NEW YORK, Jan. 27, 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 fourth quarter and full year 2025 on Monday, February 23, 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. To participa ...

Key Takeaways Axsome's lead drug Auvelity has been the primary driver of top-line growth since its U.S. launch.Auvelity posted $352M in sales in the first nine months of 2025, which increased 77% year over year.Axsome's sNDA for AXS-05 in Alzheimer's disease agitation has an FDA decision set for April 2026.Axsome Therapeutics (AXSM) has been witnessing a strong sales uptake for its lead marketed drug, Auvelity (AXS-05), which is approved for treating major depressive disorder. Since its launch in the United ...

Dubai-based investor focused on building a resilient, income-generating portfolio with a long-term growth mindset. My approach is primarily long-only, blending dividend-paying equities, REITs, and other income strategies with selective growth opportunities. I believe in disciplined, fundamentals-driven investing, prioritizing capital preservation while compounding returns over time. Originally from India.Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies ...

Core Viewpoint - The investor is focused on building a resilient, income-generating portfolio with a long-term growth mindset, emphasizing disciplined, fundamentals-driven investing and capital preservation while compounding returns over time [1]. Group 1: Investment Strategy - The investment approach is primarily long-only, blending dividend-paying equities, REITs, and other income strategies with selective growth opportunities [1]. - The investor prioritizes capital preservation alongside the compounding of returns over time [1]. Group 2: Background - The investor is based in Dubai and originally from India, indicating a diverse geographical perspective in investment strategies [1].

Axsome Therapeutics Inc. (NASDAQ:AXSM) is one of the best mid-cap growth stocks to buy right now. On January 16, Piper Sandler raised its price target on Axsome Therapeutics to $223 from $148 with an Overweight rating. Piper Sandler is confident in Auvelity’s commercial potential, particularly given the highly likely FDA label expansion into Alzheimer’s agitation expected by April 30 this year. The optimism is further supported by the drug’s sustained momentum in the depression market and a long-term paten ...

Axsome Therapeutics (AXSM) shares soared 4.1% in the last trading session to close at $184.5. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 14.6% gain over the past four weeks.Axsome Therapeutics’ stock price gain can be attributed to the announcement of preliminary fourth-quarter and full Year 2025 sales figures for its marketed products. Additionally, AXSM announced the initiation of the phase III study called FORWARD with th ...

Core Insights - Axsome Therapeutics (AXSM) has initiated a phase III study named FORWARD to evaluate AXS-14 (esreboxetine) for managing fibromyalgia, marking a significant step in its drug development process [1][8] - AXS-14 is an investigational oral drug aimed at increasing norepinephrine levels in the brain to alleviate chronic pain and related symptoms associated with fibromyalgia [1] Study Details - The FORWARD study is a phase III double-blind, placebo-controlled withdrawal trial involving patients with fibromyalgia, where participants who respond to treatment during a 12-week open-label period will be randomized to either continue AXS-14 at 8 mg once daily or switch to placebo for up to 12 weeks [2] - The primary endpoint of the study is to measure the time from randomization to the loss of therapeutic response [2][8] Market Performance - Over the past year, AXSM's shares have increased by 89.4%, significantly outperforming the industry average rise of 18.7% [3] Regulatory Background - Axsome submitted a new drug application (NDA) for AXS-14 for fibromyalgia in May 2025, which was delayed from an earlier timeline of the first quarter of 2024 [5] - In June 2025, the FDA issued a Refusal to File (RTF) letter regarding the NDA, citing inadequacies in one of the placebo-controlled studies, prompting Axsome to initiate the FORWARD study to address these concerns [6][8] Disease Context - Fibromyalgia is a chronic neurological pain disorder affecting approximately 17 million people in the United States, characterized by widespread pain, fatigue, sleep disturbances, and other symptoms [7]

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NEW YORK, Jan. 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 the first patient has been dosed in the FORWARD Phase 3 trial of AXS-14 (esreboxetine) for the management of fibromyalgia. FORWARD (Fibromyalgia Response with Esreboxetine Evaluated Using a Randomized Withdrawal Research Design) is a Phase 3, double-blind, placebo-controlled, multicenter, randomized wit ...

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