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FDA lifts clinical hold on simufilam IND; Phase 2a in TSC epilepsy

Filana Therapeutics said the FDA lifted the clinical hold on its IND for simufilam, enabling a planned Phase 2a study in TSC-related epilepsy, with screening expected to begin by Q1 2027.

FLNA

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12:02:01 PM UTC
SquawkNews
FLNA - Filana Therapeutics Announces FDA Lift of Clinical Hold on Simufilam, Enabling Phase 2a Study in TSC-Related Epilepsy
12:04:35 PM UTC
SquawkNews
Filana Therapeutics said the FDA lifted the clinical hold on its IND for simufilam, enabling a planned Phase 2a study in TSC-related epilepsy. Screening is expected to begin by Q1 2027.Material DetailsContext by AI AnalystThis is an early-stage regulatory green light in Filana’s shift to TSC-relate…