Sage Therapeutics Stock Declines Following Disappointing Alzheimer’s Trial Results

Sage Therapeutics experienced a significant decline in its stock, with shares dropping as much as 25% in premarket trading, following the release of disappointing topline results from its Phase 2 LIGHTWAVE study. This trial evaluated dalzanemdor (SAGE-718) as a treatment for mild cognitive impairment (MCI) and mild dementia associated with Alzheimer’s disease (AD).

The study did not meet its primary endpoint, revealing no statistically significant difference between the effects of dalzanemdor and a placebo. The LIGHTWAVE study was designed as a 12-week, randomized, double-blind, placebo-controlled trial to assess cognitive function improvements using the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) Coding Test.

Results indicated that participants receiving dalzanemdor showed no meaningful improvement when compared to those on the placebo. Additionally, exploratory endpoints—such as the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and the Montreal Cognitive Assessment (MoCA)—also failed to show significant benefits.

In light of these findings, Sage Therapeutics announced it would cease further clinical development of dalzanemdor for Alzheimer’s disease. However, the company remains committed to advancing its research initiatives, with the results from the Phase 2 DIMENSION study—focused on cognitive impairment related to Huntington’s disease—expected later this year.

Barry Greene, CEO of Sage Therapeutics, expressed disappointment over the LIGHTWAVE study results but extended gratitude to participants, investigators, caregivers, patient advocates, and the Alzheimer’s community for their support in this important research. He emphasized the hope that their work and findings will contribute to future research endeavors.

Despite the challenges faced, Sage noted that dalzanemdor was generally well-tolerated throughout the study, with no new safety concerns being reported.