Sarepta stock halts Elevidys shipments amid FDA label update for liver risks

Published 22/07/2025, 16:50
Sarepta stock halts Elevidys shipments amid FDA label update for liver risks

Investing.com - Sarepta Therapeutics (NASDAQ:SRPT), which has seen its stock plummet nearly 90% year-to-date according to InvestingPro data, announced it will voluntarily suspend all U.S. shipments of Elevidys, its treatment for Duchenne muscular dystrophy (DMD), beginning July 23.

The temporary suspension will allow the company to provide required information to the FDA to complete an Elevidys label update, which is expected to include a black box warning for acute liver injury (ALI) and acute liver failure (ALF). Despite these challenges, InvestingPro data shows the company maintains a healthy current ratio of 4.02, indicating strong ability to meet short-term obligations.

TD Cowen maintained its Hold rating and $28.00 price target on Sarepta stock following the announcement, noting that the decision would enable a more collaborative approach to the label update process.

The research firm estimates the shipment pause could last approximately 3-6 months, potentially defined by the time needed for Sarepta to conduct its planned sirolimus pre-treatment cohort and discuss findings with regulators.

No specific timeline for resuming shipments was provided by the company, which opted for voluntary suspension rather than facing potential regulatory enforcement that could have resulted in a longer disruption to treatment availability. With a market capitalization of $1.3 billion and analysts maintaining mixed sentiment, investors can access comprehensive analysis and 14 additional key insights through InvestingPro’s detailed research reports.

In other recent news, Sarepta Therapeutics has announced a temporary pause in shipments of its drug Elevidys in the United States. This decision comes in response to regulatory concerns and requests for further information from the Food and Drug Administration (FDA). The pause follows similar actions by Children’s Hospital Los Angeles, which had already halted the use of Elevidys due to regulatory uncertainties. In light of these developments, BMO Capital lowered its price target for Sarepta from $50.00 to $25.00, maintaining a Market Perform rating. Piper Sandler also reduced its price target from $18.00 to $11.00, while continuing to rate the stock as Neutral. Additionally, Barclays (LON:BARC) downgraded Sarepta from Overweight to Equalweight, adjusting its price target from $32.00 to $18.00, citing safety concerns after a third patient death linked to the company’s AAVrh74 platform. Barclays noted investor dissatisfaction due to Sarepta’s decision not to publicly disclose the incident. These updates reflect ongoing challenges for Sarepta as it navigates regulatory and safety issues.

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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