Solid Biosciences Receives FDA Fast Track Designation for SGT-501 First-in-Class Gene Therapy for Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Solid Biosciences Inc., which acquired UF startup AavantiBio, announced that it received Fast Track designation from the U.S. Food and Drug Administration (FDA) for SGT-501, the Company’s novel, AAV-based investigational gene therapy for the treatment of catecholaminergic polymorphic ventricular tachycardia (CPVT).
Solid Biosciences Announces FDA IND and Health Canada CTA Approval for First-in-Class Cardiac Gene Therapy To Treat Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Solid Biosciences, which acquired UF startup AavantiBio, announced FDA and Health Canada approval to begin clinical trials of SGT-501, a gene therapy targeting CPVT, a severe heart rhythm disorder caused by RYR2 mutations.