fda-and-biotech News
Eli Lilly's Jaypirca Outperforms J&J's Imbruvica in Leukemia Trial
Phase 3 study shows Lilly's next-generation cancer drug has a superior response rate and a better safety profile, posing a direct challenge to a blockbuster incumbent.
Arcellx Shares Surge on Strong Multiple Myeloma Drug Data
Updated Phase 2 results for anito-cel show a 96% response rate, positioning the therapy as a potential best-in-class treatment and challenging established rivals.
Fulcrum Therapeutics Stock Soars 60% on Promising Sickle Cell Data
Phase 1b results for oral drug pociredir show significant fetal hemoglobin increases, fueling investor optimism for a new treatment pathway.
Structure Therapeutics Stock Doubles on 'Homerun' Obesity Pill Data
Positive Phase 2b results for oral drug aleniglipron position the biotech as a contender in the lucrative weight-loss market dominated by injectable treatments.
Kamada Halts Phase 3 Trial, Shares Tumble Despite Rosy Outlook
The Israeli biopharma company's stock fell nearly 5% after it discontinued its inhaled therapy trial for AAT Deficiency, a key pipeline candidate.
Recursion Climbs After Positive Trial Data for FAP Drug
Phase 1b/2 results for its lead oncology asset, REC-4881, showed rapid and durable reductions in polyp burden, a key validation for its AI-driven drug discovery platform.
Structure Therapeutics Stock Doubles on Promising Oral Weight-Loss Drug Data
Phase 2b results for aleniglipron show competitive efficacy, setting the stage for a Phase 3 trial in the lucrative GLP-1 market dominated by injectable treatments.
Cullinan Therapeutics Surges on Promising Leukemia Drug Data
Phase 1 results for its novel T-cell engager, CLN-049, showed a 31% complete response rate in heavily pretreated AML patients, bolstering analyst confidence.