FDA Places Full Clinical Hold on Cassava's Simufilam Epilepsy Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 19 2025
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Source: Benzinga
FDA Clinical Hold: Cassava Sciences Inc. received a formal letter from the FDA placing a full clinical hold on its trial for simufilam, requiring additional pre-clinical data and protocol modifications before proceeding.
Delayed Clinical Trial: The company no longer anticipates starting a proof-of-concept clinical trial for simufilam in TSC-related epilepsy in the first half of 2026, with timing now dependent on FDA review outcomes.
Discontinuation of Alzheimer's Development: Cassava has halted the development of simufilam for Alzheimer's disease after the Phase 3 REFOCUS-ALZ study failed to meet key endpoints.
Stock Price Impact: Following these developments, Cassava Sciences' shares fell by 25.26%, trading at $2.13 at the time of publication.
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About SAVA
Cassava Sciences, Inc. is a clinical-stage biopharmaceutical company focused on developing novel, investigational treatments for central nervous system disorders, including Alzheimer’s disease and tuberous sclerosis complex (TSC)-related seizures. The Company's science is based on stabilizing, but not removing, a critical protein in the brain for patients with disorders such as Alzheimer’s disease or TSC. It has two biopharmaceutical assets under development: Simufilam and SavaDx. Simufilam, its lead therapeutic product candidate, is an oral treatment for Alzheimer’s disease and TSC-related epilepsy. Simufilam targets an altered form of a protein called filamin A (FLNA) in the brain of patients with disorders such as Alzheimer’s disease or TSC. SavaDx, its lead investigational diagnostic product candidate, early-stage program focused on detecting the presence of Alzheimer’s disease from a small sample of blood.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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