Athenex, Inc.

According to the complaint, 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 allegedly failed to disclose to investors that:

The complaint alleges that throughout the class period, the defendants made false and misleading statement and 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.