Cassava Sciences Faces FDA Request for More Data on Simufilam Epilepsy Trial

Reuters12-03

Cassava Sciences Faces FDA Request for More Data on Simufilam Epilepsy Trial

Cassava Sciences Inc. has submitted an investigational new drug $(IND)$ application to the U.S. Food and Drug Administration (FDA) for a proposed proof-of-concept clinical trial of simufilam in tuberous sclerosis complex (TSC)-related epilepsy. The FDA has requested additional information from the company to assess potential risks and support the initiation of the study. Cassava Sciences expects to receive a formal letter from the FDA detailing the required steps to address these issues and plans to work collaboratively with the agency, aiming to begin the trial in the first half of 2026.

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: 0001437749-25-036710), on December 03, 2025, and is solely responsible for the information contained therein.

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