secwatch.observer — SEC 8-K summary
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Issuer:     Minerva Neurosciences, Inc. (NERV)
CIK:        0001598646
Form:       8-K
Filed at:   2022-12-28T23:59:59+00:00
Accession:  0001193125-22-313129
Event type: regulatory
Sentiment:  negative
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA upholds refusal to file Minerva's NDA for roluperidone for schizophrenia negative symptoms
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- FDA confirmed refusal-to-file letter dated Oct 14, 2022 remains in effect after Type A meeting on Nov 30, 2022.
- NDA for roluperidone for treatment of negative symptoms in schizophrenia denied filing by FDA.
- Company will continue to work with FDA and assess next steps for roluperidone.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1598646/000119312522313129/0001193125-22-313129-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1598646/000119312522313129/d441264d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-22-313129

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