April 22, 2020 - The case was voluntarily dismissed.

August 30, 2019 - An investor in shares of Sarepta Therapeutics, Inc. (NASDAQ: SRPT) filed a lawsuit in the U.S. District Court for the Southern District of New York over alleged violations of Federal Securities Laws by Sarepta Therapeutics, Inc. in connection with certain allegedly false and misleading statements made between September 6, 2017 and August 19, 2019.

Cambridge, MA based Sarepta Therapeutics, Inc. focuses on the discovery and development of RNA-based therapeutics, gene therapy, and other genetic medicine approaches for the treatment of rare diseases.

On August 19, 2019, Sarepta Therapeutics, Inc. announced receipt of a Complete Response Letter (“CRL”) from the U.S. Food & Drug Administration regarding the Company’s New Drug Application seeking accelerated approval of golodirsen injection for the treatment of Duchenne muscular dystrophy. 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.” Shares of Sarepta Therapeutics, Inc. (NASDAQ: SRPT) declined to as low as $90.24 per share on August 22, 2019.

According to the complaint the plaintiff alleges on behalf of purchasers of Sarepta Therapeutics, Inc. (NASDAQ: SRPT) common shares between September 6, 2017 and August 19, 2019, that the defendants violated Federal Securities Laws.

More specifically, the plaintiff claims that between September 6, 2017 and August 19, 2019, the Defendants made false and/or misleading statements and/or failed to disclose that golodirsen posed significant safety risks to patients, that consequently, the NDA package for golodirsen’s accelerated approval was unlikely to receive FDA approval, and that as a result, Sarepta’s public statements were materially false and misleading at all relevant times.