Sarepta Therapeutics, Inc. (SRPT) Accused of Misleading Shareholders
According to the complaint for alleged violations of the Securities Exchange Act of 1934 between September 6, 2017 and August 19, 2019, in September 2017, Sarepta Therapeutics, Inc. (SRPT) announced positive results from its first-in-human study for the safety, tolerability, pharmacokinetics, and efficacy of its drug golodirsen. Following these auspicious results, on February 14, 2019, Sarepta revealed that the FDA had accepted the company’s New Drug Application (“NDA”) “seeking accelerated approval for golodirsen and provided a regulatory action date of August 19, 2019,” failing to mention any possible or known risks related to golodirsen. Despite positive statements about the effects of golodirsen throughout the relevant period, on August 19, 2019, Sarepta revealed that a complete response letter from the FDA expressed concerns with (1) golodirsen’s risk of infection from its intravenous infusion ports, and (2) its renal toxicity seen in pre-clinical models. On this news, Sarepta’ stock price fell $18.24, or 15%, to close at $102.07.
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