Cassava Sciences (SAVA) said in a filing the FDA has asked for more information before allowing its investigational new drug application for simufilam in tuberous sclerosis complex-related epilepsy to move forward.
The agency needs additional details to evaluate potential risks and support the start of the proposed clinical study.
Cassava expects a formal letter outlining the FDA’s concerns and the steps required to address them. The company still aims to begin its proof-of-concept trial in the first half of 2026.
SAVA shares initially dropped as much as 13% premarket before recovering to trade up 1%.
