Sarepta Therapeutics, a Massachusetts-based biopharmaceutical company, announced on Friday that the US Food and Drug Administration (FDA) has granted Priority Review status to its Efficacy Supplement related to Elevidys, a drug intended to treat Duchenne muscular dystrophy (DMD). Following the announcement, Sarepta's shares experienced a significant surge, increasing by 14% in the pre-market exchange.
The FDA's Priority Review status is meant to quicken the approval process of Elevidys, potentially broadening its application for the treatment of DMD patients with a confirmed mutation in the DMD gene. This could also facilitate the transitioning of Elevidys from an accelerated approval to an entirely traditional approval.
Sarepta disclosed that the FDA has planned the target goal review date for June 21, 2024. However, the FDA clarified that there are no plans for an advisory committee meeting to debate on the supplement.
Meanwhile, in the pre-market activity on the Nasdaq, Sarepta Therapeutics' shares were seen trading at $143.01, marking a rise of approximately 14.51%.
