secwatch.observer — SEC 8-K summary
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Issuer:     Minerva Neurosciences, Inc. (NERV)
CIK:        0001598646
Form:       8-K
Filed at:   2021-11-03T23:59:59+00:00
Accession:  0001193125-21-317782
Event type: regulatory
Sentiment:  neutral
Materiality: 0.60
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA denies Minerva's pre-NDA meeting request for roluperidone, recommends Type C meeting
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- FDA denied pre-NDA meeting for roluperidone (negative symptoms of schizophrenia); recommends Type C guidance meeting instead.
- Minerva plans to request the Type C meeting; still targeting NDA submission in first half of 2022.
- No FDA-approved drugs exist in the U.S. for negative symptoms of schizophrenia.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1598646/000119312521317782/0001193125-21-317782-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1598646/000119312521317782/d193784d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-21-317782

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