Cassava Sciences Inc. is facing a regulatory setback after the U.S. Food and Drug Administration (FDA) placed a full clinical hold on its proposed proof-of-concept clinical trial for simufilam in tuberous sclerosis complex (TSC)-related epilepsy. The FDA requires Cassava to provide additional pre-clinical data and modify the trial protocol before the hold can be lifted. As a result, the company no longer expects to begin the clinical trial in the first half of 2026, and the revised timeline will depend on how quickly Cassava can address the FDA’s concerns and complete the regulatory review process.
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