Axsome Stock Hits Record High on Dual FDA Boost for Pipeline Drugs
Shares surge over 18% after the FDA grants Priority Review for its Alzheimer's agitation drug and supports a regulatory filing for its narcolepsy treatment.
Axsome Therapeutics (NASDAQ: AXSM) saw its shares jump more than 18% to a record high on Tuesday after the biopharmaceutical company announced two significant regulatory advancements for key drugs in its central nervous system (CNS) pipeline.
The New York-based company's stock climbed to $176.62 in midday trading, blowing past its previous 52-week high, as investors reacted to positive news from the U.S. Food and Drug Administration (FDA) for its treatments targeting Alzheimer's disease agitation and narcolepsy.
In a major development, Axsome announced that the FDA has accepted its supplemental New Drug Application (sNDA) for AXS-05 for the treatment of agitation in patients with Alzheimer's disease. The agency granted the application Priority Review, a designation reserved for drugs that, if approved, would represent a significant improvement in the safety or effectiveness of treating a serious condition. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2026.
"The FDA's acceptance of the sNDA for Priority Review marks a key step toward potentially offering a new treatment for the millions of Americans living with Alzheimer's disease who experience agitation," the company stated in a press release. AXS-05, which has already received Breakthrough Therapy designation for this indication, could address a substantial unmet need, as agitation is one of the most distressing and difficult-to-manage symptoms of Alzheimer's.
Adding to the bullish momentum, Axsome also confirmed it had received supportive feedback from the FDA during a pre-NDA meeting for another promising candidate, AXS-12, a treatment for narcolepsy. According to the company, the meeting minutes support the planned submission of a New Drug Application for AXS-12 in January 2026. Narcolepsy is a chronic neurological condition characterized by overwhelming daytime sleepiness.
AXS-12 has also been granted Breakthrough Therapy designation and holds Orphan Drug Designation, which provides incentives for the development of drugs for rare diseases. These dual catalysts signal a significant de-risking of two high-value assets in Axsome's late-stage pipeline, pushing its market capitalization to over $7.6 billion.
The market's enthusiastic response underscores the potential commercial opportunity for both treatments. Wall Street remains highly optimistic about the company's prospects. Based on 20 analyst ratings, the consensus view is a 'Strong Buy,' with a collective price target of approximately $181.59, suggesting further upside even after Tuesday's rally. The company's pipeline progress gives it multiple shots on goal in the lucrative CNS market.
These recent developments build on Axsome's strategy of developing novel therapies for CNS disorders where treatment options are limited. The company is advancing a portfolio that includes candidates for depression, migraine, and other neurological conditions. The positive regulatory feedback for both AXS-05 and AXS-12 now sets a clear timeline for potential approvals and commercial launches, providing investors with key milestones to watch over the next 12 to 18 months. As reported by MarketWatch, the twin announcements provide a clearer path forward for two of the company's most-watched pipeline candidates.
With a PDUFA date now on the calendar for its Alzheimer's drug and a clear path to file its narcolepsy treatment, Axsome Therapeutics has solidified its position as a leading innovator in the CNS space, with the potential to deliver transformative therapies to patients and significant returns to investors.