Minerva Neurosciences announces FDA files NDA for roluperidone after appeal of refuse-to-file

Minerva Neurosciences, Inc.

FDA filed Minerva's NDA for roluperidone on April 27, 2023, to treat negative symptoms in schizophrenia.
FDA had issued a refuse-to-file letter in October 2022; appeal granted by FDA deciding official.
Issues from the April 2022 Type C meeting will be considered during NDA review.
No approved treatments exist for negative symptoms of schizophrenia; roluperidone aims to address that gap.

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