secwatch.observer — SEC 8-K summary
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Issuer:     Minerva Neurosciences, Inc. (NERV)
CIK:        0001598646
Form:       8-K
Filed at:   2022-02-28T23:59:59+00:00
Accession:  0001193125-22-056251
Event type: other_material
Sentiment:  neutral
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1598646/000119312522056251/0001193125-22-056251-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1598646/000119312522056251/d321129d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-22-056251

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer