Minerva Neurosciences Inc Common Stock (NASDAQ: NERV)
According to the Complaint, Minerva Neurosciences, Inc. purports to be a clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of product candidates to treat patients suffering from central nervous diseases. The Company’s lead product candidate is roluperidone, in development for the treatment of negative symptoms in patients with schizophrenia.
The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business. Specifically, the Complaint alleges Defendants made false and/or misleading statements and/or failed to disclose that: (i) the truth about the feedback received from the FDA concerning the “end-of-Phase 2” meeting; (ii) the Phase 2b study did not use the commercial formulation of roluperidone and was conducted solely outside of the United States; (iii) 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; (iv) 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; (v) 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 (vi) as a result, the Company’s public statements were materially false and misleading at all relevant times.