Cassava Sciences shares decline due to postponement of epilepsy research
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 19 2025
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Source: SeekingAlpha
Clinical Trial Delay: Cassava Sciences' lead candidate, simufilam, faces a delay in its clinical trial for epilepsy due to concerns raised by the U.S. FDA, resulting in a ~14% drop in premarket shares.
FDA's Clinical Hold: The FDA has placed the proposed study on full clinical hold, requiring additional preclinical data before the trial can proceed, which has pushed back the expected start date beyond H1 2026.
Previous Setbacks: The company has already discontinued its Alzheimer's disease development program for simufilam following issues in a late-stage trial.
Company's Response: Cassava Sciences has stated its intention to address the FDA's concerns promptly to move forward with the trial.
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Analyst Views on SAVA
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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