Athenex, Inc. announced that its proprietary Oral Paclitaxel formulation did not receive regulatory approval from the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) for metastatic breast cancer based solely on CMC issues. The MHRA application was not rejected based on any clinical efficacy or safety concerns expressed by the MHRA. MHRA regulations allow an applicant to request a re-examination of an opinion by an independent board which the Company plans to pursue.

The Company views the identified CMC issues as addressable.