Axsome Therapeutics, Inc.
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- Axsome Therapeutics, Inc. stands as a biopharmaceutical firm dedicated to developing innovative treatments for central nervous system (CNS) conditions within the United States. The company’s portfolio features marketed products including Auvelity (dextromethorphan HBr and bupropion HCl extended-release tablets), approved for adults experiencing major depressive disorder, and Sunosi (solriamfetol) for addressing excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. Additionally, Symbravo (meloxicam and rizatriptan) recently gained approval in early 2025 for the acute management of migraine with or without aura. Its advanced pipeline continues with AXS-05, currently under an sNDA review with the FDA for Alzheimer's disease agitation, and slated to commence a pivotal Phase 2/3 trial for smoking cessation in late 2025. The company is also progressing AXS-12, a selective norepinephrine reuptake inhibitor, with an NDA submission anticipated in late 2025 for narcolepsy, specifically to treat cataplexy. Another investigational medicine, AXS-14 (esreboxetine), is planned to enter Phase 3 trials for fibromyalgia in late 2025. Further expanding its therapeutic reach, Axsome recently acquired a subtype selective GABA-A receptor positive allosteric modulator for epilepsy in November 2025. The company, established in 2012, maintains its headquarters in New York, New York, focusing on delivering meaningful advancements in patient outcomes.
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