News & Events zu Axsome Therapeutics, Inc. (AXSM)AXSMAxsome Therapeutics, Inc.

Axsome Reports Q2 Revenue of $218.38M, Below Expectations

Reports Q2 revenue $218.38M, consensus $221.78M. "The second quarter was highly productive for Axsome. Our commercial business grew robustly, driven by strong underlying demand for our products, and we made important regulatory and clinical progress across our innovative neuroscience pipeline," said Herriot Tabuteau, Chief Executive Officer of Axsome Therapeutics. "We expect our commercial momentum to build over the balance of the year, in particular with anticipated continued Auvelity growth in Alzheimer's disease agitation and major depressive disorder. With a focus on commercial execution and advancement of our broad late-stage neuroscience pipeline targeting high unmet needs, novel indications, first-in-class mechanisms of action, and best-in-class product profiles, Axsome is well positioned to deliver substantial value to patients and shareholders."

Axsome Therapeutics AXS-12 New Drug Application Accepted by FDA

Axsome Therapeutics announced that the FDA has accepted for filing the company's new drug application for AXS-12 for the treatment of cataplexy in narcolepsy. The FDA has set a Prescription Drug User Fee Act target action date of May 1, 2027. The FDA also indicated that it does not currently plan to hold an advisory committee meeting to discuss the application.

Axsome Therapeutics Doses First Patient in FOCUS-3 Trial

Axsome Therapeutics announced that the first patient has been dosed in the FOCUS-3 Phase 3 trial evaluating solriamfetol as a treatment for adolescents with attention deficit hyperactivity disorder, or ADHD.