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.
About QualityStocksNewsBreaks
QualityStocksNewsBreaks provide a rapid summary of corporate news that catch the attention of QualityStocks. QualityStocksBreaks are designed to keep investors up to date on important and breaking news in the small-cap and micro-cap markets. Spanning all industries, including energy, entertainment, telecommunications, healthcare, retail and more, these news breaks deliver opportunities the investment community may have missed. Whether it is earnings results, mergers and acquisitions, or any other market-moving news, our news breaks keep you in the know. QualityStocks is committed to connecting subscribers with companies that have huge potential to succeed in the short and long-term future. It is part of our mission statement to help the investment community discover emerging companies that offer excellent growth potential.
QualityStocks (QS)
Scottsdale, Arizona
www.QualityStocks.com
480.374.1336 Office
Editor@QualityStocks.com
Please see full terms of use and disclaimers on the QualityStocks website applicable to all content provided by QS, wherever published or re-republished: http://www.qualitystocks.net/disclaimer.php
No comments:
Post a Comment