FDA Puts Cassava Sciences Simufilam Trial on Full Clinical Hold

Reuters06:03

FDA Puts Cassava Sciences Simufilam Trial on Full Clinical Hold

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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Cassava Sciences Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001437749-25-038313), on December 18, 2025, and is solely responsible for the information contained therein.

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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.\n      \n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Cassava Sciences Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. 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