Shares of Sarepta Therapeutics (SRPT) jumped over 14% on Tuesday after the FDA authorized the company to restart shipments of its gene therapy for certain Duchenne muscular dystrophy (DMD) patients. SRPT stock has recovered some of its recent losses but remains down over 80% year-to-date.
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FDA Reversal Brings Relief for Sarepta
On Monday, the FDA recommended partially lifting the hold on Elevidys shipments. The FDA had used a few rare deaths in patients with advanced DMD as a reason to reconsider the drug’s approval and potentially remove it from the market. Now, the agency states that boys who can still walk independently are eligible to receive the gene therapy. This decision aligns with the existing evidence showing the treatment’s benefits outweigh the risks. Back in June, the company had paused the use of the therapy in boys who could no longer walk while it investigated the safety concerns.
Recently, SRPT stock dropped sharply after the FDA asked Sarepta to stop all Elevidys shipments. The decision came after the therapy was linked to two patient deaths, raising safety concerns. In response, the company voluntarily paused U.S. shipments of the treatment. For context, Elevidys is a one-time gene therapy for DMD in patients aged four and older, and it makes up about half of Sarepta’s total revenue.
What Is the Price Prediction for SRPT?
According to TipRanks, Wall Street has a Hold consensus rating on SRPT stock, based on five Buys, 19 Holds, and five Sells assigned in the last three months. The average Sarepta Therapeutics stock price target of $21.68 implies a 37% upside potential.
