BUFFALO, N.Y., July 06, 2021 (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, today announced that the Company held a Type A meeting with the U.S. Food and Drug Administration (FDA) during the second quarter of 2021 to discuss the deficiencies raised in the Complete Response Letter (CRL) received in February.
BUFFALO, N.Y., Dec. 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 the presentation of updated Phase 3 PFS and OS data demonstrating clinical benefits in efficacy and tolerability of oral paclitaxel versus IVP in patients with metastatic breast cancer (MBC). The findings further support the superiority of increased ORR observed with oral paclitaxel. These data were presented today during a spotlight poster presentation at the 2020 San Antonio Breast Cancer Symposium (SABCS).
 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, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s New Drug Application (NDA) for oral paclitaxel and encequidar (Oral Paclitaxel) for the treatment of metastatic breast cancer and has granted the application Priority Review. The FDA grants Priority Review to applications for potential drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications1. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of February 28, 2021. Additionally, the FDA has communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.
Shares of Athenex, Inc. (ATNX) are currently gaining over 13% on Tuesday morning after the company announced that FDA accepted its NDA filing for oral paclitaxel and encequidar in metastatic breast cancer with priority review.