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.”
To request access to the full report, visit https://ibn.fm/jdzll
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.
InvestorWire is the wire service that gives you more. From regional releases to global announcements presented in multiple languages, we offer the wire-grade dissemination products you’ll need to ensure that your next press release grabs the attention of your target audience and doesn’t let go. While our competitors look to nickel and dime you with hidden fees and restrictive word limits, InvestorWire keeps things transparent. We offer UNLIMITED Words on all domestic releases. While other wire services may provide a basic review of your release, InvestorWire helps you put your best foot forward with complimentary Press Release Enhancement.
With our competitors, the work is done the second your release crosses the wire. Not with InvestorWire. We include follow-up coverage of every release by leveraging the ever-expanding audiences of the 50+ brands that make up the InvestorBrandNetwork.
Get more out of your next press release with InvestorWire. It’s unlike anything you’ve seen before.
For more information, please visit https://www.InvestorWire.com
InvestorWire is part of the InvestorBrandNetwork.