Therapeutic or Preventive Procedure
Otsuka’s Phase 3 IgAN Win with Sibeprenlimab Shakes Vera’s Stock
Otsuka; sibeprenlimab; IgA nephropathy; phase 3 trial; proteinuria reduction; Vera Therapeutics; stock drop; kidney disease; UPCR; FDA Priority Review
Biotech Leaders Urge FDA to ‘Modernise’ Regulation to Compete with China
FDA; biotech; regulation; modernization; China; cell and gene therapy; CEO roundtable; competitiveness; innovation
Corcept Highlights Survival Benefit Despite ALS Trial’s Missed Primary Endpoint
Corcept Therapeutics; dazucorilant; ALS; amyotrophic lateral sclerosis; DAZALS trial; survival benefit; phase 2 study; ALSFRS-R; ENCALS 2025
Regenxbio Reports Consistent One-Year Benefit for DMD Gene Therapy RGX-202
Regenxbio; DMD; Duchenne muscular dystrophy; RGX-202; gene therapy; AFFINITY DUCHENNE trial; clinical trial; microdystrophin; biomarker; phase I/II; functional data
Cullinan Inks $700M Deal for BCMA Bispecific to Expand Autoimmune T-Cell Engager Portfolio
Cullinan Therapeutics; Genrix Bio; BCMA bispecific; velinotamig; T-cell engager; autoimmune disease; CD19xCD3; CLN-978; multiple myeloma; clinical development; biotech partnerships
Forging the Future of Cell Therapy: Bayer and BlueRock’s Unique Journey
cell therapy; Bayer; BlueRock Therapeutics; Parkinson’s disease; bemdaneprocel; biotech partnerships; RMAT designation; Phase 3 trials; regenerative medicine
Sarepta’s rAAVrh74 Viral Vector Receives FDA Platform Technology Designation for Gene Therapy
Sarepta Therapeutics; FDA; platform technology designation; rAAVrh74 viral vector; gene therapy; SRP-9003; limb-girdle muscular dystrophy; rare diseases
Gilead Bolsters Trodelvy in Triple-Negative Breast Cancer With Practice-Changing Keytruda Combo Win
Gilead Sciences; Trodelvy; Keytruda; triple-negative breast cancer; TNBC; antibody-drug conjugate; immunotherapy; progression-free survival; ASCO 2025; phase 3 trial; practice-changing; combination therapy
Actuate Therapeutics’ Pancreatic Cancer Drug Elraglusib Shows Survival Benefit in Phase 2 Study
Actuate Therapeutics; Elraglusib; Pancreatic cancer; Phase 2 trial; Median overall survival; Gemcitabine; Nab-paclitaxel; Metastatic pancreatic ductal adenocarcinoma; Survival benefit; ASCO 2025
BioAge Signs Option Agreement for Obesity Asset from Chinese Biotech Following APJ Agonist Setback
BioAge; JiKang Therapeutics; obesity; APJ agonist; option agreement; nanobody; small molecule agonists; exercise mimetic; incretin therapy; metabolic diseases