{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-21-287430","form_type":"8-K","ticker":"NERV","cik":"0001598646","company_name":"Minerva Neurosciences, Inc.","filed_at":"2021-09-30T23:59:59+00:00","discovered_at":"2026-05-14T18:04:18.744920+00:00","generated_at":"2026-06-29T00:23:52.068258+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Minerva's roluperidone bioequivalence study meets all PK objectives; pre-NDA meeting planned","bullets":["Study showed bioequivalence in AUC_inf between Phase 2b, Phase 3, and planned commercial formulations.","C_max reduced substantially in reformulated Phase 3 and commercial tablets vs Phase 2b formulation.","Commercial formulation bioequivalent with or without food; 45 of 48 subjects completed study.","Company to request pre-NDA meeting with FDA for roluperidone for negative symptoms of schizophrenia.","No approved treatments in US for negative symptoms of schizophrenia; roluperidone is potential first-in-class."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-21-287430","json":"https://secwatch.observer/filing/0001193125-21-287430.json","markdown":"https://secwatch.observer/filing/0001193125-21-287430.md","text":"https://secwatch.observer/filing/0001193125-21-287430.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1598646/000119312521287430/0001193125-21-287430-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1598646/000119312521287430/d218690d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-29T00:23:52.068258+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"}