NEW YORK, Sept. 12, 2019 (GLOBE NEWSWIRE) — Pomerantz LLP announces that a class action lawsuit has been filed against Sarepta Therapeutics, Inc. (“Sarepta” or the “Company”) (NASDAQ: SRPT) and certain of its officers. The class action, filed in United States District Court, for the Southern District of New York, and indexed under 19-cv-08122, is on behalf of a class consisting of all persons and entities other than Defendants who purchased or otherwise, acquired publicly traded Sarepta securities between September 6, 2017 and August 19, 2019, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.
If you are a shareholder who purchased Sarepta securities during the class period, you have until October 29, 2019, to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at firstname.lastname@example.org or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 9980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
Sarepta purports to focus on the discovery and development of ribonucleic acid (“RNA”)-based therapeutics, gene therapy, and other genetic medicine approaches for the treatment of rare diseases. Sarepta’s products 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, pre-market, Sarepta announced positive muscle biopsy results from its 4053-101 study, a Phase 1/2 first-in-human study conducted in Europe to assess the safety, tolerability, pharmacokinetics, and efficacy of golodirsen in twenty-five male subjects with confirmed deletions of the DMD gene amenable to skipping exon 53 (the “4053-101 Study”).
According to Sarepta, the 4053-101 Study comprised two parts. In Part 1, twelve patients were randomized to receive a dose titration of golodirsen (eight patients) or placebo (four patients). At the end of Part 1 (dose titration), all twelve patients continued on golodirsen and an additional thirteen patients started golodirsen (Part 2). In Part 2, all twenty-five patients were treated for an additional forty-eight weeks at the time of muscle biopsy. The analysis included biopsies of the bicep muscle at baseline and on-treatment at the Part 2 Week 48 time point.
On February 14, 2019, Sarepta announced that the U.S. Food and Drug Administration’s (“FDA”) Division of Neurology (the “FDA Neurology Division”) had accepted the Company’s New Drug Application (“NDA”) “seeking accelerated approval for golodirsen (SRP-4053) and provided a regulatory action date of August 19, 2019.” According to Sarepta, the Company completed its NDA at the end of 2018 as part of a rolling submission and requested priority review, which was granted. Additionally, the NDA included data from the 4053-101 Study.
The complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding Sarepta’s business, operational and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) golodirsen posed significant safety risks to patients; (ii) consequently, the NDA package for golodirsen’s accelerated approval was unlikely to receive FDA approval; and (iii) as a result, Sarepta’s public statements were materially false and misleading at all relevant times.
On August 19, 2019, post-market, Sarepta announced receipt of a Complete Response Letter (“CRL”) from the FDA regarding the Company’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, Sarepta’s stock price fell $18.24 per share, or 15.16%, to close at $102.07 per share on August 20, 2019.
The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com
Robert S. Willoughby