Sam Boughedda

Investing.com — Genprex Inc (NASDAQ:)The shares of Gene Therapy Company saw a surge in response to the U.S. Food and Drug Administration’s Fast Track Designation being granted for their lead lung cancer drug candidate. This was combined with Merck’s Keytruda.

Genprex shares rose 68% after the announcement.

This designation can be used to treat patients suffering from stage III/IV non-small-cell lung cancer (NSCLC), whose condition has progressed following treatment with Keytruda. 

Genprex indicated that the company expects to begin its Acclaim-2 phase 1/2 clinical trial in which the drug is evaluated in conjunction with Keytruda. This will be in the fourth quarter 2022. 

Prior to receiving its fast track designation, the company received REQORSA and AstraZeneca’s Tagrisso for patients suffering from stage III or IV NSCLC.

Fast Track Designation is a way to expedite the approval of medications for severe conditions and unmet medical requirements. 

Rodney Varner was president and CEO of Genprex and commented: “This Fast Track Designation marks an important milestone in our efforts at accelerating clinical development of REQORSA. It also validates the ability of REQORSA, to address the unmet medical needs of late-stage NSCLC patient patients. 

We are well-positioned to move our Acclaim-1 clinical trials forward in 2022 with a solid balance sheet, $42 million cash at the end of third quarter 2021, and skilled clinical trial management under the direction of Chief Medical Officer Mark Berger (an industry veteran who joined Genprex in September 2020).