FLNA Filana Therapeutics

Filana Therapeutics updates simufilam TSC program amid FDA clinical hold

The company is actively working to address FDA’s Clinical Hold on the simufilam IND for TSC-related epilepsy, including planned submission of additional pre-clinical data and protocol design modifications. The timeline for initiation of a clinical trial will depend on the Company’s ability to provide the requested information to FDA and on satisfactory completion of FDA’s review.

Filana Therapeutics addresses FDA clinical hold on simufilam IND

The Company received a full clinical hold letter from FDA in December 2025 and is now actively addressing the agency’s requests for additional pre-clinical data and protocol modifications. A response to FDA is planned for submission as soon as practicable, with a progress update expected in the coming months.

Cassava Sciences: FDA places simufilam TSC epilepsy trial on full clinical hold

FDA issued a formal letter placing the proposed proof-of-concept trial for simufilam in TSC-related epilepsy on full clinical hold. The hold requires additional pre-clinical data and protocol modifications. Cassava no longer expects to start the trial in H1 2026.