Athenex Announces FDA Acceptance for Filing of U.S. NDA for Tirbanibulin Ointment in Actinic Keratosis
Athenex, Inc. (ATNX)
Last athenex, inc. earnings: 2/27 07:00 am
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Source: GlobeNewswire
BUFFALO, N.Y., March 09, 2020 (GLOBE NEWSWIRE) -- Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, announced today that the U.S. Food and Drug Administration (FDA) has completed its filing review and determined that the Company’s New Drug Application (NDA) for tirbanibulin ointment (formerly known as KX2-391 or KX-01 ointment) for the treatment of actinic keratosis (AK) is sufficiently complete to permit a substantive review. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of December 30, 2020. Additionally, the FDA has communicated that it is not currently planning on holding an advisory committee to discuss the application. “We are delighted by the FDA’s acceptance for filing of the NDA for tirbanibulin ointment, which was submitted in late December 2019,” said Dr. Rudolf Kwan, Chief Medical
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