{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-22-226016","form_type":"8-K","ticker":"NERV","cik":"0001598646","company_name":"Minerva Neurosciences, Inc.","filed_at":"2022-08-22T23:59:59+00:00","discovered_at":"2026-05-14T18:03:56.313819+00:00","generated_at":"2026-06-23T22:17:16.388760+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Minerva submits NDA to FDA for roluperidone (64 mg) to treat negative symptoms of schizophrenia","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-22-226016","json":"https://secwatch.observer/filing/0001193125-22-226016.json","markdown":"https://secwatch.observer/filing/0001193125-22-226016.md","text":"https://secwatch.observer/filing/0001193125-22-226016.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1598646/000119312522226016/0001193125-22-226016-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1598646/000119312522226016/d364410d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-23T22:17:16.388760+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}