ATNX - U.K's regulatory agency validates Athenex's marketing application for Oral Paclitaxel for review

Athenex (NASDAQ:ATNX) announces that its Marketing Authorization Application (MAA) for oral paclitaxel and encequidar (Oral Paclitaxel) for the treatment of advanced breast cancer has been validated by the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) for review. Shares up 4.4% premarket at $1.89. The application qualifies for a 150 day assessment by which a decision on approvability of the product will be provided. A single pivotal Phase III study of Oral Paclitaxel (KX-ORAX-001) in breast cancer served as the basis of the MAA. The study successfully achieved its primary endpoint showing statistically significant improvement in overall response rate, along with a lower incidence of neuropathy, for Oral Paclitaxel compared to IV paclitaxel.

For further details see:

U.K's regulatory agency validates Athenex's marketing application for Oral Paclitaxel for review