Solid Biosciences Gets FDA Fast Track on Treatment for Heart Rhythm Disorder

 Solid Biosciences said federal regulators have granted its fast-track designation for the company's investigational gene therapy for the treatment of a heart rhythm condition.

The Food and Drug Administration gave the designation to SGT-501, which is being developed to treat catecholaminergic polymorphic ventricular tachycardia, the Charlestown, Mass., company said.

The FDA's fast-track designation facilitates development and expedites the review of drugs that treat serious or life-threatening conditions and have the potential to fill unmet medical needs.

Earlier this month, the FDA granted investigational new drug clearance for SGT-501. A Phase 1b trial to test the safety and efficacy of the therapy is expected to start in the fourth quarter.

https://www.morningstar.com/news/dow-jones/202507235397/solid-biosciences-gets-fda-fast-track-on-treatment-for-heart-rhythm-disorder