NEW YORK–(BUSINESS WIRE)–Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, announces that a class action lawsuit has been filed in the United States District Court for the Western District of New York on behalf of investors that purchased Athenex, Inc. (NASDAQ: ATNX) common stock between August 7, 2019 and 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.
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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, to close at $5.46 per share.
The complaint, filed on March 3, 2021, 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 that: (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 recommended 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.
If you purchased Athenex common stock during the Class Period and suffered a loss, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker, Melissa Fortunato, or Marion Passmore by email at email@example.com, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
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Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York, California, and South Carolina. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.