FDA Lifts Clinical Hold on FILANA's Simufilam in TSC Epilepsy

Filana Therapeutics (FLNA) said the U.S. Food and Drug Administration has lifted the clinical hold on its investigational new drug application for simufilam, clearing the way for a planned Phase 2a proof-of-concept study in patients aged 12 to 55 with tuberous sclerosis complex-related epilepsy. Patient screening is expected to begin by the first quarter of 2027. Simufilam is the company's only clinical asset, making the decision central to its development plan.