Recent Updates — FLNA

On September 22, 2026, Filana Therapeutics announced that the U.S. Food and Drug Administration lifted the clinical hold on its investigational new drug application for simufilam. This regulatory clearance enables the company to initiate a planned Phase 2a proof-of-concept study in patients with tuberous sclerosis complex-related epilepsy. The trial is designed as a 16-week, multicenter, randomized, double-blind study evaluating two doses of simufilam at 13 U.S. sites, targeting an enrollment of 40 subjects aged 12 to 55. Patient screening is expected to begin in the first quarter of 2027. Filana Therapeutics operates as a biotechnology company focused on developing novel therapies for central nervous system disorders.

Filana Therapeutics received notice from Nasdaq on September 17, 2026, that its common stock failed to maintain the $1.00 minimum bid price requirement for thirty consecutive business days. The company has until March 16, 2027, to regain compliance by maintaining a closing price of at least $1.00 for ten consecutive trading days. Failure to comply may result in delisting from the Nasdaq Capital Market. Filana Therapeutics operates as a clinical-stage biopharmaceutical company focused on developing therapies for rare diseases.

On June 11, 2026, stockholders approved Amendment No. 2 to the 2018 Omnibus Incentive Plan, increasing authorized shares from 5,000,000 to 9,000,000 and extending the plan term to January 31, 2030. The amendment prohibits the repricing, replacing, or cash-out of stock options or SARs without stockholder approval and reduces maximum annual compensation limits for non-employee directors and individual equity awards. Other annual meeting results included the election of directors Richard J. Barry, Pierre Gravier, and Claude Nicaise, and the ratification of Ernst & Young LLP as the independent auditor for fiscal year 2026. Filana Therapeutics, Inc. is a biotechnology company that develops therapeutic treatments.