Pomerantz LLP announces that a class action lawsuit has been filed against Athenex, Inc. and certain of its officers. The class action, filed in the United States District Court for the Western District of New York, and docketed under 21-cv-00413, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquire Athenex common stock between August 7, 2019 and February 26, 2021, inclusive (the “Class Period”). This action is brought on behalf of the Class for violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”), 15 U.S.C. §§ 78j(b) and 78t(a) and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission, 17 C.F.R. § 240.10b-5.
If you are a shareholder who purchased Athenex securities during the Class Period, you have until May 3, 2021 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at email@example.com or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
Athenex is a “global clinical stage biopharmaceutical company dedicated to becoming a leader in the discovery, development, and commercialization of next generation drugs for the treatment of cancer.” Athenex is “organized around three platforms, including an Oncology Innovation Platform, a Commercial Platform, and a Global Supply Chain Platform.” One of the Company’s main drug candidates is an oral paclitaxel and encequidar for the treatment of metastatic breast cancer.
On August 7, 2019, Athenex announced topline data showing that oral paclitaxel and encequidar met the primary efficacy endpoint with statistically significant improvement over IV paclitaxel in a Phase 3 pivotal study in metastatic breast cancer. In this release, the Company stated that it intended to seek a pre-New Drug Application (“NDA”) meeting with the U.S. Food and Drug Administration (“FDA”) and would “be preparing our NDA submission as soon as possible.” Over the next several months, Defendants continued to laud their Phase 3 study of oral paclitaxel plus encequidar.
On September 1, 2020, the Company announced that the FDA had accepted for filing Athenex’s NDA for Oral Paclitaxel and Encequidar in metastatic breast cancer with priority review. In this release, Athenex announced that the FDA had set a target action date of February 28, 2021 for the Company’s NDA, and that “the FDA has communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.”
Then, on December 9, 2020, Athenex announced that it had presented updated Phase 3 data on survival and tolerability associated with Oral Paclitaxel and Encequidar in patients with metastatic breast cancer. The Company announced that it had presented this Phase 3 data at the 2020 San Antonio Breast Cancer Symposium, and that the data “demonstrat[ed] clinical benefits in efficacy and tolerability of oral paclitaxel versus IVP in patents with metastatic breast cancer . . . . The findings further support the superiority of increased ORR [objective response rate] observed with oral paclitaxel.”
The complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business. Specifically, Defendants made false and/or misleading statements and/or failed to disclose: (i) the data included in the Oral Paclitaxel plus Encequidar NDA presented a safety risk to patients in terms of an increase in neutropenia-related sequalae; (ii) the uncertainty over the results of the primary endpoint of objective response rate (ORR) at week 19 conducted by BICR; (iii) the BICR reconciliation and re-read process may have introduced unmeasured bias and influence on the BICR; (iv) that the Company’s Phase 3 study that was used to file the NDA was inadequate and not well-conducted in a patient population with metastatic breast cancer representative of the U.S. population, such that the FDA would recommend a new such clinical trial; (v) as a result, it was foreseeable that the FDA would not approve the Company’s NDA in its current form; and (vi) as a result, the Company’s public statements were materially false and misleading at all relevant times.
Before the markets opened on March 1, 2021, Athenex issued a press release entitled “Athenex Receives FDA Complete Response Letter for Oral Paclitaxel Plus Encequidar for the Treatment of Metastatic Breast Cancer.” In this release, Athenex noted that the “FDA Issues a CRL to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form.” This release further provided that “[i]n the CRL, the FDA indicated its concern of safety risk to patients in terms of an increase in neutropenia-related sequalae on the Oral Paclitaxel arm compared with the IV paclitaxel arm.”
In this March 1, 2021 press release, Athenex further stated that the “FDA 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 centra review (BICR). The [FDA] stated that the BICR reconciliation and re-read process may have introduced unmeasured bias and influence on the BICR.”
Last, in this release, Athenex wrote that the FDA “recommended that Athenex conduct a new adequate and well-conducted clinical trial in a patient population with metastatic breast cancer representative of the population of the U.S. The [FDA] determined that additional risk mitigation strategies to improve toxicity, which may involve dose optimization and / or exclusion of patients deemed to be at a higher risk of toxicity, are required to support potential approval of the NDA.”
On this news, the price of Athenex’s shares plummeted from their February 26, 2021 closing price of $12.10 per share to a March 1, 2021 close of just $5.46 each. This represents a one-day drop of approximately 55%, representing hundreds of millions of dollars in lost market capitalization.
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