SAVA Stock Down as Alzheimer's Drug Fails in Second Late-Stage Study

Core Viewpoint - Cassava Sciences' lead drug candidate simufilam has failed to meet primary endpoints in two late-stage studies for Alzheimer's disease, leading to a significant drop in the company's stock price by 32.1% [1][2]. Company Summary - The phase III REFOCUS-ALZ study, which involved 1,125 patients with mild-to-moderate Alzheimer's disease, did not show a significant reduction in cognitive and functional decline compared to placebo over 76 weeks [2][3]. - The study also failed to meet any pre-specified secondary and exploratory biomarker endpoints, and the drug demonstrated an acceptable safety profile [2][3]. - Following the disappointing results, Cassava has decided to discontinue the REFOCUS-ALZ study and the open-label extension study [6]. Future Steps - Cassava plans to phase out its Alzheimer's disease program by the end of Q2 2025 and has initiated preclinical studies to explore simufilam's potential for treating tuberous sclerosis complex-related epilepsy [7]. - The company is also reducing its workforce by 33% in Q1 2025 as part of cost management efforts, which will incur a one-time cost of approximately $0.4 million [8]. Industry Context - Currently, there are two FDA-approved drugs for Alzheimer's disease: Leqembi and Kisunla, both targeting early symptomatic stages of the disease [9]. - These drugs work by reducing the accumulation of amyloid beta plaque in the brain, which is associated with cognitive decline in Alzheimer's patients [10].