{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-25-032869","form_type":"8-K","ticker":"CRVO","cik":"0001053691","company_name":"CervoMed Inc.","filed_at":"2025-11-04T23:59:59+00:00","discovered_at":"2026-05-14T18:02:38.674497+00:00","generated_at":"2026-05-17T00:31:36.583944+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"CervoMed gets FDA alignment on Phase 3 trial design for neflamapimod in DLB","bullets":["FDA aligned on primary endpoint (CDR-SB), patient enrichment strategy, and trial design for ~300 DLB patients.","Enrollment to exclude Alzheimer’s co-pathology via brain imaging, CSF, and plasma ptau181 ≥ 21.0 pg/mL cutoff.","Phase 3 trial planned to start in H2 2026; 32-week double-blind period followed by 48-week open-label extension.","No approved therapies for DLB in US or EU; neflamapimod targets cognitive and functional decline.","Company expects additional global regulatory feedback in coming months; detailed design early 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-25-032869","json":"https://secwatch.observer/filing/0001437749-25-032869.json","markdown":"https://secwatch.observer/filing/0001437749-25-032869.md","text":"https://secwatch.observer/filing/0001437749-25-032869.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1053691/000143774925032869/0001437749-25-032869-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1053691/000143774925032869/crvo20251104_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T00:31:36.583944+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"}