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FDA rejects Athenex s oral chemotherapy, asks for another clinical trial

Athenex’s bid to offer an oral version of an intravenous chemotherapy has stalled after the FDA rejected the drug. Among the remedies proposed by the regulator is another Phase 3 study.

Athenex, Inc (ATNX) Q4 2020 Earnings Call Transcript

Operator Greetings and welcome to the Athenex, Inc. Fourth Quarter and Fiscal Year 2020 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Steve Rubis, Senior Director of Investor Relations for Athenex. Thank you. You may begin. Steven Rubis Senior Director, Investor Relations Good morning and thank you for joining our conference call. This morning, we published two press releases. The first announces that we received a complete response letter from the FDA for Oral Paclitaxel. The second announces our fourth quarter and full year 2020 financial results. These news releases crossed the wire earlier this morning and are available on our website. Today, we will provide an update on Athenex s business as well as a review of financial results for the fourth quarter and full year 2020. A replay of this call will also be archived on the company website.

Athenex Receives FDA Complete Response Letter for Oral Paclitaxel Plus Encequidar for the Treatment of Metastatic Breast Cancer

Athenex Receives FDA Complete Response Letter for Oral Paclitaxel Plus Encequidar for the Treatment of Metastatic Breast Cancer
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