AXSM

ARDX, BDORY and AXSM have been added to the Zacks Rank #5 (Strong Sell) List on July 29, 2026.

LEN, AXSM and SAM have been added to the Zacks Rank #5 (Strong Sell) List on July 27, 2026.

President Donald Trump has announced that all generic drugs imported into the United States would continue to enjoy a zero-percent tariff for another two years, sending major drug stocks up.

AXSM advances AXS-12 toward potential approval after the FDA accepts its NDA for cataplexy in narcolepsy and sets a May 2027 decision date.

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.

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.

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).