Cassava Shares Plunge 85% as Alzheimer Study Falls Short of Goals

Investing.com -- Cassava Sciences, Inc., a biotechnology company focused on Alzheimer’s disease treatments, announced that its Phase 3 ReThink-ALZ study for the investigational drug simufilam did not meet its targeted outcomes. The study aimed to improve cognitive function and abilities in patients with mild to moderate Alzheimer’s disease but failed to achieve primary, secondary, and exploratory biomarker endpoints.

Primary endpoints were based on changes in cognitive function and abilities from the start of the study to the end of the 52-week treatment period. These were assessed using the ADAS-COG12 and ADCS-ADL scales, comparing simufilam to a placebo. Despite the negative outcomes, simufilam demonstrated an overall favorable safety profile.

Rick Barry, Cassava's President and CEO, expressed disappointment on behalf of patients, families, and doctors seeking new treatment options. He noted that the cognitive decline in the placebo group was less severe compared to other Alzheimer’s studies, which was unexpected.

As a result of these findings, Cassava decided to terminate its second Phase 3 trial, ReFocus-ALZ, along with the Open Label Extension study. Detailed analyses of the full dataset from the 52-week period and a significant portion of the 76-week data will be reported in the future.

Barry also extended his gratitude to the patients, families, caregivers, staff, researchers, site coordinators, and partners involved in the clinical program, expressing hope that the data from the studies will contribute to future Alzheimer’s research.

Following the announcement, Cassava Sciences' shares plummeted by 85% on Monday. In response to the study's outcome, Rodman & Renshaw analyst Elemer Piros downgraded Cassava Sciences' rating from Buy to Sell and cut the new price target from $107.00 to $2.00.

Piros justified the new price target by equating it with Cassava’s estimated cash position of about $100 million over the next 12 months.