SAN DIEGO–()–Robbins Geller Rudman & Dowd LLP announces that a class action lawsuit has been filed in the Western District of New York on behalf of purchasers of Athenex, Inc. (NASDAQ:ATNX) common stock between August 7, 2019 and February 26, 2021, inclusive (the “Class Period”). The case is captioned Gupta v. Athenex, Inc., No. 21-cv-00337. The Athenex class action lawsuit charges Athenex and certain of its officers with violations of the Securities Exchange Act of 1934.

The Private Securities Litigation Reform Act of 1995 permits any investor who purchased Athenex common stock during the Class Period to seek appointment as lead plaintiff in the Athenex class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the Athenex class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the Athenex class action lawsuit. An investor’s ability to share in any potential future recovery of the Athenex class action lawsuit is not dependent upon serving as lead plaintiff. If you wish to serve as lead plaintiff of the Athenex class action lawsuit or have questions concerning your rights regarding the Athenex class action lawsuit, please provide your information here or contact counsel, J.C. Sanchez of Robbins Geller, at 800/449-4900 or 619/231-1058 or via e-mail at jsanchez@rgrdlaw.com. Lead plaintiff motions for the Athenex class action lawsuit must be filed with the court no later than May 3, 2021.

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. One of Athenex’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. Athenex also 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.”

The Athenex class action lawsuit alleges that, throughout the Class Period, 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 sequelae; (ii) the uncertainty over the results of the primary endpoint of objective response rate (“ORR”) at week 19 conducted by blinded independent central review (“BICR”); (iii) the BICR reconciliation and re-read process may have introduced unmeasured bias and influence on the BICR; (iv) Athenex’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 Athenex’s NDA in its current form; and (vi) consequently, Athenex’s public statements were materially false and misleading at all relevant times.

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,” which indicated that the FDA found that the NDA was “not ready for approval in its present form.” According to Athenex, “[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.” Athenex further stated that the “FDA also expressed concerns regarding the uncertainty over the results of the primary endpoint of [ORR] at week 19 conducted by [BICR]. The [FDA] stated that the BICR reconciliation and re-read process may have introduced unmeasured bias and influence on the BICR.” Athenex also revealed 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 in 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 higher risk of toxicity, are required to support potential approval of the NDA.” On this news, the price of Athenex’s shares fell approximately 55%, damaging investors.

Robbins Geller Rudman & Dowd LLP is one of the world’s leading law firms representing investors in securities class action litigation. With 200 lawyers in 9 offices, Robbins Geller has obtained many of the largest securities class action recoveries in history. For seven consecutive years, ISS Securities Class Action Services has ranked the Firm in its annual SCAS Top 50 Report as one of the top law firms in the world in both amount recovered for shareholders and total number of class action settlements. Robbins Geller attorneys have helped shape the securities laws and have recovered tens of billions of dollars on behalf of aggrieved victims. Beyond securing financial recoveries for defrauded investors, Robbins Geller also specializes in implementing corporate governance reforms, helping to improve the financial markets for investors worldwide. Robbins Geller attorneys are consistently recognized by courts, professional organizations, and the media as leading lawyers in the industry. Please visit http://www.rgrdlaw.com for more information.

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