December 8, 2020 - An investor in shares of Minerva Neurosciences, Inc. (NASDAQ: NERV) filed a lawsuit in the U.S. District Court for the District of Massachusetts over alleged violations of Federal Securities Laws by Minerva Neurosciences, Inc. in connection with certain allegedly false and misleading statements made between May 15, 2017 and November 30, 2020.

Waltham, MA based Minerva Neurosciences, Inc., a clinical-stage biopharmaceutical company, focuses on the development and commercialization of a portfolio of product candidates for the treatment of central nervous system diseases.

On May 29, 202, Minerva Neurosciences, Inc. announced the results of its Phase III clinical trial for the use of roluperidone to treat negative symptoms in schizophrenia. The Phase III study failed to show statistically significant differences from placebo on both the primary and key secondary endpoints.
Shares of Minerva Neurosciences, Inc. (NASDAQ: NERV) declined from $14.70 per share on May 26, 2020, to as low as $1.81 per share on May 29, 2020.

On December 1, 2020, Minerva Neurosciences, Inc. announced the results of its meeting with the U.S. Food and Drug Administration concerning Minerva’s attempt to submit a New Drug Application for roluperidone, to treat negative symptoms in schizophrenia. The FDA advised that an NDA submission based on Minerva Neurosciences, Inc’s current data from two studies “would be highly unlikely to be filed” and that doing so would present “substantial review issues due to the lack of two adequate and well-controlled trials to support efficacy claims.”
Shares of Minerva Neurosciences, Inc. (NASDAQ: NERV) declined from $4.115 per share on November 27, 2020, to as low as $2.51 per share on December 4, 2020.

According to the complaint the plaintiff alleges on behalf of purchasers of Minerva Neurosciences, Inc. (NASDAQ: NERV) common shares between May 15, 2017 and November 30, 2020, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that between May 15, 2017 and November 30, 2020, Minerva Neurosciences, Inc. made materially false and/or misleading statements and/or failed to disclose that the truth about the feedback received from the FDA concerning the end-of-Phase 2 meeting, that the Phase 2b study did not use the commercial formulation of roluperidone and was conducted solely outside of the United States, that the failure of the Phase 3 study to meet its primary and key secondary endpoints rendered that study incapable of supporting substantial evidence of effectiveness, that the Company's plan to use the combination of the Phase 2b and Phase 3 studies would be highly unlikely to support the submission of an NDA, that reliance on these two trials in the submission of an NDA would lead to substantial review issues because the trials were inadequate and not well-controlled, and that as a result, the Company's public statements were materially false and misleading at all relevant times.