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  • BioNTech's CTLA-4 antibody gotistobart shows 8.5-month survival boost in previously treated lung cancer patients
    BioNTech reported new data on its CTLA-4 targeting antibody gotistobart in lung cancer. The study focused on patients whose disease had progressed after prior therapy. Those receiving gotistobart…
    Endpoints · 1h agoPositive readoutPositive↗ source
  • Scholar Rock receives FDA approval for apitegromab (Isembyld) to treat spinal muscular atrophy
    Scholar Rock announced FDA approval for its injectable drug apitegromab, marketed as Isembyld, for treating spinal muscular atrophy, a rare muscle-wasting condition. The approval follows earlier s…
    Endpoints · 8h agoApprovalPositive↗ source
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  • Corbus reports phase 1b obesity data showing lower neuropsychiatric side effects for CB1 antagonist
    Corbus Pharmaceuticals released results from a phase 1b trial of its CB1 inverse agonist aimed at treating obesity. The study indicated the drug lowered rates of depression, anxiety, irritability a…
    Fierce Biotech · 9h agoPositive readoutPositive↗ source
  • Cellectis drops its allogeneic CAR-T candidates lasme-cel and eti-cel amid rising competition from in-vivo therapies
    Cellectis announced it is terminating development of its two allogeneic CAR-T programs, lasme-cel for B-cell acute lymphoblastic leukemia and eti-cel for non-Hodgkin lymphoma. The move reflects a…
    Fierce Biotech · 14h agoNegative↗ source
  • FDA seeks external input on rare disease trial criteria and endpoint selection
    The FDA announced it will seek additional external feedback as it reviews how to evaluate efficacy and safety data for rare disease therapies. The agency noted the difficulty of setting appropriat…
    Endpoints · 1h agoRegulatoryNeutral↗ source
  • GSK reports 94% response rate for Jideytro in ROS1-positive lung cancer at World Conference
    GSK is moving a newly acquired lung-cancer drug, Jideytro, toward FDA review after presenting data at the World Conference on Lung Cancer. The conference data showed a 94% response rate when Jidey…
    Endpoints · 4h agoPositive readoutPositive↗ source
  • Sanofi-backed Electra Therapeutics targets $297 million IPO as Enhertu shows Phase 3 lung cancer success
    Electra Therapeutics, a biotech company supported by Sanofi, announced plans to raise roughly $297 million through an initial public offering. The firm hopes to launch the offering shortly after La…
    Endpoints · 5h agoDealPositive↗ source
  • Eli Lilly halts early-stage obesity drug LY4064912 after failing to meet development criteria
    Eli Lilly announced it is ending development of its early-stage obesity candidate, LY4064912, after the phase 1 study did not achieve the company’s expectations. The first‑in‑human trial enrolled…
    Fierce Biotech · 7h agoNegative↗ source
  • AstraZeneca's Etcamah fails late-stage trial for early-stage breast cancer use
    AstraZeneca announced that its newly approved breast cancer therapy, Etcamah, did not meet its primary goals in a pivotal study aimed at expanding the drug's label. The trial evaluated Etcamah in…
    Endpoints · 8h agoNegative readoutNegative↗ source
  • Definium Therapeutics reports positive Phase 3 results for oral LSD anxiety drug DT120
    Definium Therapeutics announced Monday that its experimental oral LSD formulation, DT120, achieved positive outcomes in a Phase 3 trial targeting an anxiety disorder. The trial, the company's thir…
    Endpoints · 8h agoPositive readoutPositive↗ source
  • Electra Therapeutics targets up to $342M IPO to fund phase 2/3 study of ipsoprubart for rare inflammatory syndrome
    Electra Therapeutics, based in South San Francisco, filed with the SEC indicating plans to sell 21.7 million shares at $14‑$16 each. The company expects net proceeds of about $296.6 million, poten…
    Fierce Biotech · 11h agoDealNeutral↗ source
  • Roche-MediLink’s B7-H3 ADC meets primary endpoint in phase 3 SCLC trial, median survival 13.3 months
    Roche and its partner MediLink reported phase 3 results for the B7-H3-directed antibody-drug conjugate (ADC) in small-cell lung cancer. The trial met its primary endpoint, with a median overall sur…
    Fierce Biotech · 14h agoPositive readoutNeutral↗ source
  • GSK to close German vaccine plant and cut 650 jobs as flu vaccine demand falls
