Shares of Athenex (NASDAQ:ATNX) stock are getting crushed to start the day on Monday after unfortunate news from the U.S. Food and Drug Administration (FDA).
The biopharmaceutical firm learned that the FDA issued a complete response letter (CRL) for Athenex’s New Drug Application (NDA) for oral paclitaxel plus encequidar, which is the firm’s metastatic breast cancer treatment. The FDA only delivers these notices only if a product is not ready for approval.
Overall, the issue the FDA found was its safety concern regarding “neutropenia-related sequelae on the Oral Paclitaxel arm compared with the IV paclitaxel arm.” The FDA also expressed concerns with results of a primary endpoint of the clinical trial.
In turn, the FDA recommended that Athenex start another clinical trial with “a patient population with metastatic breast cancer representative of the population in the U.S.” This is because the government agency is looking for specific strategies required for the NDA to be approved.
Dr. Rudolf Kwan, chief medical officer of Athenex, had this to say regarding the ATNX stock news:
Our clinical and regulatory teams are disappointed by the complete response letter. We plan to work with the Agency to resolve the issues raised in the CRL and to obtain approval for oral paclitaxel plus encequidar in metastatic breast cancer.
“We remain committed to the breast cancer community and will explore the best path forward to obtain regulatory approval,” Athenex CEO Dr. Johnson Lau added. “In the interim, we will identify and undertake the appropriate internal organizational adjustments accordingly.”
ATNX stock was down more than 51% as of Monday morning.
On the date of publication, Nick Clarkson did not have (either directly or indirectly) any positions in the securities mentioned in this article.
Nick Clarkson is a web editor at InvestorPlace.