SAN FRANCISCO, April 19, 2021 (GLOBE NEWSWIRE) – Hagens Berman calls on Athenex, Inc. (NASDAQ: ATNX) Investors with significant losses can file their losses now.
Class Action Lawsuit Against Securities Of Athenex, Inc. (NASDAQ: ATNX):
The complaint alleges that throughout the classroom, defendants made false statements and omissions about their flagship drug candidate, an oral paclitaxel and encequidar for the treatment of metastatic breast cancer.
In particular, Defendants have misrepresented and withheld the following: (i) The data contained in the Oral Paclitaxel plus Encequidar New Drug Application presented a patient safety risk; (ii) there was uncertainty about the results of the objective response rate (ORR) primary endpoint, which may have resulted in unmeasured bias and unmeasured impact 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.
The market learned the truth on March 1, 2021 when Athenex announced it had received the FDA’s Full Response Letter (“CRL”) to the NDA for Oral Paclitaxel Plus Encequidar. In the CRL, the FDA cited patient safety risks in relation to an increase in neutropenia-related sequelae. The CRL also cited uncertainty about the results of the ORR primary endpoint at week 19, which may have resulted in an unmeasured bias and impact on the BICR. The FDA also recommended that “Athenex conduct a new adequate and well-performed clinical trial in a patient population with metastatic breast cancer representative of the US population”.
In the news, Athenex shares fell roughly 55% in one day.
“We’re focusing on investor losses and proving that Athenex has deliberately misled investors about its leading drug candidate,” said Reed Kathrein, the Hagens Berman partner who led the investigation.
If you are an Athenex investor and you are experiencing significant losses or have knowledge that may aid the company’s investigation, click here to discuss your legal rights with Hagens Berman.
Whistleblower: Individuals with nonpublic information about Athenex should consider their options to help with the investigation or to use the SEC’s whistleblower program. Under the new program, whistleblowers who provide original information can receive rewards of up to 30 percent for each successful SEC recovery. Further information is available from Reed Kathrein at 844-916-0895 or send an email to [email protected]
About Hagens Berman
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Reed Kathrein, 844-916-0895