Sarepta Therapeutics, Inc.
- 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
The complaint charges Sarepta and certain of its officers with violations of the Securities Exchange Act of 1934. 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 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, the Company 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 complaint 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 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, 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.