Why Axsome Therapeutics Stock Rocketed Higher to End 2025

Core Insights - Axsome Therapeutics shares experienced a significant increase, closing the year with a rise of over 20% following the announcement of key developments [1] Group 1: FDA Approvals and Designations - The U.S. FDA granted priority review designation for Axsome's AXS-05 drug, aimed at treating agitation in Alzheimer's disease, which addresses a significant unmet medical need [3][4] - AXS-05 is already approved for major depressive disorder (MDD) and has seen a 69% year-over-year sales growth in Q3, contributing to 80% of Axsome's revenue for that quarter [3][8] - The FDA has set a target action date of April 30, 2026, for AXS-05, providing a clear timeline for potential market entry [4] Group 2: Pipeline Developments - Axsome's AXS-12, a drug for treating narcolepsy, is also progressing, with FDA meeting minutes indicating that the regulatory data package is acceptable for a new drug application (NDA) submission expected next month [5][6] - The positive news regarding both AXS-05 and AXS-12 has led to increased investor interest in Axsome stock [6]