---
schema_version: "secwatch.filing_event.v1"
accession: "0001171843-25-001678"
form_type: "8-K"
ticker: "FLNA"
cik: "0001069530"
company_name: "FILANA THERAPEUTICS, INC."
filed_at: "2025-03-25T23:59:59+00:00"
generated_at: "2026-05-24T05:28:06.608038+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.95
calibrated_materiality_score: 0.95
confidence: "high"
source: SEC EDGAR
---

# Cassava Sciences simufilam Phase 3 trial fails all endpoints; Alzheimer's program discontinued

## Summary
- Phase 3 REFOCUS-ALZ failed all co-primary, secondary, and biomarker endpoints.
- Simufilam showed no significant difference vs placebo on ADAS-COG12 or ADCS-ADL; p-values 0.37-0.67 and 0.16-0.23.
- Cassava will discontinue all simufilam Alzheimer's development by Q2 2025.
- Company had $128.6M cash at Dec 31, 2024; exploring TSC-related epilepsy.

## SEC filing metadata
- accession: 0001171843-25-001678
- form_type: 8-K
- ticker: FLNA
- cik: 0001069530
- company_name: FILANA THERAPEUTICS, INC.
- filed_at: 2025-03-25T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.95
- calibrated_materiality_score: 0.95
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1069530/000117184325001678/0001171843-25-001678-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1069530/000117184325001678/f8k_032525.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001171843-25-001678
- JSON: https://secwatch.observer/filing/0001171843-25-001678.json
- Plain text: https://secwatch.observer/filing/0001171843-25-001678.txt

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