Oppenheimer Sees Sarepta (SRPT) Dystrophin Data Submission by June 30

Oppenheimer analyst Christopher Marai reiterated an Outperform rating and $60 price target on Sarepta Therapeutic (NASDAQ: SRPT) noting the company entered a quiet period Friday, indicating that analysis/submission of dystrophin data (Western blot) from 48-week biopsies of 13 PROMOVI patients to the FDA is imminent. They expect submission by June 30.

"We've previously noted that analysis can be accomplished within ~3 weeks, consistent with 180-wk biopsy analysis," the analyst commented. "On June 6, Sarepta announced that FDA requested dystrophin data."

The firm continues to anticipate accelerated approval following PROMOVI 48-week biopsies, confirming stat-sig increases of dystrophin on the order of ~0.9% vs. baseline.

"The FDA's request for additional dystrophin data suggests FDA is convinced that dystrophin levels previously demonstrated (~0.9% of normal) will be adequate for accelerated approval; although it's possible slightly younger PROMOVI patients may respond better to treatment, there is no scientific basis for believing PROMOVI biopsies will result in substantially numerically different dystrophin levels," Maria commented.

For an analyst ratings summary and ratings history on Sarepta Therapeutic click here. For more ratings news on Sarepta Therapeutic click here.

Shares of Sarepta Therapeutic closed at $17.36 yesterday.

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