secwatch.observer — SEC 8-K summary
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Issuer:     Minerva Neurosciences, Inc. (NERV)
CIK:        0001598646
Form:       8-K
Filed at:   2022-04-07T23:59:59+00:00
Accession:  0001193125-22-098270
Event type: other_material
Sentiment:  negative
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA says Phase 3 study for roluperidone remains negative; additional data needed
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- FDA stated the Phase 3 study is negative under the Hochberg procedure; both 32 mg and 64 mg doses must be significant.
- Excluding a site with data integrity issues gave nominal p=0.044 for 64 mg dose, but FDA still deems study negative.
- Division raised concerns about monotherapy use, patient identification, and lack of data on coadministration with antipsychotics.
- FDA suggested additional data could address concerns; Minerva may begin data collection in parallel with NDA preparations.
- Minerva still believes it has two adequate studies and targets NDA submission in summer 2022; webcast April 13.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1598646/000119312522098270/0001193125-22-098270-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1598646/000119312522098270/d323194d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-22-098270

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