NEW YORK, December 31, 2025, 14:41 ET — Regular session
- Axsome Therapeutics shares were up about 23% in afternoon trading after the FDA accepted its AXS-05 filing for Alzheimer’s disease agitation with Priority Review. 1
- The FDA set an April 30, 2026 PDUFA target action date, and Axsome said Priority Review carries a six-month review goal. 1
- Oppenheimer raised its price target to $220 and pointed to a second near-term catalyst: Axsome’s planned January NDA submission for AXS-12 in narcolepsy. 2
Axsome Therapeutics shares jumped 23% in afternoon trading on Wednesday after the company said U.S. regulators accepted its application and granted a faster review for AXS-05 to treat agitation in Alzheimer’s disease. 1
The FDA’s acceptance puts a hard deadline on the next major catalyst for Axsome, with an April 30, 2026 decision target that brings clarity to the company’s regulatory timeline. The stock move also stood out against the broader biotech group, which was modestly higher. 1
Axsome said the FDA granted “Priority Review,” meaning the agency’s goal is to take action within six months, versus about 10 months under a standard review. The April 30 date is the agency’s PDUFA target action date — the deadline it sets for completing a review under the Prescription Drug User Fee Act. 1
The company also said it received formal pre-NDA meeting minutes from the FDA supporting an NDA submission for AXS-12 in narcolepsy, and it expects to complete that filing in January 2026. A pre-NDA meeting is typically used to align with the FDA on what will go into a planned marketing application. 3
Oppenheimer analyst Jay Olson raised his price target on Axsome to $220 from $190, calling the FDA’s acceptance “the best-case scenario,” and said the earlier-than-standard timeline should pull forward launch preparations ahead of the April 2026 decision date. 2
If cleared, AXS-05 would enter a market with limited approved options. The FDA approved Otsuka and Lundbeck’s Rexulti in 2023 as the first drug for agitation symptoms associated with dementia due to Alzheimer’s disease. 4
Axsome’s AXS-05 is a combination of dextromethorphan and bupropion, and the company said the supplemental application is supported by a clinical program that included four Phase 3 trials and a long-term safety trial in Alzheimer’s disease agitation. Axsome also noted the FDA previously granted Breakthrough Therapy designation to AXS-05 for this use in 2020, a status intended to speed development and review for certain treatments. 1
On AXS-12, Axsome said FDA feedback indicated its regulatory data package would be sufficient for an NDA submission for treating cataplexy in narcolepsy. Cataplexy is a sudden loss of muscle tone while awake, often triggered by strong emotions, the company said. 3
Axsome added that AXS-12 has Orphan Drug Designation for narcolepsy, which can provide incentives such as seven years of U.S. marketing exclusivity if the drug is approved for the designated indication. 3
Axsome shares were up about 23.0% at $183.08, after swinging between $148.79 and $184.40 on the session. About 2.4 million shares had changed hands, while the SPDR S&P Biotech ETF was up about 0.4%.
Investors are now watching two dates set by the company: the planned January filing for AXS-12 and the April 30, 2026 FDA decision target for AXS-05 in Alzheimer’s agitation. Analysts will also watch for any signals on launch readiness and payer positioning as the FDA review progresses. 2
Axsome focuses on central nervous system conditions and said its portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness tied to narcolepsy and obstructive sleep apnea, and migraine. It sells Sunosi, Auvelity and Symbravo, the company said. 3
