Cassava Sciences stock falls after FDA places clinical trial on hold

Investing.com -- Cassava Sciences Inc (NASDAQ:SAVA) stock tumbled 13.3% on Friday after the company disclosed that the U.S. Food and Drug Administration (FDA) has placed its proposed clinical trial for simufilam in tuberous sclerosis complex (TSC)-related epilepsy on full clinical hold.

The FDA’s formal letter, received by Cassava on December 15, 2025, requires the company to provide additional information, including pre-clinical data, and to modify the protocol design before the trial can proceed. As a result, Cassava no longer expects to initiate the proof-of-concept clinical trial in the first half of 2026 as previously planned.

The biotech company stated that it intends to "work expeditiously" to address the items identified in the FDA’s letter. However, the updated timing for the trial’s initiation will depend on Cassava’s ability to provide the requested information and the FDA’s subsequent review.

This setback affects Cassava’s plans to expand the potential applications of simufilam, its investigational drug candidate. The company had been looking to explore the drug’s efficacy in treating epilepsy associated with tuberous sclerosis complex, a rare genetic disorder that causes benign tumors to grow in various organs and can lead to seizures.

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