Sarepta Therapeutics, Inc. Class Action Lawsuit
- Company Name
- Sarepta Therapeutics, Inc.
- Stock Symbol
- Class Period
- September 6, 2017 to August 19, 2019
- Motion Deadline
- October 29, 2019
- Southern District of New York
On August 30, 2019, the Sarepta Therapeutics, Inc. class action lawsuit was filed charging Sarepta and certain of its officers with violations of the Securities Exchange Act of 1934. The Sarepta class action lawsuit was commenced in the United States District Court for the Southern District of New York on behalf of all persons who purchased or otherwise acquired Sarepta securities between September 6, 2017 and August 19, 2019 (the “Class Period”) and is captioned Salinger v. Sarepta Therapeutics, Inc., No. 1:19-cv-08122.
Sarepta is focused on the discovery and development of RNA-based therapeutics, gene therapy, and other genetics-based approaches for the treatment of rare diseases. Sarepta’s product pipeline includes, among other drug candidates, golodirsen for the treatment of duchenne muscular dystrophy (“DMD”). Golodirsen purportedly binds to exon 53 of dystrophin pre-mRNA, which results in exclusion or skipping of exon during mRNA processing in patients with genetic mutations.
On September 6, 2017, Sarepta announced positive muscle biopsy results from its Phase 1/2 first-in-human study conducted in Europe to assess the safety, tolerability, pharmacokinetics, and efficacy of golodirsen in 25 male subjects with confirmed deletions of the DMD gene amenable to skipping exon 53 (the “4053-101 Study”). On February 14, 2019, Sarepta announced the U.S. Food and Drug Administration (“FDA”) had accepted its New Drug Application (“NDA”) “seeking accelerated approval for golodirsen (SRP-4053) and provided a regulatory action date of August 19, 2019.” According to Sarepta, Sarepta had completed its NDA at the end of 2018 as part of a rolling submission and had requested priority review, which was granted. Additionally, the NDA included data from the 4053-101 Study.
The Sarepta class action lawsuit alleges that throughout the Class Period, defendants made materially false and misleading statements and/or failed to disclose adverse information regarding Sarepta’s business and prospects. Specifically, defendants failed to disclose that golodirsen posed significant safety risks to patients and, consequently, the NDA Sarepta had submitted for accelerated approval of golodirsen for the treatment of DMD was unlikely to receive approval from the FDA. As a result of this information being withheld from the market, Sarepta securities traded at artificially inflated prices of more than $150 per share during the Class Period.
Then on August 19, 2019, after the market closed, Sarepta announced it had received a Complete Response Letter (“CRL”) from the FDA regarding Sarepta’s NDA seeking accelerated approval of golodirsen for the treatment of DMD. Sarepta disclosed that “[t]he CRL generally cites two concerns: the risk of infections related to intravenous infusion ports and renal toxicity seen in pre-clinical models of golodirsen and observed following administration of other antisense oligonucleotides.” On this news, the price of Sarepta shares fell $18.24 per share, or more than 15%, to close at $102.07 per share on August 20, 2019.
The Private Securities Litigation Reform Act of 1995 permits any investor who purchased Sarepta securities during the Class Period to seek appointment as lead plaintiff in the Sarepta class action lawsuit. A lead plaintiff will act on behalf of all other class members in directing the Sarepta class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the Sarepta class action lawsuit. An investor’s ability to share in any potential future recovery of the Sarepta class action lawsuit is not dependent upon serving as lead plaintiff. If you wish to serve as lead plaintiff of the Sarepta class action lawsuit or have questions concerning your rights regarding the Sarepta class action lawsuit, please provide your information here or contact counsel, Brian Cochran at 800/449-4900 or 619/231-1058, or via e-mail at email@example.com. Lead plaintiff motions for the Sarepta class action lawsuit must be filed with the court no later than October 29, 2019.
Robbins Geller Rudman & Dowd LLP is one of the world’s leading law firms representing investors in securities class action litigation. With 200 lawyers in 9 offices, Robbins Geller has obtained many of the largest securities class action recoveries in history. For six consecutive years, ISS Securities Class Action Services has ranked the Firm in its annual SCAS Top 50 Report as one of the top law firms in the world in both amount recovered for shareholders and total number of class action settlements. Robbins Geller attorneys have helped shape the securities laws and have recovered tens of billions of dollars on behalf of aggrieved victims. Beyond securing financial recoveries for defrauded investors, Robbins Geller also specializes in implementing corporate governance reforms, helping to improve the financial markets for investors worldwide. Robbins Geller attorneys are consistently recognized by courts, professional organizations and the media as leading lawyers in the industry.