Athenex Inc. Common Stock (NASDAQ: ATNX)
According to the Complaint, Athenex, Inc. 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.
The Complaint 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.