Minerva Neurosciences, Inc.
Lead Plaintiff Deadline: 02/08/2021
SUMMARY OF CASE:
A securities class action has been filed against Minerva Neurosciences, Inc. (NERV) on behalf of shareholders who purchased NERV shares between May 15, 2017 through November 30, 2020. This case has been filed in the USDC – MA.
The Complaint alleges that 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.