About Axsome Therapeutics, Inc. - Common Stock (AXSM)
Axsome Therapeutics is a clinical-stage biopharmaceutical company focused on the development of innovative therapies for the treatment of central nervous system (CNS) disorders. The company’s research is centered on addressing some of the most challenging conditions in mental health and neurological disorders, including depression, migraine, and Alzheimer’s disease. Axsome is dedicated to advancing its pipeline of drug candidates through rigorous clinical trials with the goal of providing new and effective treatment options to patients and improving their quality of life. Through its commitment to science and patient care, Axsome aims to make significant contributions to the field of CNS therapeutics. Read More
The regulator said that upon preliminary review, it found that the new drug application for AXS-14 was not sufficiently complete to permit a substantive review.
NEW YORK, June 09, 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 has received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for AXS-14 (esreboxetine) for the management of fibromyalgia.
NEW YORK, May 29, 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 that it will participate in three upcoming investor conferences in June:
NEW YORK, May 28, 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 presentations from three of its innovative neuroscience programs at the American Society of Clinical Psychopharmacology (ASCP) 2025 Annual Meeting, being held from May 27-30 in Scottsdale, Arizona.
NEW YORK, May 27, 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 Hetero Labs Ltd. and certain of its affiliates (Hetero) 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 Hetero of an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market a generic version of SUNOSI in the United States. Under the terms of the settlement agreement, Axsome will grant Hetero 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.
Axsome beat Q1 expectations with $121.5 million in revenue and strong Auvelity sales as it prepares Symbravo's U.S. launch and advances key drug programs.
NEW YORK, May 01, 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 is joining with Mental Health America (MHA) and the broader mental health advocacy community in a consolidated effort to raise awareness and promote action during May’s Mental Health Month.
NEW YORK, April 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 that it will participate in four upcoming investor conferences in May:
