risk by 58% in small cell lung cancer Phase 3 trial
    Amgen reported results from a Phase 3 trial evaluating its investigational therapy Imdelltra in combination with AstraZeneca’s immunotherapy Imfinzi in patients with small cell lung cancer. The st…
    Endpoints · 16d agoPositive readoutPositive↗ source
  • Merck and Moderna present Phase 3 cancer vaccine data at ESMO26 amid Treasury proposal on China investment
    Endpoints Weekly reporter Nicole DeFeudis writes from Madrid during the ESMO26 meeting. The most anticipated presentation was a Phase 3 study of a cancer vaccine jointly developed by Merck and Mod…
    Endpoints · 17d agoNeutral↗ source
  • Tonight We Ride recalls Ultimate Forza male supplement after finding undeclared sildenafil, tadalafil and dapoxetine
    Tonight We Ride, LLC of Lakeville, Minnesota announced a voluntary recall of its Ultimate Forza male supplement capsules. The recall was triggered after testing revealed the product contains undec…
    fda recalls · 16d agoCRLNegative↗ source
  • AstraZeneca, Lilly and Bayer unveil new strategies at ESMO 2026 in Madrid
    At the European Society for Medical Oncology (ESMO) congress in Madrid, nearly 40,000 delegates gathered for the five-day meeting. AstraZeneca said it is evaluating the use of its immunotherapy Ke…
    Endpoints · 16d agoNeutral↗ source
  • US Treasury proposes rule that could bar biotech investments in China
    The Treasury Department issued a proposed rule to implement the 2025 COINS Act, which governs U.S. investment in sensitive technologies in China and other countries. The proposal places a broad ra…
    Endpoints · 17d agoRegulatoryNegative↗ source
  • Lycia Therapeutics raises $317.5 million in IPO as Merck halts sac-TMT trial
    Lycia Therapeutics, founded by Nobel laureate Carolyn Bertozzi, priced its initial public offering at about $317.5 million, bringing total proceeds to roughly $318 million. The offering marks the…
    Endpoints · 17d agoDealNeutral↗ source
  • Pathos AI secures $237M Series E funding at $3B valuation, partners with Bristol Myers on neuroscience
    Pathos AI, an AI-focused biotech based in New York, announced it has closed a Series E financing round raising $237 million. The round values the company at $3 billion, reflecting investor confide…
    Endpoints · 17d agoDealPositive↗ source
  • Warp Sciences raises $215 million Series A to apply AI in drug building-block design
    Former OpenAI head of science Kevin Weil announced the launch of Warp Sciences, a new startup aimed at accelerating the creation of molecular building blocks for drug discovery. The company secure…
    Endpoints · 18d agoDealPositive↗ source
  • Gilead agrees to pay $1.28 billion upfront to China's PepStar for oral IL-23 inflammation drug candidate
    Gilead Sciences announced a deal with Chinese biotech PepStar Therapeutics to acquire an early-stage oral IL-23 inhibitor. The agreement includes an upfront payment of roughly $1.28 billion for Pe…
    Endpoints · 18d agoDealNeutral↗ 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
  • 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
  • Roche signs up to $813M deal with Zymeworks for preclinical trispecific T cell engager
    Roche announced a partnership with Zymeworks that includes an upfront payment of $55 million for worldwide rights to a trispecific T cell engager currently in preclinical development. The agreemen…
    Endpoints · 17d agoDealPositive↗ source
  • Bristol Myers reports patient death in autoimmune CAR-T trial and explains summer pause
    Bristol Myers Squibb disclosed that a participant in its autoimmune CAR-T cell therapy study has died. The company said the death occurred during the trial and is under investigation, with details…
    Endpoints · 17d agoNegative↗ source
  • Star Therapeutics raises $200 million to build new drug pipeline after Vega and Electra wins
    Star Therapeutics announced it has secured $200 million in financing. The capital will be used to develop its own pipeline of medicines, aiming to replicate the success of its earlier Vega and Ele…
    Endpoints · 18d agoDealPositive↗ source
  • Alnylam to launch larger study of RNA therapy for Huntington’s disease
    Alnylam Therapeutics announced it will expand its clinical program for an RNA‑based drug aimed at treating Huntington’s disease. The decision comes amid a challenging landscape for neurodegenerati…
    Endpoints · 18d agoNeutral↗ source
  • 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