Axsome Therapeutics issued a press release this morning with the good news that lead drug candidate AXS-05 for MDD (major depression disorder) has received Priority Review from the FDA, with a PDUFA date of 8-22-21. The Priority Review is an FDA six month review to determine whether or not to approve a drug, versus a ten month standard review. Statistically, this gives the chance of approval a higher probability then if the company received a standard ten month review timeline. This also lifts the risk the stock has been under lately, as investors have ruled out the scenario of RTF (refuse to file), and standard review from the FDA. If the drug is approved by August, then I would expect the company to start commercialization with a salesforce, and sales occurring in the fourth quarter of this year. Just a reminder, the patent for AXS-05 extends out to 2034 at the very earliest, and potentially up to 2040. So at the minimum, the company will have thirteen years of exclusivity. Below is a daily chart of Axsome. The stock had a good day today up +11% under strong volume, but I expect more appreciation for the stock over the next few weeks. Thank you for reading.
