Community Letter: EMBARK Part 1 Topline Results

Sarepta Therapeutics announced topline results from EMBARK, a global Phase 3 pivotal study of ELEVIDYS micro-dystrophin gene therapy for Duchenne muscular dystrophy patients between the ages of 4 through 7 years.

We are disappointed that the primary endpoint was not met, but encouraged by the statistically significant results on key pre-specified secondary endpoints.

Sarepta has communicated their expectation that the FDA will consider the totality of the data that speaks to the potential benefit in some patient populations and a commitment to this therapy and serving the Duchenne community.

Read more in Sarepta’s letter to the community