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Investing.com - BofA Securities maintained its Neutral rating and $20.00 price target on Sarepta Therapeutics (NASDAQ:SRPT) following the company’s announcement about an FDA safety request. The stock has fallen nearly 90% over the past year, with particularly steep declines following recent safety concerns. According to InvestingPro data, the company’s RSI suggests the stock is currently in oversold territory.
Sarepta reported Friday that the Food and Drug Administration informally requested a voluntary halt to all shipments of its gene therapy Elevidys. Despite this request, the company plans to continue shipments to ambulatory patients, citing a favorable risk/benefit profile for this population.
The company has already voluntarily paused shipments to non-ambulatory patients following reports of acute liver failure that resulted in three patient deaths. Sarepta emphasized these cases were limited to more advanced, older patients and stated it remains committed to evaluating a new immunosuppressive regimen with sirolimus to mitigate this risk.
Sarepta plans to continue engaging with regulators to update the Elevidys label for ambulatory patients to include a black box warning. No formal request has been made by the FDA to remove the therapy from the market.
BofA Securities expects Elevidys uptake will be more limited following these recent reports but believes the therapy will remain available for now, maintaining its Neutral rating and $20 price target while monitoring for any further regulatory action. With analyst targets ranging from $9 to $110, market sentiment remains mixed. Get comprehensive analysis and 13 additional key insights about Sarepta with an InvestingPro subscription.
In other recent news, Sarepta Therapeutics is facing significant challenges following the FDA’s request to halt shipments of its gene therapy, Elevidys, after a patient death in its limb-girdle muscular dystrophy program. Despite this, Wells Fargo (NYSE:WFC) maintained its Overweight rating with a $65.00 price target, highlighting the resilience of Elevidys’ ambulatory indication. In contrast, JPMorgan lowered its price target to $20.00 from $28.00, citing a conservative modeling approach and regulatory developments. Mizuho (NYSE:MFG) downgraded Sarepta from Outperform to Neutral, reducing its price target to $14.00 due to safety concerns with the company’s AAVrh74 platform vector. William Blair reiterated a Market Perform rating, noting minimal impact on Sarepta’s clinical holds but projecting a full-year 2025 net loss of $233 million. BMO Capital also maintained a Market Perform rating, with a $50.00 price target, following a survey revealing investor concerns about Sarepta’s future and management credibility. These developments suggest a complex regulatory environment and investor uncertainty surrounding Sarepta’s gene therapy treatments.
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