{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-047110","form_type":"8-K","ticker":"NERV","cik":"0001598646","company_name":"Minerva Neurosciences, Inc.","filed_at":"2024-02-27T23:59:59+00:00","discovered_at":"2026-05-14T18:03:24.757840+00:00","generated_at":"2026-06-05T11:55:57.015442+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":1.0,"calibrated_materiality_score":1.0,"confidence":"high","headline":"FDA issues Complete Response Letter for roluperidone; NDA not approved","bullets":["FDA cited single positive study insufficient; requires at least one additional positive well-controlled trial.","CRL also demands data on co-administration with antipsychotics and clinically meaningful change.","Safety database inadequate: too few subjects on 64 mg for 12+ months.","Minerva will request a meeting with FDA to discuss path forward; CEO expresses disappointment.","Roluperidone was targeting negative symptoms of schizophrenia, an unmet need."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-047110","json":"https://secwatch.observer/filing/0001193125-24-047110.json","markdown":"https://secwatch.observer/filing/0001193125-24-047110.md","text":"https://secwatch.observer/filing/0001193125-24-047110.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1598646/000119312524047110/0001193125-24-047110-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1598646/000119312524047110/d795805d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-05T11:55:57.015442+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"}