A class action lawsuit was filed against Sarepta Therapeutics (SRPT) by Levi & Korsinsky on June 26, 2025. The plaintiffs (shareholders) alleged that they bought SRPT stock at artificially inflated prices between June 22, 2023, and June 24, 2025 (Class Period) and are now seeking compensation for their financial losses. Investors who bought Sarepta stock during that period can click here to learn about joining the lawsuit.
Elevate Your Investing Strategy:
- Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
Sarepta Therapeutics is a biotechnology company focused on developing precision genetic medicines for the treatment of Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs). The company has about 40 programs in various stages of development.
The U.S. Food and Drug Administration (FDA) has approved Sarepta’s Elevidys, a prescription gene therapy intended for a limited category of people with Duchenne. DMD is an incurable, inherited condition that causes progressive muscle weakness. Experts say it is more prevalent among boys and mainly affects the muscles that facilitate movement and breathing. However, it can also affect the way the heart functions.
Sarepta’s claims about Elevidys, its safety, efficacy, and related protocols are at the heart of the current complaint.
Sarepta Therapeutics’ Misleading Claims
According to the lawsuit, Sarepta and three of its senior officers (the Defendants) repeatedly made false and misleading public statements throughout the Class Period. In particular, they are accused of omitting truthful information about Elevidys’ safety, and the efficacy of Elevidys’ trial “regimens and protocols” in detecting severe side effects, from SEC filings and related material.
During the Class Period, the CEO stated that the Elevidys EMBARK trial confirmed the benefits observed in prior trials. Accordingly, Sarepta would move rapidly to submit a Biologics License Application (BLA) supplement to expand the approved label “as broadly as sound science permits.”
Moreover, in a press release dated November 1, 2023, the CEO noted that the commercial launch of Elevidys had gotten off to a good start, with net product revenue reaching $69.1 million. The company’s total net product revenue had increased by 49% year-over-year to $309.3 million, while adjusted earnings had grown to $38 million, marking a major milestone for Sarepta.
Additionally, during an investor call on the same day, the CEO praised the drug, stating, “Elevidys stabilizes muscles, slows or entirely arrests decline, works across all age groups, and has a laudable safety profile not shared by other programs for Duchenne.”
Finally, in a press release dated May 1, 2024, the CEO noted that, since Elevidys’ approval in June of the previous year, the drug has generated cumulative sales exceeding $334 million, outperforming the combined sales of all other gene therapies approved in recent years.
However, subsequent events (detailed below) reveal that the defendants failed to inform investors about Elevidys’ safety and risk profile, and that the trial regimes and protocols had failed to detect severe side effects of the drug. There was also a possibility of halting recruitment and dosing in Elevidys trials, facing regulatory scrutiny, and creating greater risk around the therapy’s current and expanded approvals.
Plaintiffs’ Arguments
The plaintiffs maintain that the defendants deceived investors by lying and withholding critical information about the business practices, compliance, and outlook during the Class Period. Importantly, the defendants are accused of misleading investors about the true side effects of Elevidys, including the potential for patient death.
The information became clear in a series of partial disclosures. The final truth emerged on June 24, 2025, when the U.S. FDA issued a Safety Communication announcing that it had “received reports of two deaths and was investigating the risk of acute liver failure with serious outcomes following treatment with Elevidys.” The communication noted that the FDA was evaluating the need for further regulatory action.
To conclude, the defendants failed to inform investors about the drug’s potential side effects and related regulatory challenges, including the halting of sales and clinical trials. Due to these issues, SRPT stock has lost over 85% so far this year.
