Minerva's roluperidone bioequivalence study meets all PK objectives; pre-NDA meeting planned

Minerva Neurosciences, Inc.

Study showed bioequivalence in AUC_inf between Phase 2b, Phase 3, and planned commercial formulations.
C_max reduced substantially in reformulated Phase 3 and commercial tablets vs Phase 2b formulation.
Commercial formulation bioequivalent with or without food; 45 of 48 subjects completed study.
Company to request pre-NDA meeting with FDA for roluperidone for negative symptoms of schizophrenia.
No approved treatments in US for negative symptoms of schizophrenia; roluperidone is potential first-in-class.

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