Genprex Shares Rise 13% After FDA Accepts Reqorsa Name for Cancer Treatment
October 29 2020 - 2:09PM
Dow Jones News
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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