Athenex Issues Update On Oral Paclitaxel Application In Metastatic Breast Cancer

  • Athenex Inc ATNX held a Type A meeting with the FDA during the second quarter of 2021 to discuss the deficiencies raised in the Complete Response Letter (CRL) regarding application for oral paclitaxel plus encequidar to treat metastatic breast cancer.
  • At the meeting, Athenex provided additional analyses, including overall survival data on patient subgroups, to provide a more comprehensive summary of the risk/benefit assessment. 
  • Athenex is evaluating the optimal design for a new clinical study that will be presented to the FDA in the fourth quarter of 2021.
  • Price Action: ATNX shares are up 1.75% at $4.64 during the premarket session on the last check Tuesday.
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