Cassava Sciences Faces FDA Demand for Additional Data on Simufilam Study
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 03 2025
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Source: SeekingAlpha
FDA Request for Information: Cassava Sciences has received a request from the FDA for additional information regarding its investigational new drug application for simufilam, which is intended for treating tuberous sclerosis complex-related epilepsy.
Impact on Clinical Study Timeline: The FDA's request may delay the start of the proposed clinical study, although Cassava still aims to begin its proof-of-concept trial in the first half of 2026.
Market Reaction: Following the news, SAVA shares initially fell by 13% in premarket trading but later recovered to show a 1% increase.
Company Developments: Cassava Sciences has been active in the market, including insider stock purchases and filing a $200 million mixed securities shelf.
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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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