{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-22-313129","form_type":"8-K","ticker":"NERV","cik":"0001598646","company_name":"Minerva Neurosciences, Inc.","filed_at":"2022-12-28T23:59:59+00:00","discovered_at":"2026-05-14T18:03:51.355741+00:00","generated_at":"2026-06-20T22:27:20.440103+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA upholds refusal to file Minerva's NDA for roluperidone for schizophrenia negative symptoms","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-22-313129","json":"https://secwatch.observer/filing/0001193125-22-313129.json","markdown":"https://secwatch.observer/filing/0001193125-22-313129.md","text":"https://secwatch.observer/filing/0001193125-22-313129.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1598646/000119312522313129/0001193125-22-313129-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1598646/000119312522313129/d441264d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-20T22:27:20.440103+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"}