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Investing.com - Sarepta Therapeutics (NASDAQ:SRPT) announced Tuesday it will temporarily pause all U.S. shipments of its drug Elevidys, effective at the close of business Tuesday. The news has intensified the stock’s recent decline, with InvestingPro data showing a steep 27% drop in the past week alone, pushing shares near their 52-week low of $12.60.
The company’s decision follows an update from Children’s Hospital Los Angeles, which had already halted use of Elevidys due to regulatory uncertainty while awaiting further direction from the Food and Drug Administration.
This pause comes just days after Sarepta had initially refused to comply with the FDA’s request to withdraw the drug, marking what analysts describe as a significant reversal in the company’s position.
H.C. Wainwright maintained its Sell rating on Sarepta stock with a $0 price target, suggesting the "voluntary" pause likely anticipates an inevitable FDA mandate to remove the drug from market.
The investment firm noted that concerns about Elevidys have escalated beyond questions about its efficacy to include what they characterized as "real risk of death for DMD patients," predicting the FDA will ultimately remove the drug from the market completely.
In other recent news, Sarepta Therapeutics is facing significant challenges following a series of developments. The U.S. Food and Drug Administration (FDA) has placed a clinical hold on Sarepta’s investigational gene therapy trials for limb girdle muscular dystrophy (LGMD), affecting several programs including SRP-9003, SRP-9004, SRP-6004, and SRP-9005. This decision comes after Sarepta had already paused most of these programs as part of a strategic restructuring, with the exception of SRP-9003. Barclays (LON:BARC) downgraded Sarepta’s stock from Overweight to Equalweight, citing safety concerns and a lack of transparency regarding a third patient death associated with the company’s AAVrh74 platform. Similarly, Piper Sandler reduced its price target for Sarepta, maintaining a Neutral rating, following the FDA’s request to halt shipments of Elevidys for all patients, which the company refused for ambulatory patients. Cantor Fitzgerald also maintained a Neutral rating on Sarepta, noting transparency concerns as the company approaches 1,000 patients treated with its therapies. Sarepta plans to engage with the FDA to discuss a potential pathway for submitting a Biologics License Application for SRP-9003, seeking accelerated approval once the hold is lifted.
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