Athenex tanks as it gets CRL for its breast cancer combo therapy

2 March 2021

Athenex (Nasdaq: ATNX) closed down 54.9% at $5.46 on Monday after it revealed that the US Food and Drug Administration had issued a complete response letter (CRL) relating to the company’s New Drug Application (NDA) for oral paclitaxel plus encequidar for the treatment of metastatic breast cancer.

The FDA issues a CRL to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form and came as a surprise to analysts and investors.

In the CRL, the FDA indicated its concern of safety risk to patients in terms of an increase in neutropenia-related sequelae on the oral paclitaxel arm compared with the IV paclitaxel arm.

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