{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-26-031389","form_type":"8-K","ticker":"CRVO","cik":"0001053691","company_name":"CervoMed Inc.","filed_at":"2026-09-28T21:07:31+00:00","discovered_at":"2026-09-28T21:08:32.370195+00:00","generated_at":"2026-10-12T13:38:01.347560+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"CervoMed says new 50 mg neflamapimod tablet plus FDA removal of exposure limit enables 100 mg BID dosing","bullets":["New 50 mg tablet uses most stable crystalline form, addressing manufacturing variability of the 40 mg capsule in Phase 2b RewinD-LB; Phase 1 food-effect/drug-exposure study met primary objectives.","50 mg tablet vs prior 40 mg capsule: similar overall plasma exposure, ~20% lower Cmax and ~20% higher 12-hour trough, supporting twice-daily dosing.","FDA removed neflamapimod's prior plasma exposure limit after a 39-week dog tox study set a NOAEL 3-fold higher than prior dog studies and >30x the active clinical exposure range.","Plans 100 mg BID regimen; PK modeling projects ~33% higher trough levels than the 40 mg TID dose used in Phase 2a and the Phase 2b extension in DLB, cutting dosing to twice daily.","CEO John J. Alam says the new tablet addresses the formulation issue from RewinD-LB and expects substantially higher trough concentrations, reducing clinical execution and CMC risk."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-26-031389","json":"https://secwatch.observer/filing/0001437749-26-031389.json","markdown":"https://secwatch.observer/filing/0001437749-26-031389.md","text":"https://secwatch.observer/filing/0001437749-26-031389.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1053691/000143774926031389/0001437749-26-031389-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1053691/000143774926031389/crvo20260928_8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T13:38:01.347560+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"}