Dyne Therapeutics, which received early funding from CureDuchenne, is initiating a Phase 3 FORZETTO Trial of z-rostudirsen in individuals with Duchenne amenable to skipping exon 51. Dyne is on track to submit a BLA to the FDA for accelerated approval in the US later this quarter, and the FORZETTO trial is intended to serve as a confirmatory trial in the US and support ex-US approvals.
Link to the press release: here
The post Dyne initiates global Phase 3 trial in Duchenne amenable to skipping exon 51, ahead of planned FDA submission for accelerated approval in the US appeared first on CureDuchenne.