secwatch.observer — SEC 8-K summary
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Issuer:     Minerva Neurosciences, Inc. (NERV)
CIK:        0001598646
Form:       8-K
Filed at:   2022-08-22T23:59:59+00:00
Accession:  0001193125-22-226016
Event type: other_material
Sentiment:  neutral
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Minerva submits NDA to FDA for roluperidone (64 mg) to treat negative symptoms of schizophrenia
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- NDA supported by two late-stage studies (MIN-101C03 and MIN-101C07) in patients with moderate to severe negative symptoms.
- Study MIN-101C03 met primary endpoint: statistically significant reduction in negative symptoms (p≤0.0036) at 12 weeks.
- Study MIN-101C07 marginally missed primary ITT analysis (p≤0.064) but showed significance in mITT (p≤0.044) and on key secondary PSP scale.
- Company seeks approval for 64 mg dose; no approved therapies currently exist in the US for negative symptoms of schizophrenia.
- Additional data provided following March 2022 Type C meeting with FDA to address impact on antipsychotics, comparability of patients, and statistical evidence.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1598646/000119312522226016/0001193125-22-226016-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1598646/000119312522226016/d364410d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-22-226016

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