Axsome: FDA approves AUVELITY for Alzheimer’s agitation

FDA approved AUVELITY for agitation associated with dementia due to Alzheimer’s disease, expanding its label from MDD to a second indication. The company states the commercial launch is on track for June 2026. This approval adds a new, first-in-class indication to the marketed product.

Key facts

Filed: May 4, 2026, 11:07 AM
Event: FDA approval
Direction: Positive
Company: AXSMAxsome
Asset: AXS-05
Source: SEC 8-K
Confidence: Sourced
Calendar: FDA decision (PDUFA) · Apr 30, 2026 · Approved

Source excerpt

EX-99.1 2 axsm-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Axsome Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update Total 1Q 2026 net product revenue of $191.2 million, representing 57% year-over-year growth AUVELITY ® 1Q 2026 net product sales of $153.2 million, representing 59% year-over-year growth SUNOSI ® 1Q 2026 net product revenue of $33.9 million, representing 34% year-over-year growth SYMBRAVO ® 1Q 2026 net product sales of $4.1 million AUVELITY approved for the treatment of agitation associated with dementia due to Alzheimer’s disease NDA for AXS-12 for the treatment of cataplexy in narcolepsy submitted to the FDA AXS-20 (balipodect), potentially first-in-class, pre-Phase 3, PDE10A inhibitor for schizophrenia and Tourette syndrome, added to pipeline Company to host conference call today at 8:00 AM Eastern NEW YORK, May 4, 2026 (Globe Newswire) – Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced financial results for the first quarter of 2026 and provided a general business update. “Axsome had a tremendous start to 2026. Our commercial business delivered robust year-over-year growth in the first quarter, Auvelity was approved by the FDA as a first-in-class medicine for the treatment of agitation associated with dementia due to Alzheimer’s disease, and we added a potentially first-in-class Phase 3-ready PDE10A inhibitor

SEC 8-K