Axsome Therapeutics, INC 8-K filings

Axsome Therapeutics announced that AXS-12 met its primary endpoint in a Phase 3 trial, demonstrating a statistically significant reduction in cataplexy attacks compared to placebo in patients with narcolepsy.

Axsome Therapeutics announced a robust third quarter with significant revenue growth and advancements in its clinical pipeline, including upcoming data readouts and regulatory submissions.

Axsome Therapeutics has amended its loan agreement with Hercules Capital, increasing a tranche commitment, extending availability periods, and modifying performance covenants.

Axsome Therapeutics has announced the FDA's acceptance of their resubmitted New Drug Application for AXS-07, a potential treatment for acute migraine, with a PDUFA action goal date set for January 31, 2025.

Axsome Therapeutics has reached an agreement with Sandoz Inc. to dismiss patent litigation related to its product Sunosi, after Sandoz withdrew its application for a generic version.

Axsome Therapeutics announced a robust second quarter with significant revenue growth driven by Auvelity and Sunosi sales, along with advancements in their clinical pipeline.

Axsome Therapeutics held its 2024 annual meeting, electing two Class III directors, ratifying Deloitte & Touche LLP as its auditor, and approving executive compensation in a non-binding vote.

Axsome Therapeutics has reached a settlement with Unichem Laboratories, delaying the launch of a generic version of Sunosi until at least June 30, 2042.

Axsome Therapeutics announced a 160% year-over-year increase in total net product revenue for the first quarter of 2024, driven by strong sales of Auvelity and Sunosi, and provided updates on its clinical pipeline.

Axsome Therapeutics has commenced a Phase 3 clinical trial, named ENGAGE, to evaluate solriamfetol as a potential treatment for binge eating disorder in adults.

A recent survey by Axsome Therapeutics shows that a significant portion of narcolepsy type 1 patients continue to experience symptoms despite being on treatment.

Axsome Therapeutics announced that AXS-12 (reboxetine) significantly reduced cataplexy attacks compared to placebo in a Phase 3 trial for narcolepsy.

Axsome Therapeutics has begun a Phase 3 clinical trial for solriamfetol as a potential treatment for major depressive disorder.

Axsome Therapeutics updated its corporate presentation, showcasing its pipeline of CNS-focused therapies and upcoming clinical and regulatory milestones.

Axsome Therapeutics announced significant revenue growth for 2023, driven by its commercial products Auvelity and Sunosi, and provided updates on its clinical pipeline.