Athenex, Inc.

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Lesley F. Portnoy, Esq.,
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It is alleged in this complaint that Athenex made misleading and false statements to the market. On March 1, 2021, Athenex announced that the FDA had issued a complete response letter for their New Drug Application for oral paclitaxel plus encequidar for the treatment of metastatic breast cancer. The FDA’s CRL cited patient safety risks, as well as uncertainty in relation to primary endpoint results for the objective response rate (“ORR”) which may have introduced bias in the blinded clinical review. It was recommended by the FDA that Athenex “conduct a new adequate and well-conducted clinical trial in a patient population with metastatic breast cancer representative of the population in the U.S.” The FDA also indicated that the toxicity would require a risk mitigation strategy for the treatment to be approved. Shares of Athenex fell by 55% in one day based on this news.