Solid Biosciences (SLDB) announced approval of its investigational new drug application by the FDA and clinical trial application by Health Canada for SGT-501, a novel gene therapy approach for the treatment of catecholaminergic polymorphic ventricular tachycardia, a highly malignant, arrhythmogenic channelopathy caused by genetic mutations that impact the ryanodine receptor in cardiac muscle. The company expects to initiate a Phase 1b clinical trial to evaluate the safety, tolerability and efficacy of SGT-501 in the fourth quarter of 2025.
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