LOS ANGELES--(BUSINESS WIRE)--Glancy Prongay & Murray LLP (“GPM”), a leading national shareholder rights law firm, announces that a class action lawsuit has been filed on behalf of investors who purchased or otherwise Athenex, Inc. (“Athenex” or the “Company”) (NASDAQ: ATNX) common stock between August 7, 2019 and February 26, 2021, inclusive (the “Class Period”). Athenex investors have until May 3, 2021 to file a lead plaintiff motion.
If you suffered a loss on your Athenex investments or would like to inquire about potentially pursuing claims to recover your loss under the federal securities laws, you can submit your contact information at https://www.glancylaw.com/cases/athenex-inc/. You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at firstname.lastname@example.org to learn more about your rights.
On March 1, 2021, before the market opened, Athenex disclosed receipt of a Complete Response Letter (“CRL”) from the FDA stating that the NDA would not be approved in its current form. According to 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 to the IV paclitaxel arm.” The Company 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) [because] the BICR reconciliation and re-read process may have introduced unmeasured bias and influence on the BICR.” As a result, the FDA had recommended that Athenex conduct additional clinical trials and employ certain risk mitigation strategies to improve toxicity.
On this news, the Company’s stock price fell $6.64, or 55%, to close at $5.46 per share on March 1, 2021, thereby injuring investors.
The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) 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; (2) the uncertainty over the results of the primary endpoint of objective response rate (ORR) at week 19 conducted by BICR; (3) the BICR reconciliation and re-read process may have introduced unmeasured bias and influence on the BICR; (4) 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; (5) as a result, it was foreseeable that the FDA would not approve the Company’s NDA in its current form; and (6) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.
If you purchased or otherwise acquired Athenex common stock during the Class Period, you may move the Court no later than May 3, 2021 to ask the Court to appoint you as lead plaintiff. To be a member of the Class you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the Class. If you wish to learn more about this action, or if you have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Charles Linehan, Esquire, of GPM, 1925 Century Park East, Suite 2100, Los Angeles California 90067 at 310-201-9150, Toll-Free at 888-773-9224, by email to email@example.com, or visit our website at www.glancylaw.com. If you inquire by email please include your mailing address, telephone number and number of shares purchased.
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