Core Viewpoint - Axsome Therapeutics has experienced a significant stock increase of 55% year-to-date, raising questions about its long-term performance potential and investment viability [1] Recent Developments - Axsome settled a patent lawsuit with Teva Pharmaceutical regarding Auvelity, a treatment for major depressive disorder, resulting in a 25% stock surge in one day [2] - The settlement prevents Teva from launching a generic version of Auvelity until at least 2038, providing a substantial advantage for Axsome and its shareholders [3] Product Line and Financial Outlook - Axsome's product lineup includes Auvelity, Sunosi for narcolepsy, and the newly approved Symbravo for migraines, contributing to strong revenue growth [4] - The company anticipates product revenue of $385.2 million for 2024, representing a 42% increase from the previous year's total revenue of $270.6 million [4][5] Clinical and Regulatory Progress - Axsome plans to submit Auvelity for FDA approval as a treatment for Alzheimer's disease agitation in the second half of the year, following mixed results from phase 3 trials [6][7] - The investigational drug AXS-12 has successfully completed a phase 3 study for narcolepsy and received orphan drug designation from the FDA [8] Future Prospects - Axsome expects late-stage clinical trial results for Sunosi in major depressive disorder and ADHD in early 2025, along with regulatory submissions for AXS-14 in fibromyalgia [9] - The company could launch at least one new product and gain a key indication for Auvelity within the next 18 months, with potential for additional new medicines in the following three years [10]

Core Viewpoint - Axsome Therapeutics' stock has seen a significant increase following the settlement of a key litigation, which enhances its market position and attractiveness to potential partners [1][2][3]. Group 1: Stock Performance - Axsome's shares rose by 4.1% as of 10:20 a.m. ET, with an earlier peak of 5.6%, contrasting with declines in the S&P 500 and Nasdaq Composite [1]. Group 2: Legal Settlement - The company settled a lawsuit with Teva Pharmaceuticals, which had sought FDA approval for a generic version of Axsome's drug Auvelity, thus protecting Axsome's exclusive rights for approximately 14 years [2]. Group 3: Analyst Reactions - Mizuho's analyst Graig Suvannavejh raised Axsome's price target from $137 to $195 per share, citing reduced uncertainty and increased attractiveness for strategic partnerships [3]. - Following the settlement, other analysts on Wall Street have also revised their price targets positively for Axsome [4].

Axsome Therapeutics (AXSM) is expected to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended December 2024. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.The earnings report, which is expected to be released on February 18, 2025, might help the stock move higher if these key numbers are be ...

Shares of Axsome Therapeutics (AXSM) jumped 20.2% on Monday after the company announced that it has entered into a settlement agreement with Teva Pharmaceuticals (TEVA) related to patents for the psychiatry drug, Auvelity.The settlement agreement resolves the patent litigation brought by Axsome on Teva for submitting an abbreviated new drug application to the FDA, seeking marketing approval for a generic version of Auvelity in the United States before applicable patents expire.Auvelity is approved for the t ...

Axsome Therapeutics (AXSM) shares soared 20.2% in the last trading session to close at $127.08. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 32.1% gain over the past four weeks.The sudden rise in the stock price was observed after Axsome announced that it has entered into a settlement agreement with Teva Pharmaceuticals regarding the Auvelity (dextromethorphan HBr – bupropion HCl) patent litigation. The settlement agreement re ...

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 ...