FDA Lifts Clinical Hold on Filana's Simufilam for TSC-Related Epilepsy; FLNA Falls Pre-Market

Filana Therapeutics, Inc. (FLNA) said on September 23, 2026, that the U.S. Food and Drug Administration lifted the clinical hold on its Investigational New Drug application for Simufilam, clearing the company to resume clinical development of the filamin A-targeted therapy for epilepsy associated with tuberous sclerosis complex (TSC). The FDA action removes a regulatory restriction that had paused the program, allowing Filana to proceed with trials in the TSC-related epilepsy indication. Despite the clearance, FLNA shares traded lower in pre-market trading, with investors apparently focused on the path and timing of the therapy's clinical advancement. Financial terms of the regulatory development were not disclosed.