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Investing.com - Citi has reiterated its Sell rating and $7.00 price target on Sarepta Therapeutics (NASDAQ:SRPT) following reports of regulatory challenges for the company’s gene therapy. The stock, currently trading at $12.88, has fallen over 91% in the past year, according to InvestingPro data.
Endpoints News reported that Center for Biologics Evaluation and Research (CBER) reviewers unanimously agreed that Elevidys should not return to market, according to Citi analyst Yigal Nochomovitz.
The FDA reviewers indicated that Sarepta would need to conduct new studies to demonstrate an appropriate safety profile for the gene therapy before it could be reconsidered for market approval.
While Sarepta had previously stated that a third patient death involving a limb-girdle muscular dystrophy (LGMD) patient was unrelated to liver toxicity, FDA officials reportedly see a clear connection among all three fatalities, including two Duchenne muscular dystrophy (DMD) patients.
Citi maintains its position that Elevidys is unlikely to return to the market, citing the identical AAV serotype and acute liver failure observed across the three patient deaths as factors in the regulatory assessment. Eight analysts have recently revised their earnings estimates downward, with comprehensive analysis available in the InvestingPro Research Report, which provides detailed insights on this and 1,400+ other US stocks.
In other recent news, Sarepta Therapeutics has faced significant developments concerning its Duchenne muscular dystrophy treatment, Elevidys. The company announced a voluntary suspension of all U.S. shipments of Elevidys to update the product’s label, which is expected to include a black box warning for acute liver injury and failure. This comes as the FDA’s Center for Biologics Evaluation and Research expressed unanimous agreement that Elevidys should not return to the market without new studies.
Further complicating the situation, Citi has initiated a 90-day downside catalyst watch on Sarepta, citing concerns over the company’s gene therapy programs, including Elevidys. Additionally, Citi initiated coverage on Sarepta with a Sell rating due to substantial forward risks and potential safety issues. Freedom Broker also downgraded Sarepta from Buy to Hold, reducing its price target significantly due to safety concerns and inconsistent statements about Elevidys sales. These recent developments have raised questions about the company’s management and future prospects.
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