Axsome to Pursue FDA Approval for Alzheimer’s Agitation Treatment Despite Mixed Trial Results
Mixed Trial Results:
Axsome Therapeutics reported mixed results from two Phase 3 studies on Alzheimer's-related agitation, with one trial succeeding and the other failing3.
FDA Approval Plans:
Despite the mixed data, Axsome plans to file for FDA approval in the second half of 20253.
Current Treatment Gap:
There are currently no FDA-approved therapies for treating agitation in patients with Alzheimer's disease5.
Analyst Views:
Analysts from H.C. Wainwright and Leerink have noted the mixed data but see potential for approval and have even raised price targets for Axsome Therapeutics12.
AXS-05 Status:
AXS-05, the drug in question, has not been established as safe and effective for Alzheimer's disease agitation and is not yet approved by the FDA4.
Sources:
1. https://www.nasdaq.com/articles/axsome-data-mixed-sufficient-approval-says-hc-wainwright
2. https://www.nasdaq.com/articles/axsome-mixed-agitation-data-creates-most-confusion-says-leerink
3. https://endpts.com/despite-mixed-data-in-alzheimers-agitation-axsome-will-still-seek-fda-approval/
4. https://www.axsome.com/axs-portfolio/pipeline/about-axs-05
5. https://www.axsome.com/conditions/alzheimers-disease-agitation