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  • Aspen Neuroscience and Bambusa Therapeutics each target $134 million IPOs
    Aspen Neuroscience, a cell‑therapy company focused on Parkinson's disease, and Bambusa Therapeutics, a bispecific biotech, have filed SEC documents outlining plans for initial public offerings. Bo…
    Fierce Biotech · 13d agoDealNeutral↗ source
  • Leak of Moderna-Merck cancer vaccine phase 3 data sparks drama at ESMO 2026 conference
    The European Society for Medical Oncology (ESMO) meeting this year was marked by an unexpected leak of phase 3 results for a cancer vaccine being developed by Moderna and Merck. The data appeared t…
    Fierce Biotech · 13d agoNeutral↗ source
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  • Gubra aims to expand beyond obesity drugs, targets first portfolio partner this year
    Copenhagen‑based biotech Gubra is currently known for its obesity drug candidates, but the company says its long‑term growth will depend on a broader pipeline beyond metabolism. The firm’s existin…
    Endpoints · 13d agoNeutral↗ source
  • FDA approves prostate cancer and Crohn’s disease therapies as judge rejects effort to block Lilly weight‑loss ads
    The U.S. Food and Drug Administration announced approvals for new treatments targeting prostate cancer and Crohn’s disease. The decisions expand therapeutic options for patients with these conditio…
    raps · 13d agoRegulatoryNeutral↗ source
  • U.S. judge rejects Novo Nordisk's bid to block Eli Lilly obesity drug ads
    A U.S. federal judge denied Novo Nordisk's request to halt television advertisements by Eli Lilly for its obesity treatments. Novo had argued the ads were misleading and sought an injunction, but…
    Endpoints · 12d agoRegulatoryNegative↗ source
  • Anthropic acquires one-person biotech Mithril Medicine to expand into life sciences
    Anthropic, known for its artificial intelligence work, announced it has purchased Mithril Medicine, a drug discovery startup run by a single individual. The deal is presented as a step in Anthropi…
    Endpoints · 12d agoDealNeutral↗ source
  • Mennonite family backs new gene-therapy startup
    A new gene‑therapy company is taking shape with financial support from members of the Amish and Mennonite communities. The story highlights the unusual partnership between a traditional religious g…
    Endpoints · 12d agoDealNeutral↗ source
  • Outpace Bio halts Phase 1 ovarian cancer CAR‑T trial
    Outpace Bio announced that it has stopped its Phase 1 trial of OPB-101, an autologous CAR‑T therapy targeting mesothelin in ovarian cancer. The company said the trial will no longer enroll patient…
    Endpoints · 13d agoNegative readoutNegative↗ source
  • FDA officials share guidance on de novo device classifications and upcoming MDUFA VI changes at MedTech Conference
    At the MedTech Conference in Boston, FDA officials and industry experts discussed de novo classification requests. They offered practical tips for companies seeking de novo designation, stressing…
    raps · 13d agoRegulatoryNeutral↗ source
  • Boehringer Ingelheim and Microsoft launch AI partnership to develop digital patient twins for clinical trials
    Boehringer Ingelheim and Microsoft announced a collaboration to investigate AI driven digital patient twins that model individual patients for clinical trial design. The work will explore disease…
    Fierce Biotech · 14d agoDealPositive↗ source
  • Anthropic IPO filing reveals plans to build a drug discovery lab and pursue AI-driven therapeutics, noting scientific and regulatory hurdles
    Anthropic, known for its Claude AI platform, disclosed in its S-1 that it intends to expand into life-science research, including establishing its own molecular biology laboratory. The company aim…
    Fierce Biotech · 14d agoNeutral↗ source
  • Tango Therapeutics reports 82% response rate for PRMT5 inhibitor combo in pancreatic cancer trial
    Tango Therapeutics announced a 14% reduction in its workforce while also presenting new data on its PRMT5 inhibitor combined with Revolution Medicines’ RAS(ON) inhibitor Rasonque at the ESMO 2026 m…
    Fierce Biotech · 14d agoPositive readoutPositive↗ source
  • Employers sue UnitedHealth, alleging overpayment of workers' medical claims
    Six major U.S. companies have filed a lawsuit against UnitedHealth Group, claiming the insurer overpaid medical claims for their employees, which they say increased their costs. The plaintiffs inc…
    Endpoints · 13d agoNegative↗ source
  • WuXi AppTec lifts 2026 revenue outlook despite US defense designation dispute
    WuXi AppTec, a leading Chinese contract research and manufacturing organization, announced it has again lifted its revenue forecast for 2026. The company said the upward revision reflects accelera…
    Endpoints · 13d agoNeutral↗ source
  • SystImmune/BMS and Hengrui showcase ADC data for EGFR-mutant lung cancer at ESMO
    At the European Society for Medical Oncology (ESMO) meeting in Madrid, Li Zhang of Sun Yat-sen University Cancer Center presented early data from the HERON‑Lung01 study, highlighting an antibody‑dr…
    Endpoints · 14d agoNeutral↗ source
  • Bristol Myers Squibb partners with Institute for Healthcare Improvement to increase cancer trial participation
    Bristol Myers Squibb has entered a three-year collaboration with the Institute for Healthcare Improvement called the Cancer Collective Action Collaborative. The program will bring together 24 team…
    Fierce Biotech · 14d agoPositive↗ source
  • 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
  • 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 · 14d 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 · 14d agoApprovalNeutral↗ source
  • Microsoft AI twice as accurate as doctors in diagnosing cases, study shows
    Microsoft announced that its artificial‑intelligence system achieved roughly double the diagnostic accuracy of physicians in a recent study. The evaluation compared the AI’s performance with that…
    Endpoints · 13d agoPositive readoutPositive↗ source
  • Roche delays European filing of breast-cancer pill giredestrant amid US pricing pressures
    Roche announced it will now seek European approval for its investigational breast cancer oral therapy giredestrant later than previously planned. The delay reflects the impact of U.S. drug pricing…
    Endpoints · 13d agoRegulatoryNeutral↗ source
  • Merck highlights oncology pipeline and cancer vaccine trial at ESMO 2026
    Merck attended the European Society for Medical Oncology (ESMO) meeting in Madrid, using the conference to present updates on its oncology portfolio. Media coverage largely centered on the company…
    Endpoints · 13d agoNeutral↗ source
  • 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 · 13d 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 · 14d agoDealPositive↗ source
  • Aspen Neuroscience and Bambusa Therapeutics each aim for $135 million IPOs
    Aspen Neuroscience announced plans to raise about $135 million through an initial public offering, proposing to sell roughly 9.38 million shares. Bambusa Therapeutics also filed for an IPO targeti…
    Endpoints · 14d agoDealNeutral↗ source