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News about "FDA Breakthrough Designation "

AXS-05 by Axsome Therapeutics Advances as Novel Multimodal Therapy for CNS Disorders, Receives FDA Breakthrough Designation

Axsome Therapeutics’ investigational oral drug AXS-05 is advancing clinical development for Alzheimer’s disease agitation and smoking cessation, leveraging a unique multimodal mechanism targeting key neurotransmitter pathways.

FDA Breakthrough Designation | 03/01/2026 | By News Bureau

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