SAN FRANCISCO, April 12, 2021 (GLOBE NEWSWIRE) — Hagens Berman urges Athenex, Inc. (NASDAQ: ATNX) investors with significant losses to submit your losses now.
Athenex, Inc. (NASDAQ: ATNX) Securities Class Action:
The Complaint alleges that throughout the Class Period, Defendants made false statements and omissions about its flagship drug candidate, an oral paclitaxel and encequidar for the treatment of metastatic breast cancer.
Specifically, Defendants misrepresented and concealed that: (i) the data included in the Oral Paclitaxel plus Encequidar New Drug Application presented a safety risk to patients; (ii) there was uncertainty over the results of the primary endpoint of objective response rate (ORR), which might have introduced unmeasured bias and influence on the blinded independent central review (BICR); (iii) the Company’s Phase 3 study did not include a representative population; and (iv) as a result, it was foreseeable that the FDA would not approve the Company’s NDA in its current form.
On Mar. 1, 2021, the market learned the truth when Athenex announced it received the FDA’s complete response letter (“CRL”) to the NDA for oral paclitaxel plus encequidar. In the CRL, the FDA cited safety risks to patients in terms of an increase in neutropenia-related sequalae. The CRL also cited uncertainty over the results of the primary endpoint of the ORR at week 19, which might have introduced unmeasured bias and influence on the BICR. The FDA further 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.”
On this news, shares of Athenex stock fell approximately 55% in one day.
“We’re focused on investors’ losses and proving Athenex intentionally misled investors about its leading drug candidate,” said Reed Kathrein, the Hagens Berman partner leading the investigation.
If you are an Athenex investor and have significant losses, or have knowledge that may assist the firm’s investigation, click here to discuss your legal rights with Hagens Berman.
Whistleblowers: Persons with non-public information regarding Athenex should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email [email protected].
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Reed Kathrein, 844-916-0895