AXS-12 Breakthrough Therapy Designation

The FDA has granted Axsome Therapeutics the Breakthrough Therapy Designation (BTD) for drug AXS-12 for the treatment of Narcolepsy. This was based off a phase 2 clinical trial completed in 2019, with results here AXS-12 Phase 2 Results. The designation allows for potentially quicker FDA approval of the drug, and increased communication from the FDA. The company is planning for phase 3 testing to begin in the fourth quarter of 2020.