Axsome Therapeutics

AXSM

Market cap $12.2B

FDA sets PDUFA target action date of May 1, 2027 NEW YORK, July 15, 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 that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027.

NEW YORK, July 14, 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 it will report its financial results for the second quarter of 2026 on Monday, August 10, 2026, before the opening of the U.S. financial markets. Axsome management will then host a conference call at 8:00 a.m. Eastern Time to discuss these results and provide a business update.

These three biotechs are posting strong revenue growth. Brand-new launches and label expansions should help them improve their lineups.

Axsome has a solid late-stage pipeline and growing commercialized drugs. Revolution aims to revolutionize cancer treatment, and a recent phase 3 trial shows it may be on the right path.

AXSM doses the first patient in the phase III FOCUS-2 study of solriamfetol for treating ADHD in children aged six to under 12 years.

The FOCUS-2 trial in children complements the recently announced FOCUS-3 trial in adolescents with ADHD NEW YORK, July 07, 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 that the first patient has been dosed in the FOCUS-2 Phase 3 trial evaluating solriamfetol as a treatment for children with attention deficit hyperactivity disorder (ADHD). FOCUS-2 (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol in children aged 6 to less than 12 years with ADHD.

Each of these biotech players has reached an important turning point. Recent drug approvals could supercharge the performance of one in particular.

Axsome specializes in central nervous system disorders, including depression, migraine, and fibromyalgia. Axsome's Auvelity recently won approval to treat agitation associated with Alzheimer's disease.

In this week's edition of InnovationRx, we look at Axsome's growing pipeline, HistoSonics innovative cancer treatment, state litigation over Medicaid work requirements, and more. To get it in your inbox, subscribe here.

NEW YORK, June 26, 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 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 (ADHD).