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Investigation of Athenex, Inc.

Athenex, Inc. (ATNX) Misled Investors About the Efficacy of its Lead Drug Candidate and the Likelihood the FDA Would Approve its New Drug Application

On August 7, 2019, Athenex, Inc. (ATNX) 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 (the “Study”). The Company stated that it was preparing its New Drug Application (“NDA”) for submission to the Federal Drug Administration (“FDA”) and touted their Study over the next several months.

 On September 1, 2020, Athenex announced that the FDA had accepted for filing its NDA for Oral Paclitaxel and Encequidar in metastatic breast cancer with priority review with a target action date of February 28, 2021, and that “the FDA has communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.”  On December 9, 2020, Athenex announced it had presented updated Study data at the 2020 San Antonio Breast Cancer Symposium that “support the clinical rationale for oral paclitaxel as an efficacious and tolerable treatment option for people living with metastatic breast cancer.” 

Despite these positive statements, on March 1, 2021, Athenex announced that the FDA issued a CRL, which indicates that the review cycle for an application is complete and that the application is not ready for approval in its present form.  According to the Company, “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 IV paclitaxel arm,” among others.  The FDA “recommended that Athenex conduct a new adequate and well-conducted clinical trial …”  On this news, Athenex shares plummeted approximately 55% from $12.10 per share on February 26, 2021, to $5.46 per share on March 1, 2021.


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