SAN FRANCISCO, March 2, 2021 / PRNewswire / – Hagens Berman urges Athenex, Inc. (NASDAQ: ATNX) investors with significant losses to file their losses now. The company is investigating possible violations of the Securities Act and certain investors may have valuable claims.
Investigation by Athenex, Inc. (NASDAQ: ATNX):
The investigation is focused on the accuracy of Athenex’s clinical trial, safety and efficacy data for the New Drug Use (“NDA”) for Oraxol, a drug used to treat metastatic breast cancer.
In the past few quarters, the company emphasized the positive feedback from the FDA on the Phase III clinical trials for Oraxol, “which enables further validation of our regulatory path for Oraxol”.
Then next March 1, 2021Athenex announced that it has received the FDA’s Full Letter of Response (“CRL”) to the NDA. According to the company, the FDA stated that the NDA is not yet ready for approval for the proposed drug in its current form and recommended that the company “conduct a new adequate and well-conducted clinical trial in a patient population with metastatic breast cancer who is representative of the population. ” in the USA”
In addition, the FDA raised concerns about patient safety risks and the uncertainty about the results of the primary endpoint, objective response rate, as assessed by a blinded independent central review.
This news caused the price of the Athenex share to fall significantly.
“We are focused on investor losses and whether Athenex has purposely misled investors about communicating with the FDA regarding Oraxol,” he said Reed Kathrein, the Hagens Berman partner who led the investigation.
If you are an Athenex investor and experience significant losses or have knowledge that may aid the company’s investigation, click here to discuss your legal rights with Hagens Berman.
Whistleblowers: Individuals with nonpublic information about Athenex should review their options to help with the investigation or use the SEC whistleblower program. Under the new program, whistleblowers who provide original information can receive rewards of up to 30 percent for each successful SEC recovery. Please call for more information Reed Kathrein at 844-916-0895 or by email [email protected].
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SOURCE Hagens Berman Sobol Shapiro LLP