---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-25-036710"
form_type: "8-K"
ticker: "FLNA"
cik: "0001069530"
company_name: "FILANA THERAPEUTICS, INC."
filed_at: "2025-12-03T23:59:59+00:00"
generated_at: "2026-05-16T15:00:30.336550+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.5
calibrated_materiality_score: 0.5
confidence: "high"
source: SEC EDGAR
---

# Cassava Sciences receives FDA request for additional info on simufilam IND for TSC-related epilepsy

## Summary
- Submitted IND for simufilam in tuberous sclerosis complex (TSC)-related epilepsy.
- FDA notified Company on Nov 26, 2025, then on Dec 2, 2025, requesting additional info to assess risks.
- Company expects formal FDA letter with details; will work collaboratively to address issues.
- Proof-of-concept study initiation still targeted for first half of 2026.

## SEC filing metadata
- accession: 0001437749-25-036710
- form_type: 8-K
- ticker: FLNA
- cik: 0001069530
- company_name: FILANA THERAPEUTICS, INC.
- filed_at: 2025-12-03T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.5
- calibrated_materiality_score: 0.5
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1069530/000143774925036710/0001437749-25-036710-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1069530/000143774925036710/sava20251201_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-036710
- JSON: https://secwatch.observer/filing/0001437749-25-036710.json
- Plain text: https://secwatch.observer/filing/0001437749-25-036710.txt

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