Dyne Therapeutics’ z-rostudirsen Wins Priority Review for Duchenne Muscular Dystrophy
Dyne Therapeutics' z-rostudirsen wins Priority Review for Duchenne muscular dystrophy, compressing FDA evaluation to six months for exon 51...
Akeso Doses First Patient in AK146D1 Phase II Study for Advanced NSCLC
Akeso doses first patient in AK146D1 Phase II Study for advanced NSCLC, combining dual-target ADC with ivonescimab immunotherapy.
Arletta Pharma Advances Lybrido for Female Sexual Desire Disorder With FDA Backing
Arletta Pharma's Lybrido for female sexual desire disorder advances with FDA backing for a single-trial Phase 3 pathway.
Neurizon Completes NUZ-001 ALS Trial Enrollment, Advances Results to Q2 2027
Neurizon completes NUZ-001 ALS Trial enrollment of 250 patients in five months, with topline results expected in late Q2...
FDA Clears IND for Umoja’s UB-VV400 In Vivo CAR T Therapy
FDA clears IND for Umoja's in vivo CAR T therapy UB-VV400, targeting relapsed B cell malignancies with a single...
RT-114 Achieves Oral Bioavailability Exceeding Subcutaneous Dose in Phase 1a
RT-114 oral bioavailability exceeded subcutaneous dosing by over 150% in Phase 1a, marking a significant advance for GLP-1 delivery.
Allogene’s ALLO-316 Achieves 31% Response Rate in Advanced Renal Cell Carcinoma
ALLO-316 achieves 31% response rate in advanced renal cell carcinoma patients previously resistant to checkpoint inhibitors and tyrosine kinase...
59% of Clinical Trial Sites Losing Eligible Patients to Process Inefficiencies
59% of clinical trial sites lose eligible patients due to process inefficiencies rather than patient scarcity, revealing a throughput...
ORIC Initiates Himalayas-1 Phase 3 Trial of Rinzimetostat for mCRPC
ORIC initiates Himalayas-1 Phase 3 trial of rinzimetostat plus darolutamide in 600 mCRPC patients previously treated with abiraterone.
Hemab’s Sutacimig Cuts Bleeds 84% in Phase 2 Glanzmann Thrombasthenia Study
Hemab's sutacimig cut treated bleeds 84% in Phase 2 Glanzmann Thrombasthenia study, advancing weekly subcutaneous prophylaxis toward Phase 3...