---
schema_version: "secwatch.filing_event.v1"
accession: "0001171843-26-006161"
form_type: "8-K"
ticker: "FLNA"
cik: "0001069530"
company_name: "FILANA THERAPEUTICS, INC."
filed_at: "2026-09-22T12:00:40+00:00"
generated_at: "2026-09-22T12:05:38.522350+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA lifts clinical hold on Filana's simufilam, enabling Phase 2a trial for TSC-related epilepsy

## Summary
- FDA lifted full clinical hold on Filana's IND for simufilam on Sept 22, 2026, enabling Phase 2a trial in TSC-related epilepsy.
- Phase 2a trial: 16-week, randomized, double-blind, two doses, 13 U.S. sites, target 40 subjects aged 12-55; screening expected Q1 2027.
- Company completed trial-readiness during hold: engaged leading CRO, identified sites, recruiting investigators, drug supply in place.
- TSC Alliance CEO Kari Luther Rosbeck praised work; simufilam reduced seizure frequency in two preclinical mouse models.

## SEC filing metadata
- accession: 0001171843-26-006161
- form_type: 8-K
- ticker: FLNA
- cik: 0001069530
- company_name: FILANA THERAPEUTICS, INC.
- filed_at: 2026-09-22T12:00:40+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1069530/000117184326006161/0001171843-26-006161-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1069530/000117184326006161/f8k_092226.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001171843-26-006161
- JSON: https://secwatch.observer/filing/0001171843-26-006161.json
- Plain text: https://secwatch.observer/filing/0001171843-26-006161.txt

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