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.
Block & Leviton LLP has filed a class action lawsuit on behalf of shareholders against Athenex and certain of its executives for securities fraud. The lawsuit was filed in the U.S. District Court for the Western District of New York, located at 2 Niagara Square, Buffalo, NY 14202. The case is captioned Gupta v. Athenex, Inc., et al., No. 1:21-cv-00337 (W.D.N.Y.), and has not yet been assigned to a specific judge.