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- SGT-501 is a novel gene therapy for rare, life-threatening, genetic arrhythmogenic disease with no approved therapies - - SGT-501 has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA - - Solid expects to initiate Phase 1b clinical trial of SGT-501 in the fourth quarter of 2025 - - Expands Solid's clinical pipeline to include first cardiac indication with urgent unmet medical need - CHARLESTOWN, Mass., July 08, 2025 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB) (the “Company” or “Solid”), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today announced approval of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) and clinical trial application (CTA) by Health Canada for SGT-501, a novel gene therapy approach for the treatment of catecholaminergic polymorphic ventricular tachycardia (CPVT), a highly malignant, arrhythmogenic channelopathy caused by genetic mutations that impact the ryanodine receptor (RYR2) in cardiac muscle.
