Axsome Therapeutics, Inc. 8-K

What Happened
On December 31, 2025, Axsome Therapeutics, Inc. announced that the U.S. Food and Drug Administration accepted and granted Priority Review for its supplemental New Drug Application (sNDA) for the treatment of Alzheimer’s disease agitation. On the same date the company also announced it received formal pre‑NDA meeting minutes from the FDA regarding its planned NDA submission for AXS‑12 for narcolepsy. Both announcements were issued via press releases filed as Exhibits 99.1 and 99.2 to the company’s Form 8‑K.

Key Details

• Date of filings/announcements: December 31, 2025.
• Regulatory actions: FDA granted Priority Review for the sNDA for treatment of Alzheimer’s disease agitation; FDA provided formal pre‑NDA meeting minutes for AXS‑12 (narcolepsy).
• Documentation: Two press releases are attached as Exhibits 99.1 and 99.2 to the Form 8‑K.
• Form 8‑K signed by President & CEO Herriot Tabuteau, M.D.

Why It Matters
Priority Review is an FDA designation that generally shortens the review goal to six months (vs. about ten months under standard review), making this a potential near‑term regulatory catalyst for Axsome’s Alzheimer’s agitation program. Receiving formal pre‑NDA meeting minutes for AXS‑12 means the company has documented FDA feedback to inform its planned NDA submission for narcolepsy, which can help shape the content and timing of that filing. Both items are regulatory milestones investors watch for potential impact on development timelines and future commercialization prospects.