BENSALEM, Pa.--(BUSINESS WIRE)--Law Offices of Howard G. Smith announces an investigation on behalf of Athenex, Inc. (“Athenex” or the “Company”) (NASDAQ: ATNX) investors concerning the Company’s possible violations of federal securities laws.
Athenex is a clinical stage biopharmaceutical company. Its main product candidate is an oral paclitaxel and encequidar for the treatment of metastatic breast cancer.
On September 1, 2020, the Company announced that the U.S. Food and Drug Administration (“FDA”) accepted Athenex’s New Drug Application (“NDA”) for oral paclitaxel and encequidar in metastatic breast cancer with priority review.
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.
If you purchased Athenex securities, have information or 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 Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020, by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to email@example.com, or visit our website at www.howardsmithlaw.com.
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