The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the Western District of New York on behalf of those who acquired Athenex, Inc. (“Athenex” or the “Company”) (NASDAQ: ATNX) securities from August 7, 2019 through February 26, 2021, inclusive (the “Class Period”). Investors have until May 3, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
Before the markets opened on March 1, 2021, Athenex announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) for the company's New Drug Application for oral paclitaxel plus encequidar for the treatment of metastatic breast cancer. In the CRL, the FDA cited safety risks to patients and uncertainty over the results of the primary endpoint of the objective response rate (ORR) which might have introduced unmeasured bias and influence on the blinded independent central review. The FDA further recommended 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 noted that additional risk mitigation strategies to improve toxicity would be required for this cancer treatment to be approved. On this news, shares of Athenex stock fell approximately 55% in one day.
If you purchased or otherwise acquired Athenex securities, have information, or would like to learn more about these claims, please contact Thomas W. Elrod of Kirby McInerney LLP at 212-371-6600, by email at email@example.com, or by filling out this contact form, to discuss your rights or interests with respect to these matters without any cost to you.