What happened Shares of Axsome Therapeutics (NASDAQ: AXSM) are down more than 10% in late-afternoon trading after the Food and Drug Administration (FDA) pulled the breakthrough therapy designation of its AXS-12 drug. So what The drug -- designed to treat cataplexy, the sudden loss of muscle control in narcolepsy patients -- was originally granted the designation in August of last year. The label allows for the expedited review of a promising new medicine. The decision to rescind it was due to the approval of another drug from Harmony Biosciences (NASDAQ: HRMY) for the same condition. Image source: Getty Images. Now what Management said the action doesn't change any timelines associated with the drug. The breakthrough designation was specifically for cataplexy as a condition. AXS-12 already has orphan drug designation for the treatment of narcolepsy. The company plans to initiate a randomized, double-blind, placebo-controlled, parallel-group phase 3 study in the third quarter. Shareholders will now look to August 22, the action date set by the FDA for a decision on AXS-05. That ruling will determine if the drug can be used to treat major depressive disorder. The company is also enrolling patients to determine its effectiveness in treating Alzheimer's-related agitation and for smoking cessation. 10 stocks we like better than Axsome TherapeuticsWhen our award-winning analyst team has a stock tip, it can pay to listen. After all, the newsletter they have run for over a decade, Motley Fool Stock Advisor, has tripled the market.* They just revealed what they believe are the ten best stocks for investors to buy right now... and Axsome Therapeutics wasn't one of them! That's right -- they think these 10 stocks are even better buys. See the 10 stocks *Stock Advisor returns as of June 7, 2021 Jason Hawthorne has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.Source