Axsome Therapeutics (NASDAQ: AXSM) was featured in a recent equity research report published by Mizuho Securities USA LLC. The report reads, “AXS-05 Accepted and Granted Priority Review for Major Depressive Disorder: Axsome announced today that the FDA has accepted the company’s New Drug Application (‘NDA’) for AXS-05 for the major depressive disorder (‘MDD’) indication. Importantly, the FDA has also granted the application Priority Review status, which shortens the review time from ten months to six months and sets up a Prescription Drug User Fee Act (‘PDUFA’) target action date of August 22, 2021. The news is in-line with our expectations, but should still lead to significant relief rally in the shares as investors had been increasingly concerned about whether the application would get accepted, especially given some surprises we have seen from the FDA in recent weeks.”
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About Axsome Therapeutics, Inc.
Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for the management of central nervous system (“CNS”) disorders for which there are limited treatment options. For the many people facing unsatisfactory treatments for CNS disorders, Axsome accelerates the invention and adoption of life-changing medicines. Axsome’s core CNS product candidate portfolio includes five clinical-stage candidates, AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14. AXS-05 is being developed for major depressive disorder (“MDD”), Alzheimer’s disease (“AD”) agitation, and as a treatment for smoking cessation. AXS-07 is being developed for the acute treatment of migraine. AXS-12 is being developed for the treatment of narcolepsy. AXS-14 is being developed for fibromyalgia. AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14 are investigational drug products not approved by the FDA. For more information, please visit the company’s website at www.axsome.com. The company may occasionally disseminate material, nonpublic information on the company website.
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