Filana Therapeutics - FDA Lifts Clinical Hold On Filana's Simufilam For TSC-Related Epilepsy - FLNA News | RalliesFilana Therapeutics - FDA Lifts Clinical Hold On Filana's Simufilam For TSC-Related Epilepsy
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FLNA• FDA lifts hold on Simufilam
- Filana Therapeutics announced the FDA has lifted the clinical hold on Simufilam, enabling a Phase 2a study in TSC-related epilepsy.
- Patient screening for the Phase 2a study is expected to begin by Q1 2027.
- The Phase 2a study is planned to enroll 40 subjects at 13 U.S. sites over 16 weeks.
- Subjects will be eligible for a 48-week extension study after the double-blind phase.
