Axsome Therapeutics Inc.
Axsome Therapeutics' NDA for AXS-12 Accepted by FDA for Cataplexy in Narcolepsy Treatment
Summary
On July 15, 2026, Axsome Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027. AXS-12 is a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator under development for the treatment of narcolepsy, a serious and debilitating orphan neurological condition characterized by excessive daytime sleepiness, cataplexy, hypnagogic hallucinations, sleep paralysis, and disrupted nocturnal sleep. Cataplexy, seen in an estimated 70% of narcolepsy patients, is a sudden reduction or loss of muscle tone while awake, typically triggered by strong emotions. AXS-12 has been granted U.S. Food and Drug Administration (FDA) Orphan Drug Designation for the treatment of narcolepsy.
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About Axsome Therapeutics Inc.
Axsome Therapeutics Inc. specializes in the development and commercialization of transformative therapies for central nervous system (CNS) disorders. The company's focus is on addressing unmet medical needs in the fields of depression, migraines, and agitation associated with Alzheimer's disease, among other CNS conditions. Axsome's robust pipeline includes both clinical and preclinical stage compounds, highlighting a commitment to innovation and efficacy. By utilizing novel mechanisms of action, their product candidates aim to offer significant advantages over existing treatments. Axsome Therapeutics plays a crucial role in the pharmaceutical and healthcare sectors, helping reshape treatment paradigms for complex and challenging CNS disorders. Through strategic collaborations and leveraging cutting-edge research methods, the company seeks to provide effective healthcare solutions and improve quality of life for patients globally. Established on a vision to impact lives positively, Axsome continues to advance its clinical programs and regulatory approvals, thereby reinforcing its position in the biotechnology industry.
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