Cassava Sciences (NASDAQ:SAVA) slid 13% in early Monday trading after the company disclosed that the U.S. Food and Drug Administration has asked for more information related to its investigational new drug (IND) filing.
According to the company, the FDA notified Cassava on December 2 that it requires further data to evaluate potential risks to human participants in studies of simufilam, which the biotech is developing as a treatment for epilepsy associated with tuberous sclerosis complex (TSC). The IND application had been submitted to support a planned proof-of-concept clinical trial for this new indication.
Cassava said it expects a formal written communication outlining the specific deficiencies raised by regulators and intends to work with the FDA to address the issues.
Despite the request, the company reiterated that it still aims to begin its proof-of-concept study for simufilam in TSC-related epilepsy during the first half of 2026, suggesting the additional data requirement is not expected to materially alter its development schedule.
Tuberous sclerosis complex is a rare hereditary disorder that leads to benign tumor growth in multiple organs and frequently causes epilepsy and neurological difficulties.