FDA Puts Cassava's Simufilam Epilepsy Trial On Full Clinical Hold

Core Viewpoint - Cassava Sciences Inc. is facing a full clinical hold from the FDA regarding its trial for simufilam, impacting its timeline for initiating a proof-of-concept clinical trial for TSC-related epilepsy [1][2]. Group 1: FDA Communication - The FDA has formally communicated that Cassava must provide additional information, including pre-clinical data, and modify the trial protocol design [2]. - The company confirmed the full clinical hold on its investigational new drug application for simufilam [1]. Group 2: Clinical Trial Timeline - Cassava no longer expects to initiate the proof-of-concept clinical trial for simufilam in TSC-related epilepsy in the first half of 2026, as previously planned [2]. - The updated timing for the clinical trial initiation will depend on the company's ability to provide the requested information and the satisfactory completion of the FDA's review [3]. Group 3: Financial Position - As of September 30, 2025, the company reported $106.1 million in cash and cash equivalents, which is expected to support operations into 2027 [3]. Group 4: Previous Study Results - In March, Cassava shared topline results from the Phase 3 REFOCUS-ALZ study of simufilam in mild-to-moderate Alzheimer's disease, which did not meet the prespecified co-primary, secondary, and exploratory biomarker endpoints [4]. - Following these results, the company has discontinued the development of simufilam for Alzheimer's disease [4]. Group 5: Market Reaction - Following the news, Cassava Sciences shares fell by 25.26%, trading at $2.13 at the time of publication [5].