Sarepta Therapeutics Shares Drop 10% Following New Liver Injury Report for Gene Therapy Elevidys
Key Insights
Sarepta Therapeutics shares fell 10% after a new FDA adverse event report documented drug-induced liver injury (search) and elevated liver enzymes in a patient treated with gene therapy Elevidys.
The company stated the patient case was previously disclosed in safety updates and was classified as serious only due to hospitalization for IV steroid treatment, to which the patient responded well.
Deutsche Bank (search) maintains a Sell rating with a $12 price target, citing ongoing safety and regulatory concerns surrounding Elevidys amid previous reports of patient death and clinical study halts.
Sarepta Therapeutics (NASDAQ: SRPT) experienced a significant 10% decline in share price following the emergence of a new adverse event report in the FDA Adverse Event Reporting System for its gene therapy Elevidys. The report documented a patient experiencing drug-induced liver injury (search) and increased alanine transaminase/aspartate transaminase levels, categorized as a serious adverse event and logged on August 22, apparently originating from Russia.
Company Response to Safety Concerns
Sarepta management clarified to Deutsche Bank (search) that the patient case was already disclosed in the safety update provided to the patient community and in the company's Citizen Petition response. The case was classified as serious solely because the patient required hospitalization to receive IV steroids, according to the company. Management emphasized that the patient responded well to the steroid treatment.
Ongoing Safety Scrutiny for Gene Therapy
The latest adverse event report adds to mounting safety concerns surrounding Elevidys, which has faced significant regulatory scrutiny. In March 2025, Sarepta announced that a patient had died following treatment with Elevidys, resulting in a substantial drop in stock price. The company has subsequently disclosed halts in recruitment and dosing in clinical studies, continuing to impact stock performance.
Analyst Outlook and Legal Implications
Deutsche Bank (search) maintains a Sell rating on Sarepta with a $12 price target, reflecting ongoing concerns over safety and regulatory risks associated with Elevidys. The investment firm attributes the recent 10% selloff over the past week, at least in part, to the new adverse event entry.
The safety issues have also triggered legal action, with Bragar Eagel & Squire (search) filing a class action lawsuit against Sarepta. The lawsuit alleges materially false and misleading statements regarding Elevidys and its revenue outlook, targeting investors who purchased or acquired Sarepta securities between June 22, 2023, and June 24, 2025.