Another positive development involving Axsome Therapeutics and drug AXS-14, for Fibromyalgia. The FDA has given the company an expedited pathway to file a New Drug Application from the already completed, and positive phase 2 and phase 3 clinical trials. The company plans to initiate the NDA process in the fourth quarter of 2022, with expected FDA approval by third quarter 2023. This adds to their pipeline of AXS-05 for MDD, and AXS-07 for Acute Migraine. Both those drugs are already going through the FDA approval process, with AXS-05 expecting an approval by August 22nd of 2021.
