secwatch.observer — SEC 8-K summary
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Issuer:     Minerva Neurosciences, Inc. (NERV)
CIK:        0001598646
Form:       8-K
Filed at:   2021-12-08T23:59:59+00:00
Accession:  0001193125-21-351399
Event type: other_material
Sentiment:  neutral
Materiality: 0.70
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Roluperidone phase 3 trial: primary endpoint missed in ITT (p=0.064) but significant in mITT; PSP improved
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- NSFS (primary) for roluperidone 64mg vs placebo: p≤0.064 (ITT), p≤0.044 (mITT).
- PSP total score (key secondary) significantly improved for 64mg vs placebo: p≤0.021 (ITT), p≤0.017 (mITT).
- Relapse rate during open-label extension: 6% (64mg) and 9% (32mg) over one year.
- Trial enrolled 513 schizophrenia patients with moderate to severe negative symptoms; monotherapy design.
- Results presented at ACNP meeting December 2021.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1598646/000119312521351399/0001193125-21-351399-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1598646/000119312521351399/d74277d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-21-351399

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