FDA upholds refusal to file Minerva's NDA for roluperidone for schizophrenia negative symptoms

Minerva Neurosciences, Inc.

FDA confirmed refusal-to-file letter dated Oct 14, 2022 remains in effect after Type A meeting on Nov 30, 2022.
NDA for roluperidone for treatment of negative symptoms in schizophrenia denied filing by FDA.
Company will continue to work with FDA and assess next steps for roluperidone.

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