Filana Therapeutics, Inc.
- Market Cap (Float-Adj) (Float-adjusted market cap computed by the low-float screener — matches the screener row. May differ from the standard cap (price × all shares outstanding) reported elsewhere.)
- $42.0M
- Price
- $0.8698
- % Change (Daily % change from the live per-ticker quote feed.)
- -6.56%
- Volume
- 1.0M
About
Filana Therapeutics, Inc. is a company dedicated to pioneering new pharmaceutical products and diagnostic technologies. A key area of its research is focused on creating potential treatments for Alzheimer's disease, including the investigational compounds PTI-125 and PTI-125Dx. Established by Remi Barbier in May 1998, the firm maintains its principal office in Austin, Texas.
Quick stats
Shares outstanding48.3M
Computed float45.8M
Float / shares94.9%
Cash runway (months)125.5
Key info
SectorHealthcare
IndustryBiotechnology
CIK (Central Index Key — the unique ID the SEC assigns to every filer. Use it to look up the company's filings on EDGAR.)0001069530
Websitehttps://www.filanatx.com
AI Summary
AI-generated1/6
majorbullishregulatory
Filana Therapeutics Announces FDA Lift of Clinical Hold on Simufilam, Enabling Phase 2a Study in TSC-Related Epilepsy
The FDA has lifted the clinical hold on Filana Therapeutics' investigational new drug application for simufilam, clearing the company to proceed with a planned Phase 2a proof-of-concept study in TSC-related epilepsy.
Patient screening is expected to begin by the first quarter of 2027. The 16-week multicenter, randomized, double-blind trial will run at 13 U.S. sites with a target enrollment of 40 subjects aged 12 to 55, and completers are eligible for a 48-week extension study.
Filana used the hold period to complete trial-readiness work, including engaging a clinical research organization, identifying trial sites, and recruiting investigators, and it holds an exclusive worldwide license from Yale University for simufilam in TSC-related epilepsy.
The opportunity is sizable: TSC-related epilepsy affects approximately 45,000 people in the U.S., and more than 60% of TSC patients remain refractory to existing antiepileptic therapy.
Red flags
- release does not explain why the FDA placed the original clinical hold or how long it lasted
- simufilam remains investigational and unapproved in any jurisdiction; Phase 2a is early-stage with only 40 planned subjects
- clinical endpoints (seizure frequency, sleep outcomes) are exploratory; no guarantee data support further development