Block & Leviton LLP has filed a class action lawsuit on behalf of shareholders against Minerva Neurosciences, Inc. (NASDAQ: NERV) and certain of its executives for securities fraud.
On December 1, 2020, Minerva 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’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.” The market was stunned by this development, and as a result, Minerva shares fell approximately 26% in one day.
This most recent development follows Minerva’s May 29, 2020 announcement of 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. Minerva shares fell approximately 72.5% on that development.