Phase 3 roluperidone results published; primary endpoint missed significance in ITT

Minerva Neurosciences, Inc.

Trial published in Schizophrenia Bulletin for roluperidone to treat negative symptoms in schizophrenia.
Primary endpoint NSFS missed statistical significance in ITT (p≤0.064) but hit in m-ITT (p≤0.044).
Secondary endpoint PSP total score statistically significant for 64 mg vs placebo (ITT p≤0.021).
FDA denied pre-NDA meeting in Nov 2021; Type C meeting scheduled; NDA submission planned H1 2022.

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