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.
Axsome's solriamfetol met primary and key secondary endpoints in a Phase 3 ADHD trial, showing significant symptom reduction and a favorable safety profile.
Demonstrated substantial and statistically significant improvement in ADHD symptoms as measured by the AISRS total score compared to placebo (p=0.039, primary endpoint, 150 mg solriamfetol)
NEW YORK, March 05, 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 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.
CEO Herriot Tabuteau struck an optimistic tone, citing strong commercial growth, a rapidly advancing pipeline, and the recent U.S. approval of Symbravo for migraine treatment.
Major U.S. indices are little-changed in Tuesday's midday trading as investors monitor recent geopolitical developments and anticipate the release of the latest FOMC minutes on Wednesday.
Axsome Therapeutics reports strong Q4 2024 revenues, driven by increased sales of Auvelity and Sunosi. Anticipated milestones and FDA approval for Symbravo make AXSM a top pick for 2025.
Under the settlement terms, Teva will receive a license to sell a generic version of Auvelity starting March 31, 2039, if pediatric exclusivity is granted.
Axsome settles Auvelity patent litigation with Teva, delaying a generic launch until 2038. Analysts see growth potential with Symbravo's migraine approval.
