Oppenheimer downgrades Sarepta to Perform as EMBARK misses primary endpoint

As previously reported, Oppenheimer downgraded Sarepta to Perform from Outperform after the company Sarepta Phase 3 results from pivotal trial EMBARK for SRP-9001 and followed up with an investor presentation on 10/30. While the headline is that the primary endpoint missed statistical significance, management believes that Elevidys can yet be fully approved for a broader label of DMD boys than current. Oppenheimer believes this view has some merit, but steps to the sidelines pending greater clarity on FDA discussions/feedback, timelines for potential full approval, a full safety dataset to be presented at a medical conference next year, and more insight into potential label expansion in all ages regardless of ambulation.