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Axsome Therapeutics Inc.
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Axsome Therapeutics Inc.

Axsome Therapeutics Initiates Phase 3 Trial for Solriamfetol in Major Depressive Disorder

| 8-K |Healthcare

Summary

On March 19, 2024, Axsome Therapeutics, Inc. announced the first patient has been dosed in the PARADIGM Phase 3 trial evaluating solriamfetol as a treatment for major depressive disorder (MDD). The trial, which will involve approximately 300 patients, aims to assess the efficacy and safety of solriamfetol over 6 weeks. The primary endpoint is the change in the Montgomery Åsberg Depression Rating Scale (MADRS). The full press release is filed as Exhibit 99.1.

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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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