Cassava Sciences receives FDA request for additional info on simufilam IND for TSC-related epilepsy

FILANA THERAPEUTICS, INC.

Submitted IND for simufilam in tuberous sclerosis complex (TSC)-related epilepsy.
FDA notified Company on Nov 26, 2025, then on Dec 2, 2025, requesting additional info to assess risks.
Company expects formal FDA letter with details; will work collaboratively to address issues.
Proof-of-concept study initiation still targeted for first half of 2026.

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