NEW YORK, Feb. 10, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM) (Axsome), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that it has entered into a settlement agreement with Teva Pharmaceuticals, Inc. (Teva) resolving all patent litigation related to Axsome's AUVELITY® (dextromethorphan HBr – bupropion HCl) product. The litigation resulted from submission by Teva of an Abbreviated New Drug Application to the U.S. ...

Axsome Therapeutics, Inc. (AXSM) announced that the FDA has approved Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults.Per the company, Symbravo, a novel, oral medicine, offers a multi-mechanistic approach to treating migraine. It targets multiple pathways underlying a migraine attack.AXSM expects to launch Symbravo in the United States in about four months.Shares of AXSM were up 3.5% on Jan. 30 following the news announcement.The stock has rallied 20.8% ...

NEW YORK, Jan. 31, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, will host a virtual investor event and conference call today at 8:00 AM Eastern Time to discuss the U.S. Food and Drug Administration (FDA) approval of SYMBRAVO®, a novel multi-mechanistic approach to treating migraine that targets multiple pathways underlying a migraine attack. Experience the interactive Multimedia New ...

A single oral dose of SYMBRAVO provided rapid migraine pain freedom and return to normal functioning within 2 hours, and sustained efficacy through 24 and 48 hours 85% and 77% of patients treated with a single dose of SYMBRAVO did not require migraine rescue medication within 24 hours in two Phase 3 studies SYMBRAVO demonstrated superior efficacy across a broad range of migraine severity (mild, moderate, and severe), and in head-to-head evaluation SYMBRAVO incorporates Axsome’s rapid absorption technology a ...

Axsome Therapeutics’ (AXSM) shares have rallied 19.4% in the past month against the industry’s decrease of 0.2%, driven by investor enthusiasm about the company’s encouraging preliminary sales numbers for the fourth quarter and full year 2024.Axsome’s commercial portfolio includes Auvelity (AXS-05) which was launched in the United States in 2022 to treat major depressive disorder. It was the company’s first approved drug.The company is conducting several label expansion studies on Auvelity targeting other c ...

NEW YORK, Jan. 22, 2025 (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 fourth quarter and full year of 2024 on Tuesday, February 18, 2025, 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. To parti ...

Axsome Therapeutics (AXSM) shares ended the last trading session 11.5% higher at $89.27. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 11.2% loss over the past four weeks.The stock rallied after the company announced robust preliminary net product revenues for its marketed drugs, Auvelity and Sunosi, for the fourth quarter and full year 2024. Auvelity sales in the fourth quarter of 2024 are expected to be around ...

Financial Performance - Axsome Therapeutics reported preliminary net revenue for Q4 2024 at $50 million, representing a 25% increase year-over-year[6]. - For the full year 2024, the company achieved net revenue of $180 million, up 30% compared to 2023[6]. - The company anticipates continued growth in 2025, projecting net revenue to reach between $220 million and $250 million, indicating a growth rate of 22% to 39%[6]. Product Development and Innovation - Axsome Therapeutics is focusing on expanding its product pipeline, with two new drug candidates expected to enter clinical trials in 2025[6]. - The company emphasized its commitment to innovation and research, allocating 20% of its revenue towards R&D initiatives[6]. - Axsome Therapeutics is investing in new technology for drug development, aiming to improve efficiency and reduce time to market[6]. Market Strategy - The company plans to enhance its market presence through strategic partnerships and collaborations in the upcoming year[6]. - Axsome Therapeutics aims to expand its international market presence, targeting key regions in Europe and Asia for growth[6]. - Axsome Therapeutics is exploring potential acquisition opportunities to bolster its product offerings and market reach[6]. Clinical Studies - The company reported an increase in user data, with a 15% rise in patient enrollment for ongoing clinical studies[6].

Auvelity preliminary 4Q and full year 2024 net product sales of $92.6 million and $291.4 million, respectively Sunosi preliminary 4Q and full year 2024 net product revenue of $25.7 million and $93.8 million, respectively NEW YORK, Jan. 13, 2025 (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 preliminary net product revenue for the fourth quarter and full year ended December ...

ACCORD-2 Phase 3 trial in Alzheimer’s disease agitation achieves primary endpoint compared to placebo (p=0.001, time to relapse) ACCORD-2 Phase 3 trial achieves key secondary endpoint compared to placebo (p=0.001, prevention of relapse of Alzheimer’s disease agitation) AXS-05 reduced worsening of Alzheimer’s disease overall compared to placebo in ACCORD-2 Phase 3 trial (p<0.001, CGI-S Alzheimer’s disease overall clinical status) ADVANCE-2 trial did not demonstrate statistical significance on primary endpoin ...