Sarepta stock jumps as FDA may lift ELEVIDYS pause after safety review

Published 29/07/2025, 14:42
Sarepta stock jumps as FDA may lift ELEVIDYS pause after safety review

Investing.com - Sarepta Therapeutics (NASDAQ:SRPT) stock surged approximately 48% in after-hours trading after the company announced the FDA may lift its voluntary pause on ELEVIDYS shipments for ambulatory Duchenne muscular dystrophy (DMD) patients. The surge comes as welcome news for investors, as InvestingPro data shows the stock had fallen nearly 90% over the past year, with particularly high volatility.

The FDA’s potential decision follows its review of an 8-year-old ELEVIDYS patient’s death in Brazil, which regulators determined was "unlikely related to the therapy," according to Cantor Fitzgerald.

Cantor Fitzgerald maintained its Neutral rating and $14.00 price target on Sarepta following the announcement, noting the development "theoretically removes the worst-case scenario on the stock."

While Cantor Fitzgerald expects ELEVIDYS sales to decline, the firm believes Sarepta will still generate sufficient revenue from the therapy to address its convertible notes obligations.

The resumption of shipments would also allow Sarepta to pay its owed milestones to Arrowhead Pharmaceuticals (NASDAQ:ARWR), according to the research note. For deeper insights into Sarepta’s financial health and additional ProTips, check out the comprehensive research report available on InvestingPro.

In other recent news, Sarepta Therapeutics has seen a series of significant developments. The FDA’s decision to lift the voluntary hold on Sarepta’s Elevidys treatment in ambulatory patients has led to several adjustments in analyst ratings and price targets. Piper Sandler raised its price target for Sarepta to $15, maintaining a Neutral rating. Similarly, BMO Capital increased its price target to $50, also maintaining a Market Perform rating. H.C. Wainwright raised its price target from $0 to $5, though they continue to hold a Sell rating, citing challenges in the uptake of the Elevidys treatment. Bernstein initiated coverage with a Market Perform rating and a $13 price target amid ongoing challenges for the company. JPMorgan upgraded Sarepta’s stock from Underweight to Neutral, setting a price target of $24 following the FDA’s recommendation to resume Elevidys shipments. These developments reflect the complexities surrounding Sarepta’s current business environment.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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