| COMPANY |
Sarepta Therapeutics, Inc. |
| COURT |
United States District Court for the Southern District of New York |
| CASE NUMBER |
1:25-cv-5317 |
| JUDGE |
The Hon. Paul A. Engelmayer |
| CLASS PERIOD |
June 22, 2023 through June 24, 2025 |
| SECURITY TYPE |
Securities |
LEAD PLAINTIFF DEADLINE IS AUGUST 25, 2025.
If you have suffered losses and would like to discuss your rights, please fill out this form or you may contact Jonathan Naji, Esq. at (484) 270-1453 or via e-mail at info@ktmc.com.
Case Background:
A class action lawsuit was filed on behalf of those who purchased or otherwise acquired Sarepta Therapeutics, Inc. (“Sarepta”) (NASDAQ: SRPT) securities between June 22, 2023, and June 24, 2025, inclusive (the “Class Period”).
The Class Period begins on June 22, 2023, when Sarepta issued a press release, premarket trading, announcing the upcoming start of a clinical trial for ELEVIDYS, the company’s gene therapy treatment. In the press release, Sarepta touted the purported benefits experienced with ELEVIDYS, including that “Our confirmatory trial, EMBARK, should read out in the fourth quarter of this year. If EMBARK confirms the benefits seen in our prior trials, Sarepta will move rapidly to submit a BLA supplement to expand the approved label as broadly as good science permits.”
On March 18, 2025, Sarepta issued a press release revealing that a 16-year-old boy had passed away from acute liver failure following treatment with Sarepta’s gene therapy, ELEVIDYS. On this news, Sarepta’s stock price fell $27.81 per share, or 27.44%, to close at $73.54 per share on March 18, 2025.
Then, on April 4, 2025, Sarepta disclosed that European Union member country authorities had requested that the independent data monitoring committee meet to review the death announced on March 18, 2025. Sarepta simultaneously halted recruitment and dosing in some of the ELEVIDYS clinical studies. On this news, Sarepta’s stock price fell $4.18 per share, or 7.13%, to close at $54.43 per share on April 4, 2025.
Thereafter, on June 15, 2025, Sarepta issued a press release and revealed a second reported case of acute liver failure resulting in the death of a 15-year-old boy being treated with ELEVIDYS. In response, Sarepta paused dosing in an associated clinical trial evaluating ELEVIDYS, temporarily suspended shipments of ELEVIDYS for non-ambulatory patients, and is weighing enhanced immunosuppression protocols. Following this news, Sarepta’s stock price fell more than 47%, from a close of $36.18 on June 13, 2025, to close at $20.94 on June 16, 2025.
Finally, on June 24, 2025, the FDA issued a Safety Communication announcing 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. On this news, Sarepta’s stock price fell $1.52 per share, or 8.01%, to close at $17.46 per share on June 25, 2025.
The complaint alleges that, throughout the Class Period, Defendants made false and/or misleading statements and/or failed to disclose that: (1) Sarepta’s gene therapy treatment, ELEVIDYS, posed significant safety risks to patients; (2) ELEVIDYS trial regimes and protocols failed to detect severe side effects; (3) the severity of adverse events from ELEVIDYS treatment would cause Sarepta to halt recruitment and dosing in ELEVIDYS trials, attract regulatory scrutiny, and create greater risk around the therapy’s present and expanded approvals; and (4) as a result of the foregoing, Defendants materially misled with, and/or lacked a reasonable basis for, their positive statements.
What is a Lead Plaintiff?
A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member’s claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Filling out the online form above or communicating with any counsel is not necessary to participate or share in any recovery achieved in this case. Any member of the purported class may move the court to serve as a lead plaintiff through counsel of his/her choice, or may choose to do nothing and remain an inactive class member.