Filana shares jumps 30% after FDA clears study

• Filana Therapeutics (NASDAQ:FLNA) shares rose after the FDA lifted a clinical hold on its experimental epilepsy drug simufilam.
• The stock increased 30% to $0.96 in premarket trading following the regulatory update.
• Filana stated that the FDA decision allows the company to begin a Phase 2 study evaluating simufilam in patients with epilepsy linked to tuberous sclerosis complex.

Filana Therapeutics (NASDAQ:FLNA) shares rose after the U.S. Food and Drug Administration lifted a clinical hold on its experimental drug simufilam for epilepsy linked to tuberous sclerosis complex.

The shares increased 30% to $0.96 in premarket trading after Filana announced that the FDA decision allows its mid-stage clinical study to proceed.

The planned Phase 2 study will evaluate two simufilam doses in 40 patients aged 12 to 55 across 13 U.S. clinical sites, with patient screening expected to begin by the first quarter of 2027.

Following the announcement, Filana Therapeutics share price was up 30% at $0.96 in premarket trading.

Tuberous sclerosis complex is a rare genetic disorder that can cause tumors in multiple organs and seizures that may be difficult to control.

Simufilam is designed to modify filamin A, a protein involved in maintaining cell structure and regulating cellular signals, and Filana said the drug reduced seizure activity in two mouse studies.