Cassava's Phase 3 REFOCUS-ALZ Study Fails To Meet Prespecified Endpoints, Stock Down

(RTTNews) - Cassava Sciences, Inc. (SAVA), Tuesday announced that the Phase 3 REFOCUS-ALZ study of simufilam in mild-to-moderate Alzheimer's disease failed to meet each of the prespecified co-primary, secondary and exploratory biomarker endpoints.

REFOCUS-ALZ enrolled 1,125 patients and was discontinued on November 25, 2024, following the report that a prior 52-week Phase 3 study, RETHINK-ALZ, did not meet its co-primary endpoints.

The findings revealed that Simufilam did not show a significant reduction in co-primary endpoints of cognitive or functional decline versus placebo in patients with mild-to-moderate Alzheimer's disease

However, Simufilam continued to demonstrate an overall favorable safety profile

CEO Rick Barry confirmed that the company will discontinue all efforts to develop simufilam for Alzheimer's disease, eventually phasing out the program by the end of Q2 2025.

"While we have initiated preclinical studies to evaluate simufilam's potential as a treatment for TSC-related epilepsy, we maintain ongoing strategic expense management efforts," Barry added.

As of December 31, 2024, the company has approximately $128.6 million in cash and cash equivalents.

Currently, Cassava's stock is falling 17.55 percent, to $2.30 on the Nasdaq.