    GSK announced it will wind down its vaccine manufacturing site in Germany, ending operations at the facility. The decision follows a rigorous review and reflects a decline in demand for egg‑based…
    Endpoints · 3h agoLayoffsNegative↗ source
  • Novo Nordisk rebrands as 'Novo' and launches new culture strategy after recent setbacks
    Novo Nordisk announced it will drop "Nordisk" from its public brand, opting to be known simply as "Novo" starting Monday. The name change is part of a broader cultural overhaul aimed at revitalizi…
    Endpoints · 8h agoNeutral↗ source
  • Novo rebrands, drops 'Nordisk' to become simply 'Novo' in market push
    Novo Nordisk announced a major rebranding that will see the company drop the "Nordisk" part of its everyday brand. The legal name Novo Nordisk A/S remains unchanged, but the company will be known s…
    Fierce Biotech · 13h agoPositive↗ source
  • J&J nears $20 billion sale of DePuy Synthes orthopedics unit to Apollo
    Johnson & Johnson is in advanced talks to sell its DePuy Synthes orthopedics business to private-equity firm Apollo Global Management for roughly $20 billion, according to Bloomberg. The deal woul…
    Fierce Biotech · 1d agoDealNeutral↗ source
  • Akeso and Summit report survival advantage for PD-1xVEGF combo over Keytruda
    At the American Society of Clinical Oncology (ASCO) 2026 meeting, Akeso Biopharma and its partner Summit Therapeutics announced new survival results for their experimental PD‑1×VEGF bispecific anti…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • GE HealthCare eyes $1 billion purchase of radiopharmaceutical developer Sofie Biosciences
    GE HealthCare is reported to be weighing a purchase of Sofie Biosciences, a radiopharmaceutical developer, for as much as $1 billion, according to the Financial Times. Sofie Biosciences, based in…
    Fierce Biotech · 1d agoDealNeutral↗ source
  • Novartis encounters setbacks while AI firm Anthropic searches for a dealmaker
    The latest Endpoints Weekly edition highlights a difficult period for Novartis, noting that the company is facing a series of setbacks. Details of the challenges are not provided, but the report s…
    Endpoints · 2d agoNeutral↗ source
  • Cullinan and Taiho report six-month survival gain for EGFR exon 20 NSCLC in phase 3 trial
    Cullinan Therapeutics and Taiho Oncology presented interim data from their phase 3 Rezilient3 study, which evaluated the tyrosine kinase inhibitor zipalertinib combined with platinum‑based chemothe…
    Fierce Biotech · 3d agoPositive readoutPositive↗ source
  • BioNTech's gotistobart shows 18.5-month median survival in relapsed squamous lung cancer, beating docetaxel
    BioNTech presented updated data from its phase 3 Preserve-003 trial at the World Conference on Lung Cancer in Seoul. The trial compares its anti-CTLA-4 antibody gotistobart with standard chemothera…
    Fierce Biotech · 3d agoPositive readoutPositive↗ source
  • GSK’s risvutatug rezetecan shows 18.5-month median overall survival in phase 3 SCLC trial
    GSK, together with Chinese partner Hansoh Pharma, reported results of its antibody‑drug conjugate risvutatug rezetecan (ris‑rez) in a phase 3 trial for relapsed small‑cell lung cancer. The study e…
    Fierce Biotech · 3d agoPositive readoutPositive↗ source
  • Definium Therapeutics clinches third phase-3 win for LSD anxiety drug, eyes FDA filing
    Definium Therapeutics reported another successful phase 3 trial of its LSD‑based anxiety treatment, DT120 ODT. The Panorama study enrolled 245 patients and compared a 100 µg dose of DT120 with pla…
    Fierce Biotech · 3d agoPositive readoutPositive↗ source
  • Revolution Medicines secures FDA approval for Rasonque, a RAS inhibitor targeting advanced pancreatic cancer
    Revolution Medicines announced FDA approval of its RAS inhibitor Rasonque for patients with advanced pancreatic cancer, marking a milestone for the company. The approval is seen as a breakthrough…
    Fierce Biotech · 3d agoApprovalPositive↗ source
  • Yarrow Bioscience raises $150M as AbbVie reports positive menstrual migraine trial results
    Yarrow Bioscience, based in New Haven, announced pricing of a $150 million equity offering at $26 per share, roughly $2.50 below the previous closing price. The capital raise will provide addition…
    Endpoints · 3d agoPositive readoutPositive↗ source