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  • Boehringer targets 2027 submission of obesity drug survodutide after positive cardiovascular trial
    Boehringer Ingelheim announced that its experimental obesity therapy survodutide is moving toward regulatory filing. The move follows the drug's successful phase 3 cardiovascular outcomes study, w…
    Fierce Biotech · 4d agoPositive readoutPositive↗ source
  • Experts warn US Treasury's biotech investment ban on China could backfire
    The U.S. Treasury released a draft policy to implement the Comprehensive Outbound Investment National Security (COINS) Act, proposing to add pharmaceutical compounds to an outbound investment black…
    Fierce Biotech · 3d agoRegulatoryNegative↗ source
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  • Moderna pauses norovirus vaccine trial after missing interim analysis
    Moderna announced it will not enroll a new cohort in the phase 3 trial of its mRNA-1403 norovirus vaccine. The decision follows a July interim analysis that showed the vaccine missed its predefine…
    Fierce Biotech · 4d agoNegative readoutNegative↗ source
  • Faeth Therapeutics reports 33% response rate in phase 2 endometrial cancer combo trial
    Faeth Therapeutics presented topline results from its phase 2 study of an oral combination targeting the PI3K/AKT/mTOR pathway in patients with advanced or recurrent endometrial cancer. The regimen…
    Fierce Biotech · 4d agoPositive readoutPositive↗ source
  • Merck ends Sutro partnership on IL-2 agonist MK-1484 amid routine pipeline prioritization
    Merck announced it is discontinuing development of MK-1484, an interleukin-2 agonist created in partnership with Sutro Biopharma. The drug entered clinical testing in 2022 as a monotherapy and in…
    Fierce Biotech · 4d agoNegative↗ source
  • Siemens Healthineers to spin off in‑vitro diagnostics unit as Olyrian Diagnostics, rebranding to Healthineers
    Siemens Healthineers announced it will separate its in‑vitro diagnostics division into a new standalone company called Olyrian Diagnostics. The carve‑out will run in parallel with a corporate name…
    Fierce Biotech · 4d agoDealNeutral↗ source
  • Onchilles reports that direct tumor injection of N17350 clears distant lesions in solid tumor models
    Onchilles, a San Diego biotech, presented data on its therapeutic elastase N17350, a vaccine‑like agent injected directly into solid tumors. In preclinical studies the intratumoral injection not o…
    Fierce Biotech · 4d agoPositive readoutPositive↗ source
  • China offers pharma firms large patient pools and early efficacy signals for global drug development
    The podcast examines how China can be woven into global clinical development strategies. It highlights that China provides access to large patient populations, early efficacy signals and a potenti…
    Fierce Biotech · 4d agoPositive↗ source
  • Axiom Biosciences pursues Hong Kong IPO and novel stem cell platform amid funding challenges
    Axiom Biosciences is charting an unconventional financing path by targeting a public listing in Hong Kong, with a long‑term goal of listing on the Nasdaq. The company is developing multiple drug d…
    Fierce Biotech · 4d agoPositive↗ source
  • FDA grants accelerated approval for Rybrevant Faspro in recurrent/metastatic head and neck cancer
    The U.S. Food and Drug Administration granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carci…
    fda press · 4d agoApprovalPositive↗ source
  • Novartis Lp(a) drug pelacarsen shows no cardiovascular benefit, raising doubts on Amgen and Lilly programs
    Novartis disclosed that its phase 3 Lp(a)Horizon trial of pelacarsen, an antisense oligonucleotide partnered with Ionis, failed to demonstrate any reduction in major cardiovascular events. The drug…
    Fierce Biotech · 5d agoNegative readoutNegative↗ source
  • Rezera targets $181 million IPO to fund phase-3 trial of NLRP3 inhibitor for peripheral artery disease
    Boston-based biotech Rezera, which rebranded from NodThera last September, said it will seek an initial public offering to raise about $181 million. The proceeds are intended to move its brain-pene…
    Fierce Biotech · 5d agoDealPositive↗ source
  • MetaVia's GLP-1/glucagon agonist cuts liver fat and weight in phase 1, eyes phase 2 in alcohol-related liver disease
