Athenex, Inc. (ATNX) said its Marketing Authorization Application for oral Paclitaxel for the treatment of advanced breast cancer has been validated by the United Kingdom's Medicines and Healthcare products Regulatory Agency for review. A single pivotal phase III study of oral Paclitaxel was the basis of the Marketing Authorization Application.
The company noted that the application qualifies for a 150 day assessment by which a decision on approvability of the product will be provided.
Shares of Athenex were up 4% in pre-market trade on Monday.
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