June 25, 2025 – Talk Bio

FDA Investigates Patient Deaths Linked to Sarepta’s Elevidys Gene Therapy for Duchenne Muscular Dystrophy

5 days ago talkbio0Tagged ELEVIDYS, Evaluation, gene therapy, Liver, Liver Failure, Acute, Muscular Dystrophy, Duchenne, patient deaths, regulatory, Toxicity aspects, Unable to walk (finding), United States Food and Drug Administration

FDA; Sarepta; Elevidys; Duchenne muscular dystrophy; gene therapy; patient deaths; acute liver failure; liver toxicity; regulatory investigation; non-ambulatory patients

Kymera Faces Sanofi Setback but Secures $750M Gilead Oncology Deal

5 days ago talkbio0Tagged CDK2 protein, human, Gilead, Kymera, Molecular Glue Degrader, Neoplasms, protein degrader, sanofi

Kymera; Sanofi; Gilead; molecular glue degrader; CDK2; oncology; deal; protein degrader

Leap Therapeutics Slashes 75% of Workforce, Ends Clinical Trial, Considers Strategic Options

5 days ago talkbio0Tagged Biotech Layoffs, Clinical Trials, FL-501, Flatulence, LEAP, Sirexatamab, strategic alternatives

Leap Therapeutics; workforce reduction; biotech layoffs; clinical trial; strategic alternatives; sirexatamab; FL-501; R&D wind down

Nektar Declares Phase IIb Eczema Win for Rezpeg, but Analysts Remain Skeptical

5 days ago talkbio0Tagged analysts, Clinical Trials, Dermatitis, Atopic, Dupixent, EASI, Eczema, Lilly partnership, Nektar Therapeutics, Phase II B Trial, Rezpeg, Rezpegaldesleukin, Score, Skepticism

Nektar Therapeutics; Rezpegaldesleukin; Rezpeg; Phase IIb trial; eczema; atopic dermatitis; clinical trial; EASI score; Dupixent; analyst skepticism; Lilly partnership

Nuvalent Reports Positive Pivotal Data for ROS1-Targeted Lung Cancer Drug; Rolling FDA Submission Planned

6 days ago talkbio0Tagged ARROS-1 trial, Frequency of Responses, Metastatic malignant neoplasm to brain, Neoplasms, Non-Small Cell Lung Carcinoma, Nuvalent, Protein-tyrosine kinase inhibitor, ROS1-positive Lung Cancer, Submission, United States Food and Drug Administration, zidesamtinib

Nuvalent; ROS1-positive lung cancer; zidesamtinib; FDA submission; ARROS-1 trial; NSCLC; tyrosine kinase inhibitor; objective response rate; brain metastases; oncology

BrightGene’s Dual GLP-1/GIP Agonist BGM0504 Shows Promise in Phase 2 Diabetes and Obesity Trials at ADA25

6 days ago talkbio0Tagged ADA25, BGM0504, BrightGene, Diabetes Mellitus, Non-Insulin-Dependent, GLP-1/GIP agonist, Glycosylated hemoglobin A, Obesity, semaglutide, Weight maintenance regimen

BrightGene; BGM0504; GLP-1/GIP agonist; ADA25; Type 2 diabetes; Obesity; Phase 2 clinical trial; weight management; HbA1c reduction; semaglutide; tirzepatide