FDA places Cassava's simufilam TSC-related epilepsy trial on full clinical hold; initiation delayed beyond H1 2026

FILANA THERAPEUTICS, INC.

FDA letter on Dec 15, 2025 places proposed simufilam TSC-related epilepsy trial on full clinical hold.
Company must provide additional pre-clinical data and modify the protocol design to address FDA's items.
Initiation of proof-of-concept trial no longer expected in first half of 2026; revised timing depends on FDA review.
Cassava intends to work expeditiously to satisfy FDA's information requests but offers no new timeline.

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