Solid Biosciences shares positive regulatory updates

Solid Biosciences shared that they have aligned with the US FDA on the overall design of a Phase 3 randomized, double-blind, placebo-controlled trial for SGT-003, a micro-dystrophin gene therapy for Duchenne.  Solid also indicated that they will have additional meetings with the FDA regarding a potential accelerated approval pathway for SGT-003.

In the meantime, Solid’s Phase 1/2 trial is ongoing, with 36 participants dosed so far.  The Company anticipates that Phase 3 will begin dosing before the end of Q1. 

Link to press release HERE