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Solid Biosciences Gets FDA, Health Canada Clearance to Advance Gene Therapy Trial for Cardiac Disease
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Solid Biosciences Gets FDA, Health Canada Clearance to Advance Gene Therapy Trial for Cardiac Disease
Jul 8, 2025 1:46 PM

04:25 PM EDT, 07/08/2025 (MT Newswires) -- Solid Biosciences ( SLDB ) said late Tuesday it received approval for its investigational new drug application from the US Food and Drug Administration and clinical trial application from Health Canada for SGT-501, a gene therapy to treat catecholaminergic polymorphic ventricular tachycardia, a rare, life-threatening genetic heart rhythm disorder.

The company said it plans to commence a phase 1b clinical trial to assess the safety, tolerability, and efficacy of SGT-501 in Q4.

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