Genprex [NASDAQ: GNPX] Gets FDA Fast Track Designation for REQORSA

Genprex, Inc. [NASDAQ: GNPX] shares skyrocketed 110% at the time of writing on Monday. The strong performance of the company’s share has indicated the positive sentiments of the investors after the firm disclosed that it has obtained Fast Track Designation (FTD) for the Company’s lead drug candidate, REQORSA Immunogen Therapy from FDA.

FDA has provided FTD for REQORSA Immunogen Therapy in conjunction with Merck & Co’s Keytruda in sufferers with histologically-confirmed inoperable stage III or IV non-small cell lung cancer (NSCLC) whose disease continued after curing with Keytruda. The company is happy to receive a second FTD from the FDA for REQORSA in suffers from late-stage NSCLC, this time in conjunction with the checkpoint inhibitor Keytruda.

In addition, the Company earlier obtained its first FTD for REQORSA in combination with AstraZeneca PLC’s Tagrisso in sufferers with histologically confirmed inoperable stage III or IV NSCLC, with EGFR mutations that progressed following treatment with Tagrisso.

Furthermore, in Q1 of 2022, Genprex anticipates commencing its Acclaim-2 clinical trial, which is an open-label, multi-center Phase 1/2 clinical trial assessing REQORSA in conjunction with Keytruda, for this victim population. FTD offers opportunities to firm more common engagement with the FDA to talk about the drug candidate’s development plan and also offers potential eligibility for priority review, which has a six-month review timeline.