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  • AstraZeneca reports Phase 3 trial shows Imfinzi-Padcev combo improves survival in bladder cancer
    AstraZeneca announced that its Phase 3 study of the immunotherapy Imfinzi combined with the antibody‑drug conjugate Padcev, developed with Pfizer and Astellas, extended overall survival for patient…
    Endpoints · 6mo agoPositive readoutPositive↗ source
  • Regenxbio reports key gene therapy results, moves toward FDA accelerated clearance for Duchenne
    Regenxbio said its experimental gene therapy RGX-202 met the primary endpoint in a pivotal Duchenne muscular dystrophy trial, positioning the company to file for accelerated FDA clearance. In the…
    BioPharma Dive · 6mo agoRegulatoryPositive↗ source
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  • Create Medicines secures $122M Series B to advance in vivo CAR-T therapies
    Create Medicines, a Cambridge biotech, announced a $122 million Series B financing to expand its in vivo CAR-T cell therapy platform targeting cancer and autoimmune diseases. The round was co-led…
    BioPharma Dive · 6mo agoDealPositive↗ source
  • BeOne Medicines receives accelerated FDA approval for sonrotoclax in mantle cell lymphoma
    BeOne Medicines announced that the U.S. Food and Drug Administration granted accelerated approval to its BCL2 inhibitor sonrotoclax for treatment of mantle cell lymphoma. The approval is based on…
    Endpoints · 6mo agoApprovalPositive↗ source
  • Encoded Therapeutics gene therapy cuts seizures 76% in Dravet syndrome children
    Encoded Therapeutics presented data at the ASGCT26 meeting showing its gene therapy achieved a 76% reduction in seizures among children with Dravet syndrome. The result was observed in three patie…
    Endpoints · 6mo agoPositive readoutPositive↗ source
  • Degron Therapeutics raises $40M in Series A extension, total $95M, as Cabaletta releases early CAR‑T data
    Degron Therapeutics, a US‑China biotech focused on molecular‑glue degrader technology, announced an additional $40 million in Series A extension funding, bringing its total capital raised to $95 mi…
    Endpoints · 6mo agoDealNeutral↗ source
  • Biogen's anti-tau Alzheimer drug BIIB080 fails primary endpoint in Phase 2, but shows slower decline
    Biogen reported results of its Phase 2 trial of BIIB080, a tau-targeting therapy for Alzheimer’s disease. The study’s primary endpoint was not met, meaning the drug did not achieve the pre-specifi…
    Endpoints · 6mo agoNegative readoutNeutral↗ source
  • Regenxbio reports positive Duchenne gene therapy trial results, targets FDA approval by 2027
    Regenxbio announced that its gene therapy for Duchenne muscular dystrophy achieved the required endpoints in a pivotal clinical trial. The data met the study's predefined criteria, which the compa…
    Endpoints · 6mo agoPositive readoutPositive↗ source
  • MacroGenics sells manufacturing operations to Bora for $122.5M; West Pharma reports cybersecurity breach
    MacroGenics announced it is selling its clinical and commercial drug substance manufacturing portfolio to CDMO Bora. The deal includes an upfront payment of $122.5 million. The transaction transfe…
    Endpoints · 6mo agoDealNeutral↗ source
  • Biogen pushing tau drug forward despite Alzheimer’s study failure
    One of the company’s more closely watched research assets, BIIB080 is now heading to late-stage testing based on “the strength of the biomarker and efficacy data” seen in a Phase 2 trial.
