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0.00203804347826083 -0.00271739130434789 -0.0149456521739131 0.000339673913043531 -0.00475543478260872 -0.00849184782608696 -0.0268342391304348 -0.0336277173913043
Stock impact report

Axsome Therapeutics Announces FDA Acceptance of New Drug Application for AXS-07 for the Acute Treatment of Migraine [Financial Post (Toronto, Ontario, Canada)]

Axsome Therapeutics, Inc. (AXSM)  More Company Research Source: Financial Post
Last axsome therapeutics, inc. earnings: 3/12 07:00 am Check Earnings Report
US:NASDAQ Investor Relations: axsome.com
PDF NEW YORK, Sept. 14, 2021 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for AXS-07 for the acute treatment of migraine, and has set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2022 for the NDA. AXS-07 (MoSEIC™ meloxicam-rizatriptan) is a novel, oral, rapidly absorbed, multi-mechanistic, investigational medicine for migraine. “The FDA's acceptance of the NDA for AXS-07 is an important milestone for Axsome as it brings us closer to potentially making this multi-mechanistic treatment available to migraine patients in need,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “We look forward to continued interactions with the FDA during the review process.” The NDA is supported by results [Read more]
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