By Chris Wack

 

Genprex Inc. shares were up 13% to $3.50 after the company said the U.S. Food and Drug Administration has conditionally accepted the proprietary name Reqorsa for its lead drug candidate in development for the treatment of non-small cell lung cancer, known previously by the laboratory designation GPX-001.

Volume for the stock was two million shares at 1:30 p.m. ET, compared with its 65-day average volume of 868,000 shares.

The company said the name Reqorsa was developed in accordance with FDA's guidance for the submission and evaluation of proprietary names. The company selected the name based on comprehensive and disciplined review of name candidates, including a research study of health-care practitioners across the U.S. to ensure accurate prescription and safety interpretation of the name.

Genprex said the FDA's conditional acceptance of the proprietary name is a necessary step toward being able to market its lead drug candidate for non-small cell lung cancer.

Genprex will resubmit its proprietary name for FDA final review upon completion of all required clinical trials and prior to the submission of a Biologics License Application. Final approval of the Reqorsa brand name is conditional on FDA approval of the product candidate.

In January 2020, the FDA granted Fast Track Designation for Reqorsa in combination with AstraZeneca's Tagrisso for the treatment of non-small cell lung cancer.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

October 29, 2020 13:54 ET (17:54 GMT)

Copyright (c) 2020 Dow Jones & Company, Inc.
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