Capsida Receives FDA Fast Track Designation for Its Potential First-in-Class IV-Administered Gene Therapy for STXBP1 Developmental and Epileptic Encephalopathy Capsida previously received FDA ...

CAP-002 is the company’s investigational IV-administered gene therapy for the treatment of STXBP1 developmental and epileptic encephalopathy (STXBP1-DEE), and is the first IV-delivered ...

CAP-002 is the company’s investigational IV-administered gene therapy for the treatment of STXBP1 developmental and epileptic encephalopathy (STXBP1-DEE), and is the first IV-delivered, AAV blood ...

STXBP1-DEE is estimated to affect up to one in 26,000 births globally, equating to approximately 5,000 pediatric patients in U.S. and Europe. The STXBP1 protein is present in every neuron and is ...

The U.S. Food and Drug Administration has cleared the Investigational New Drug (IND) application for CAP-002, Capsida Biotherapeutics’ first-in-class, intravenously (IV) administered gene therapy for ...

Capsida Biotherapeutics Inc. has gained IND clearance from the FDA for CAP-002, its first-in-class, intravenously administered gene therapy for syntaxin-binding protein 1 developmental and epileptic ...

CAP-002 is the first engineered IV-delivered gene therapy that crosses the blood-brain-barrier and detargets the liver and dorsal root ganglia to enter the clinic THOUSAND OAKS, Calif., May 12 ...

The three-month cohort data from the NHP GLP toxicology study demonstrate dose-dependent brain-wide expression of STXBP1 and simultaneous detargeting of the liver and dorsal root ganglia (DRGs).