Minerva submits NDA to FDA for roluperidone (64 mg) to treat negative symptoms of schizophrenia

Minerva Neurosciences, Inc.

NDA supported by two late-stage studies (MIN-101C03 and MIN-101C07) in patients with moderate to severe negative symptoms.
Study MIN-101C03 met primary endpoint: statistically significant reduction in negative symptoms (p≤0.0036) at 12 weeks.
Study MIN-101C07 marginally missed primary ITT analysis (p≤0.064) but showed significance in mITT (p≤0.044) and on key secondary PSP scale.
Company seeks approval for 64 mg dose; no approved therapies currently exist in the US for negative symptoms of schizophrenia.
Additional data provided following March 2022 Type C meeting with FDA to address impact on antipsychotics, comparability of patients, and statistical evidence.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.