Sarepta Therapeutics (NASDAQ:SRPT) soared in trading after the company announced that the U.S. Food and Drug Administration (FDA) had granted accelerated expansion to the labeled indication for Elevidys (delandistrogene moxeparvovec-rokl).
Details of the FDA’s Approval for Sarepta’s Gene Therapy
This approval of Elevidys will include individuals with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene who are at least 4 years of age. DMD is a genetic disorder characterized by progressive muscle degeneration.
The FDA granted traditional approval for ambulatory patients and accelerated approval for non-ambulatory patients. Sarepta stated that the FDA’s continued approval may be dependent on the “verification of clinical benefit in a confirmatory trial.”
Accordingly, Sarepta has committed to conducting and submitting the results of a randomized, controlled trial to verify and confirm the clinical benefit of Elevidys in patients with DMD who are non-ambulatory.
Analysts Perceive an Upside to Elevidys Approval
According to the TipRanks “Bulls Say,Bears Say,” analysts bullish on SRPT stock believe that Elevidys’s gene therapy is unlikely to have any competition “and there is a potential upside to Elevidys sales forecast and consensus estimates.”
What Is the SRPT Stock Target?
Analysts remain bullish about SRPT stock, with a Strong Buy consensus rating based on 13 Buys and two Holds. Year-to-date, SRPT has soared by more than 60%, and the average SRPT price target of $166.20 implies an upside potential of 2.6% from current levels.
