Axsome Therapeutics Inc.
FDA Issues Refusal to File for Axsome's NDA for AXS-14 for Fibromyalgia
Summary
Axsome Therapeutics, Inc. announced on June 9, 2025, that the FDA issued a Refusal to File (RTF) for its New Drug Application (NDA) for AXS-14, an investigational treatment for fibromyalgia. The FDA found the NDA incomplete, specifically citing issues with the second placebo-controlled trial's design. Axsome plans to conduct an additional controlled trial to address the FDA's feedback, with initiation expected in the fourth quarter of 2025.
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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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