{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-22-263403","form_type":"8-K","ticker":"NERV","cik":"0001598646","company_name":"Minerva Neurosciences, Inc.","filed_at":"2022-10-17T23:59:59+00:00","discovered_at":"2026-05-14T18:03:51.355168+00:00","generated_at":"2026-06-23T03:20:01.463471+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":"Minerva Neurosciences receives FDA refusal to file for roluperidone NDA in schizophrenia negative symptoms","bullets":["FDA issued Refusal to File letter for NDA of roluperidone for negative symptoms of schizophrenia.","No approved therapies exist in US for negative symptoms of schizophrenia; company disappointed.","Company intends to request a Type A meeting to discuss the refusal to file letter.","Roluperidone is a clinical-stage therapy; NDA submission not accepted by FDA."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-22-263403","json":"https://secwatch.observer/filing/0001193125-22-263403.json","markdown":"https://secwatch.observer/filing/0001193125-22-263403.md","text":"https://secwatch.observer/filing/0001193125-22-263403.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1598646/000119312522263403/0001193125-22-263403-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1598646/000119312522263403/d370453d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-23T03:20:01.463471+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"}