Axsome Therapeutics, Inc. - Common Stock (AXSM)

NEW YORK, March 05, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM) (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 Hikma Pharmaceuticals USA, Inc. (Hikma) resolving patent litigation related to Axsome’s product Sunosi® (solriamfetol). The litigation, which is pending in the United States District Court for the District of New Jersey, resulted from submission by Hikma of an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market a generic equivalent of Sunosi in the United States. Under the terms of the settlement agreement, Axsome will grant Hikma a license to sell its generic version of Sunosi beginning on or after September 1, 2040, if pediatric exclusivity is granted for Sunosi, or on or after March 1, 2040, if no pediatric exclusivity is granted, subject to FDA approval and conditions and exceptions customary for agreements of this type.

Supplemental New Drug Application (sNDA) submission anticipated in 3Q 2025

TD Cowen 45th Annual Health Care Conference on March 4 in Boston

SYMBRAVO demonstrated statistically significantly greater migraine treatment response compared to prior treatment with an oral CGRP inhibitor (p<0.001, mTOQ-4 total score, primary endpoint)

Total 4Q and full year 2024 net product revenue of $118.8 million and $385.7 million, respectively, representing 66% and 88% year-over-year growth

NEW YORK, Feb. 10, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM) (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. Food and Drug Administration (FDA) seeking approval to market a generic version of AUVELITY in the United States prior to the expiration of applicable Axsome patents.

NEW YORK, Jan. 31, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), 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.

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

NEW YORK, Jan. 22, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), 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.

Auvelity preliminary 4Q and full year 2024 net product sales of $92.6 million and $291.4 million, respectively

ACCORD-2 Phase 3 trial in Alzheimer’s disease agitation achieves primary endpoint compared to placebo (p=0.001, time to relapse)

AXS-12 statistically significantly reduced the frequency of cataplexy attacks compared to placebo (p=0.017, primary endpoint)

Total 3Q 2024 net product revenue of $104.8 million, representing 81% year-over-year growth

NEW YORK, Nov. 08, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced eight presentations spanning its innovative portfolio of late-stage products and product candidates in psychiatry and neurology at NEI Congress 2024, being held Nov. 7 - Nov. 10, 2024, in Colorado Springs, Colorado.

NEW YORK, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced seven presentations from across its broad portfolio of innovative neuroscience products and product candidates at Psych Congress 2024, being held Oct. 29 - Nov. 2, 2024, in Boston, Massachusetts.

NEW YORK, Oct. 15, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, will report its financial results for the third quarter of 2024 on Tuesday, November 12, 2024, 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.

Seven presentations highlight the Company’s growing CNS portfolio and commitment to improving treatment outcomes for patients with sleep disorders

FDA sets PDUFA action goal date of January 31, 2025

Morgan Stanley 22nd Annual Global Healthcare Conference on September 4 in New York

NEW YORK, Aug. 21, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system disorders, today announced that it has reached agreement with Sandoz Inc. (Sandoz) to dismiss the patent litigation related to Axsome’s product Sunosi® (solriamfetol). The litigation, which was pending in the United States District Court for the District of New Jersey, resulted from submission by Sandoz of an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration seeking approval to market a generic equivalent of Sunosi in the United States. Sandoz withdrew its ANDA for a generic equivalent of Sunosi, and, as a result, the litigation has been dismissed without prejudice.        

In a groundbreaking study, Chinese scientists have revealed that classical music could be a powerful tool in the fight against treatment-resistant depression, a condition that affects nearly 50% of patients with major depressive disorder (MDD). Published in Cell Reports, the research demonstrates that music can synchronize neural circuits in the brain, leading to significant antidepressant … Continue reading "New Study Reveals How Classical Music Could Revolutionize Depression Care"

NEW YORK, Aug. 10, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Axsome Therapeutics, Inc. (NASDAQAXSM) on behalf of long-term stockholders following a class action complaint that was filed against Axsome on May 13, 2022 with a Class Period from December 30, 2019 to April 22, 2022. Our investigation concerns whether the board of directors of Axsome have breached their fiduciary duties to the company.

Total 2Q 2024 net product revenue of $87.2 million, representing 87% year-over-year growth

EQNX::TICKER_START (NASDAQTNXP),NYSE:PFENYSEPFE)(NYSE:LLYNYSELLY,(NYSE:ABBVNYSE),(NASDAQ:AXSMAXSM) EQNX::TICKER_END

PALM BEACH, Fla., July 25, 2024 (GLOBE NEWSWIRE) -- FN Media Group News Commentary - The fibromyalgia treatment market has witnessed positive growth trends over the past few years. There is higher disease awareness due to growth in diagnosis rates and growing awareness and concern for this serious, debilitating condition. Moreover, rising healthcare expenditure and presence of favorable reimbursement policies are also contributing to the market expansion. New drugs in development having novel mechanisms of actions for this condition are further expected to bring more growth opportunities for this market in the near future. The fibromyalgia treatment market involves prescription drugs and non-prescription remedies that provide relief from fibromyalgia, a chronic condition characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues. This market includes drugs like antidepressants, pain relievers and anti-seizure medications as well as non-drug options like physical therapy, osteopathic manipulation, massage therapy and cognitive behavioral therapy which are aimed at managing fibromyalgia symptoms and improving overall health and quality of life for sufferers. A report from Coherent Market Insights projected that the fibromyalgia treatment market is estimated to be valued at USD 3.07 Billion in 2024 and is expected to reach USD 3.86 Billion by 2031, exhibiting a compound annual growth rate (CAGR) of 3.3% from 2024 to 2031. Active biotech, pharma companies in the markets this week include: Tonix Pharmaceuticals Holding Corp. (NASDAQTNXP), Pfizer Inc. NYSE: PFENYSEPFE)(NYSE: LLYNYSELLY, AbbVie (NYSE: ABBVNYSE), Axsome Therapeutics, Inc. (NASDAQ: AXSMAXSM).