---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-25-038313"
form_type: "8-K"
ticker: "FLNA"
cik: "0001069530"
company_name: "FILANA THERAPEUTICS, INC."
filed_at: "2025-12-18T23:59:59+00:00"
generated_at: "2026-05-16T12:42:00.148551+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA places Cassava's simufilam TSC-related epilepsy trial on full clinical hold; initiation delayed beyond H1 2026

## Summary
- FDA letter on Dec 15, 2025 places proposed simufilam TSC-related epilepsy trial on full clinical hold.
- Company must provide additional pre-clinical data and modify the protocol design to address FDA's items.
- Initiation of proof-of-concept trial no longer expected in first half of 2026; revised timing depends on FDA review.
- Cassava intends to work expeditiously to satisfy FDA's information requests but offers no new timeline.

## SEC filing metadata
- accession: 0001437749-25-038313
- form_type: 8-K
- ticker: FLNA
- cik: 0001069530
- company_name: FILANA THERAPEUTICS, INC.
- filed_at: 2025-12-18T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1069530/000143774925038313/0001437749-25-038313-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1069530/000143774925038313/sava20251218_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-038313
- JSON: https://secwatch.observer/filing/0001437749-25-038313.json
- Plain text: https://secwatch.observer/filing/0001437749-25-038313.txt

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