NasdaqGM:AXSMPharmaceuticals
Axsome Therapeutics (AXSM) Wins FDA Acceptance For AXS 12 In Narcolepsy
Axsome Therapeutics reported that the FDA has accepted its New Drug Application for AXS-12 for the treatment of cataplexy in narcolepsy.
The FDA does not plan to hold an advisory committee meeting as part of the review.
The filing acceptance marks a key regulatory step for AXS-12, a potential option for a serious sleep disorder with unmet medical need.
For Axsome Therapeutics (NasdaqGM:AXSM), this regulatory milestone arrives with the stock trading around $239.62 and a very large 3 year and...