    MetaVia reported that its dual GLP‑1/glucagon receptor agonist, DA‑1726, lowered liver fat and body weight in a small phase‑1 study of obese adults. After 16 weeks of once‑weekly dosing, the drug…
    Fierce Biotech · 5d agoPositive readoutPositive↗ source
  • AstraZeneca proposes $10 billion purchase of Rhythm Pharmaceuticals, sparking possible bidding war
    AstraZeneca has reportedly made an offer of about $10 billion to buy Rhythm Pharmaceuticals, a company focused on rare obesity disorders. Analysts from at least three research groups say the propo…
    Fierce Biotech · 5d agoDealNeutral↗ source
  • Evommune pays $30 million to Hinova for rights to develop oral VAV1 molecular glue degrader EVO570 outside China
    Evommune announced a licensing agreement with Chinese firm Hinova Pharmaceuticals, paying $30 million upfront for access to a preclinical molecular glue program. The agreement gives Evommune the r…
    Fierce Biotech · 5d agoDealPositive↗ source
  • Novo names former Galderma exec as new CFO as eight-year finance chief departs; Alnylam and Amgen also seek senior replacements
    Novo's chief financial officer, who has served for eight years, will step down at the end of the year. The company has selected an executive from Galderma to take over the CFO role, signaling a le…
    Fierce Biotech · 5d agoNeutral↗ source
  • Generate Biomedicines CEO touts AI-driven shrinkage of CAR-T cell engines as huge opportunity
    Generate Biomedicines' chief executive highlighted a "huge opportunity" after the company applied Anthropic's Claude AI platform to make its CAR‑T cell engines smaller. The Flagship‑founded biotec…
    Fierce Biotech · 5d agoPositive↗ source
  • Agios to cut over 202 R&D positions as it awaits FDA decision on sickle cell drug
    Agios Pharmaceuticals said it will eliminate more than 100 research and development positions by the end of 2026, cutting its R&D workforce by roughly 35% from 2025 levels. The company entered the…
    Fierce Biotech · 5d agoLayoffsNegative↗ source
  • Cloudbreak Pharma’s Phase 3 Eye Drop Shows Significant Benefit in Pterygium Trial
    Cloudbreak Pharma reported that its phase 3 trial of CBT-001, a multi‑kinase inhibitor eye drop for pterygium, met both co‑primary endpoints. The study compared two doses of CBT-001 given twice da…
    Fierce Biotech · 5d agoPositive readoutPositive↗ source
  • Vivoryon reclaims Chinese rights to kidney disease drug amid cash crunch
    Vivoryon Therapeutics, a Munich-based biotech, has taken back the rights to develop its kidney disease candidate in China after a licensing arrangement with Simcere Pharmaceuticals. The original 2…
    Fierce Biotech · 5d agoDealNeutral↗ source
  • Boehringer Ingelheim strikes $7.4 billion deal with Sino Biopharma for preclinical ADC and TCE programs
    Boehringer Ingelheim announced a major licensing agreement with China's Sino Biopharmaceutical, paying $358 million upfront for a six‑program option covering preclinical antibody‑drug conjugates an…
    Fierce Biotech · 6d agoDealPositive↗ source
  • Novo reports $2.2 bn impairment hit as pipeline setbacks spur deal hunt
    Novo's third‑quarter earnings disclosed a 15 billion Danish‑krone (about $2.2 bn) impairment charge, largely tied to recent clinical failures. The biggest components were a 4.6 bn‑krone loss from…
    Fierce Biotech · 6d agoEarningsNeutral↗ source
  • Servier’s $1.55 B Edgewise muscular dystrophy trial fails to meet primary and secondary endpoints
    Servier invested roughly $1.55 billion in Edgewise Therapeutics' muscular dystrophy program and, five months after the deal, announced that the pivotal phase 2 trial in Becker muscular dystrophy di…
    Fierce Biotech · 6d agoNegative readoutNegative↗ source
  • Madrigal ex-clinical head sues, alleging liver-injury data cover-up for Rezdiffra
    Madrigal Pharmaceuticals is being sued by its former senior vice president and head of clinical development, Michael Charlton, who claims senior leaders suppressed serious liver‑injury data for the…
    Fierce Biotech · 6d agoRegulatoryNegative↗ source
  • Minghui licenses sub-q TED drug to Japan's ASKA in up to $440 million deal
    Minghui Pharmaceutical of China has signed a licensing agreement with Japan's ASKA Pharmaceutical, granting exclusive rights to develop and sell its late‑stage thyroid eye disease (TED) candidate i…
    Fierce Biotech · 6d agoDealPositive↗ source