Filana Therapeutics, Inc. FLNA
Filana Therapeutics, Inc. (Nasdaq: FLNA) is a CNS/neurology/psychiatry drug developer. Its lead program, simufilam, is in Phase 2 for TSC-related epilepsy. Its next catalyst on record is simufilam (TSC-related epilepsy): Phase 2a patient screening initiation (Q1 2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: simufilam (TSC-related epilepsy) — Phase 2a patient screening initiation (Q1 2027). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| simufilam | TSC-related epilepsy | small molecule | Phase 2 |
Recent results and decisions
- hold lifted FDA lifted the clinical hold on Filana's IND application for simufilam in TSC-related epilepsy in September 2026.
In September 2026, the FDA lifted the clinical hold on Filana's investigational new drug (IND) application for simufilam in Tuberous Sclerosis Complex (TSC)-related epilepsy.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 CNS/neurology/psychiatry companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.