Minerva Neurosciences, Inc: Minerva Neurosciences Announces FDA Recommendation for Type C Meeting to Discuss Evidence for Use of Roluperidone as Monotherapy for the Treatment of Negative Symptoms in Patients with Schizophrenia in Advance of Potential NDA

WALTHAM, Mass., Nov. 03, 2021 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that the U. S. Food and Drug Administration (FDA) has denied the company's request for a pre-NDA meeting for roluperidone and responded that a Type C guidance meeting would be more appropriate to discuss the evidence for use of roluperidone as monotherapy. Subject to the timing of and feedback from the FDA at a Type C guidance meeting, which the Company plans to request, the Company has not changed its previously announced projected timeline for submission of the NDA in the first half of 2022.

Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva commented, "We thank the FDA for suggesting a Type C meeting to discuss roluperidone as a monotherapy for the treatment of negative symptoms in patients with schizophrenia. There are currently no approved drugs in the U.S. for the treatment of the negative symptoms of schizophrenia. There is a large percentage of patients with schizophrenia who suffer predominantly negative symptoms."

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Forward-Looking Safe Harbor Statement

This press release contains forward-looking statements. Forward-looking statements are statements that are not historical facts, reflect management's expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include, but are not limited to, statements herein with respect to the timing and scope of clinical trials and regulatory review and results and outcomes of such clinical trials and regulatory review with roluperidone. The forward-looking statements in this press release are based on information available to us as of the date hereof, and we disclaim any obligation to update any forward-looking statements, except as required by law.

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