Cassava Sciences (SAVA, Financial) said Tuesday it will shut down its Alzheimer's disease program by the end of the second quarter after another Phase 3 trial failure for simufilam, its lead experimental therapy.
The announcement follows topline data from the discontinued REFOCUS-ALZ study, which showed simufilam did not meet any of its key endpoints—including primary, secondary, or exploratory biomarkers—in patients with mild-to-moderate Alzheimer's disease.
The company had already halted the REFOCUS-ALZ trial in November, shortly after the ReThink-ALZ study also failed to show benefit in the same patient group.
“Cassava will discontinue all efforts to develop simufilam for Alzheimer's disease,” CEO Rick Barry said. He noted the company aims to phase out the program by the end of Q2 2025.
Cassava has begun early-stage studies evaluating simufilam for Tuberous Sclerosis Complex-related epilepsy and continues to implement cost-cutting measures, Barry said.
Shares of the company fell about 19% in premarket trading Tuesday following the announcement.