    BioPharma Dive · 6mo agoRegulatoryNeutral↗ source
  • In vivo CAR-T therapies dominate talks at ASGCT 2026 conference
    The reporter is on the ground in Boston covering the American Society of Gene & Cell Therapy's annual meeting. Sessions across the conference are highlighting in vivo CAR-T approaches, showing tha…
    Endpoints · 6mo agoNeutral↗ source
  • Pharma firms must complete extensive paperwork and undergo monitoring to qualify for a 20% tariff reduction
    The Department of Commerce announced that pharmaceutical manufacturers must complete a detailed application to qualify for a reduced 20% tariff rate. The requirement follows an executive order sig…
    Endpoints · 6mo agoRegulatoryNeutral↗ source
  • Penn Medicine to Leverage $1.1 Million AI Grant for Doctor Training Program
    Penn Medicine announced plans to incorporate artificial intelligence into its physician education efforts after receiving a $1.1 million grant from an education grant program in January. The grant…
    Endpoints · 6mo agoNeutral↗ source
  • iECURE’s early gene-therapy success in a baby fails to replicate in larger trial
    Early last year iECURE reported that its experimental gene therapy appeared to cure an infant suffering from a severe genetic disorder. The company has now released data from a follow-up study tha…
    Endpoints · 6mo agoNegative readoutNegative↗ source
  • FDA leadership gap deepens uncertainty for biotech as acting officials take charge
    Marty Makary's resignation as FDA commissioner has left the agency without a permanent head. Kyle Diamantas is serving as the temporary leader, while three senior drug-review positions are filled b…
    BioPharma Dive · 6mo agoRegulatoryNegative↗ source
  • Lilly data show lower-dose GLP-1 injections and oral pill help sustain weight loss
    Eli Lilly presented new research on how patients who have lost weight with GLP‑1 medicines can maintain that loss over time. The studies followed people who had achieved significant reductions usin…
    BioPharma Dive · 6mo agoPositive readoutPositive↗ source
  • Assertio rejects Garda bid, accepts Zydus offer valuing company at $23.50 per share
    Assertio Holdings announced it has terminated its pending acquisition by Garda Therapeutics after the board approved a higher offer from another suitor. The new proposal from Zydus Worldwide value…
    BioPharma Dive · 6mo agoDealNeutral↗ source
  • Takeda plans to cut 4,500 jobs, about 9% of workforce, under new CEO's restructuring plan
    Takeda announced it will eliminate roughly 9% of its global workforce, affecting about 4,500 positions, over the coming fiscal year. The cuts are part of a restructuring effort that began under th…
    Endpoints · 6mo agoLayoffsNegative↗ source
  • Valneva to cut up to 15% of workforce as travel slowdown lowers vaccine demand
    Valneva, a French vaccine developer, announced it will lay off between 10% and 15% of its employees. The cuts are linked to a decline in demand for travel vaccines, which the company says is drive…
    Endpoints · 6mo agoLayoffsNegative↗ source
  • Abeona shifts from eye gene therapy to solid tumor T‑cell programs as AstraZeneca’s rare disease drug clears Phase 3
    Abeona Therapeutics announced it is ending its eye‑focused gene‑therapy projects and will redirect resources toward developing T‑cell based treatments for solid tumors. The company says the pivot…
    Endpoints · 6mo agoPositive readoutPositive↗ source
  • Tessera Therapeutics reports infusion gene edit corrects 85% of blood cells in sickle cell study
    Tessera Therapeutics announced new data from its in-vivo gene editing program targeting sickle cell disease. The experimental therapy is given as a simple infusion, avoiding the complex cell engin…
    Endpoints · 6mo agoPositive readoutPositive↗ source
  • Podcast Highlights Community Oncology’s Growing Role in U.S. Cancer Care
    A new sponsored podcast episode explores how community oncology clinics are becoming a vital part of the U.S. cancer‑care landscape. The program, released in May 2026, discusses why these local cen…
    BioPharma Dive · 6mo agoPositive↗ source
  • Merck KGaA sees client stockpiling of lab equipment amid Iran war, lifts guidance
    Merck KGaA's CFO Helene von Roeder said the company is observing a rise in demand for its laboratory equipment as customers increase inventories in response to the ongoing war in Iran. The heighte…
    Endpoints · 6mo agoPositive↗ source
  • FDA Commissioner Marty Makary Ousted After Trump-Backed Action
    The piece reports that Marty Makary, who had been serving as FDA commissioner, is no longer in the role. His removal came after headlines emerged that President Donald Trump had signed a measure…
    Endpoints · 6mo agoRegulatoryNegative↗ source
  • Lakefront Biotherapeutics rebrands from Galapagos as it seeks turnaround from Chicago office
    Lakefront Biotherapeutics, formerly known as Galapagos, announced a rebranding effort aimed at reviving the company’s fortunes. The change reflects a strategic shift as the firm looks to reposition…
    Endpoints · 6mo agoNeutral↗ source