SAN FRANCISCO, March 2, 2021 /PRNewswire/ -- Hagens Berman urges Athenex, Inc. (NASDAQ: ATNX) investors with significant losses to submit your losses now. The firm is investigating possible securities law violations and certain investors may have valuable claims.
The investigation centers on the accuracy of Athenex's disclosures about clinical trials and safety and efficacy data within the new drug application ("NDA") for the company's Oraxol, a drug intended to treat metastatic breast cancer.
In past quarters, the company emphasized the positive feedback it had received from the FDA on the Phase III clinical trials for Oraxol, "which provides further validation of our regulatory pathway for Oraxol."
Then, on Mar. 1, 2021, Athenex announced it received the FDA's complete response letter ("CRL") to the NDA. According to the company, the FDA indicated the NDA for the proposed drug is not ready for approval in its present form and recommended the company "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."
Moreover, the FDA raised concerns about safety risks to patients and the uncertainty over the results of the primary endpoint of objective response rate conducted by blinded independent central review.
This news sent the price of Athenex shares sharply lower.
"We're focused on investors' losses and whether Athenex may have intentionally misled investors about communications with the FDA concerning Oraxol," said Reed Kathrein, the Hagens Berman partner leading the investigation.
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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