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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 · 3d agoPositive readoutPositive↗ source
  • Immunocore reports early data showing 70% two-year survival with brenetafusp/Kimmtrak combo in uveal melanoma
    Immunocore presented early clinical data on its bispecific T-cell engager combination brenetafusp and Kimmtrak in patients with uveal melanoma. The analysis, based on a subset of patients, indicat…
    Endpoints · 3d agoPositive readoutPositive
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  • Moderna posts first profit in two years, driven by Covid-19 vaccine sales, as it refocuses on cancer vaccines
    Moderna reported a modest profit for the quarter, marking its first earnings surplus in two years. The turnaround was driven primarily by continued sales of its international Covid-19 vaccine portf…
    Endpoints · 3d agoEarningsPositive↗ source
  • 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 · 3d 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 · 3d 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 · 3d 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 · 3d agoDealNeutral↗ source
  • Sarepta halts enrollment in confirmatory Phase 3 trial of Elevidys gene therapy for Duchenne muscular dystrophy
    Sarepta Therapeutics announced it will no longer enroll additional patients in the Phase 3 confirmatory study of its gene therapy Elevidys for Duchenne muscular dystrophy. The trial was intended t…
    Endpoints · 3d agoCRLNegative↗ 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 · 3d 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 · 3d agoPositive↗ source
  • Novo and Pfizer appoint new CFOs while Alnylam sees departure of its chief commercial officer
    Novo announced the appointment of a new chief financial officer as part of its effort to improve financial leadership. The hire follows earlier reports that the company is seeking to turn a corner…
    Endpoints · 3d agoNeutral↗ 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 · 3d 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 · 3d 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 · 4d 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 · 4d 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 · 4d 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 · 4d 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 · 4d agoDealPositive↗ source
  • RevMed stock rises on early Rasonque sales as whistleblower sues Madrigal over MASH safety
    RevMed announced its first sales figures for Rasonque, a therapy targeting pancreatic cancer, and the news sent the company's shares higher. The company said the early sales data reflect market up…
    Endpoints · 4d agoNeutral↗ source
  • Caldera and Evommune secure China licensing agreements for autoimmune drug assets
    Caldera and Evommune announced they have entered licensing agreements with Chinese partners to bring their autoimmune drug programs to the Chinese market. The deals come as the biopharma sector is…
    Endpoints · 4d 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 · 4d agoNeutral↗ source
  • Merck reports positive mid-stage results for Hanmi-licensed MASH drug
    Merck announced Thursday that its dual GLP-1/glucagon agonist, which it licensed from South Korea’s Hanmi Pharmaceutical in 2020, has met its primary endpoints in a mid-stage trial for metabolic dy…
    Endpoints · 4d agoPositive readoutPositive↗ source
  • Alethio Therapeutics raises $90 million Series A to develop antibody for essential thrombocythemia
    Alethio Therapeutics, a spinout from the University of Oxford, announced a $90 million Series A financing round. The capital will fund the company’s lead program, an antibody designed to treat ess…
    Endpoints · 4d agoDealPositive↗ source
  • T-Therapeutics raises $133 million from Sanofi, J&J, Merck KGaA and Eli Lilly for TCR cancer and autoimmune programs
    T-Therapeutics, a UK biotech focused on T-cell receptor therapies for cancer and autoimmune diseases, announced it has raised $133 million in financing. The round is led by Sanofi with participati…
    Endpoints · 4d agoDealPositive↗ source
  • New treatments for preeclampsia move closer to patients
    Emily Chaddock’s experience highlights the danger of severe preeclampsia, a pregnancy complication that can threaten both mother and baby. At 27 weeks she developed the condition, leading to a rapi…
    Endpoints · 3d agoPositive↗ source