---
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"
generated_at: "2026-05-17T00:31:36.583944+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# CervoMed gets FDA alignment on Phase 3 trial design for neflamapimod in DLB

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-032869
- JSON: https://secwatch.observer/filing/0001437749-25-032869.json
- Plain text: https://secwatch.observer/filing/0001437749-25-032869.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.