NEW YORK, March 3, 2021 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Athenex, Inc. (NASDAQ: ATNX). Such investors are advised to contact Robert S. Willoughby at firstname.lastname@example.org or 888-476-6529, ext. 7980.
The investigation concerns whether Athenex and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
On March 1, 2021, Athenex issued a press release "announc[ing] that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the company's New Drug Application (NDA) for oral paclitaxel plus encequidar for the treatment of metastatic breast cancer." Athenex informed investors that "[i]n the CRL, the FDA indicated its concern of safety risk to patients in terms of an increase in neutropenia-related sequelae on the Oral Paclitaxel arm compared with the IV paclitaxel arm"; "also expressed concerns regarding the uncertainty over the results of the primary endpoint of objective response rate (ORR) at week 19 conducted by blinded independent central review (BICR)"; and "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 Agency determined that additional risk mitigation strategies to improve toxicity, which may involve dose optimization and / or exclusion of patients deemed to be at higher risk of toxicity, are required to support potential approval of the NDA."
On this news, Athenex's stock price fell $6.64 per share, or 54.88%, to close at $5.46 per share on March 1, 2021.
The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.
Robert S. Willoughby
888-476-6529 ext. 7980
SOURCE Pomerantz LLP