{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-21-317782","form_type":"8-K","ticker":"NERV","cik":"0001598646","company_name":"Minerva Neurosciences, Inc.","filed_at":"2021-11-03T23:59:59+00:00","discovered_at":"2026-05-14T18:04:13.217564+00:00","generated_at":"2026-06-28T14:02:29.065028+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"FDA denies Minerva's pre-NDA meeting request for roluperidone, recommends Type C meeting","bullets":["FDA denied pre-NDA meeting for roluperidone (negative symptoms of schizophrenia); recommends Type C guidance meeting instead.","Minerva plans to request the Type C meeting; still targeting NDA submission in first half of 2022.","No FDA-approved drugs exist in the U.S. for negative symptoms of schizophrenia."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-21-317782","json":"https://secwatch.observer/filing/0001193125-21-317782.json","markdown":"https://secwatch.observer/filing/0001193125-21-317782.md","text":"https://secwatch.observer/filing/0001193125-21-317782.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1598646/000119312521317782/0001193125-21-317782-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1598646/000119312521317782/d193784d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-28T14:02:29.065028+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"}