Athenex Shares Are Trading Lower After FDA Rejected Oral Paclitaxel Plus Encequidar Application In Breast Cancer

The FDA has issued a complete response letter (CRL) for Athenex Inc’s (NASDAQ: ATNX) marketing application seeking approval for oral paclitaxel plus encequidar to treat metastatic breast cancer.

• The CRL indicated concern about an increase in neutropenia-related sequelae observed on the oral paclitaxel arm compared with the IV paclitaxel arm.
• The FDA also expressed concerns regarding the uncertainty over the results of the primary endpoint of objective response rate at week 19 conducted by blinded independent central review (BICR).
• It suggested that the BICR was influenced.
• The agency recommended that the company conduct a new trial and adopt additional risk mitigation strategies to improve toxicity.
• Athenex plans to request a meeting with the FDA to discuss the agency’s response.
• Price Action: ATNX shares dropped 21% at $9.49 in the premarket before the trading halted. It will resume at 7:35 a.m. ET.