RTTNews | Mar 1, 2021 09:57AM EST

09:56 Monday, March 1, 2021 (RTTNews.com) - Athenex Inc.'s (ATNX) shares more than halved in value on Monday morning after the biopharmaceutical company received a completed response letter from FDA regarding its oral paclitaxel plus encequidar for the treatment of metastatic breast cancer.

ATNX is currently trading at $5.77, down $6.33 or 52.28%, on the Nasdaq.

Athenex, a biopharmaceutical company dedicated to the development of novel therapies for the treatment of cancer, announced that the FDA issued a complete response letter for the company's New Drug Application for oral paclitaxel plus encequidar for the treatment of metastatic breast cancer.

FDA sends a complete response letter to communicate it has completed its review of a new or generic drug application, and it decided that it will not approve it for marketing in its present form.

The FDA expressed concerns about safety risks associated with increase in neutropenia-related sequelae and the primary endpoint assessment conducted by the Blinded Independent Central Review.

The drug regulator recommended that Athenex conduct a new clinical trial in a patient population with metastatic breast cancer representative of the population in the U.S.

Read the original article on RTTNews ( https://www.rttnews.com/3173878/stock-alert-athenex-tanks-50-gets-complete-response-letter-from-fda-for-breast-cancer-treatment.aspx)

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