While vaccine stocks have attracted all the hype recently, another pharmaceutical company is in the spotlight today. Shares of Genprex (NASDAQ:GNPX) are trading higher by over 105% on the heel of some exciting news. It’s safe to say that shareholders of GNPX stock are having a phenomenal start to the new year.
Today, the U.S. Food and Drug Administration (FDA) announced that it had granted fast track designation (FTD) for REQORSA, in combination with Merck’s (NYSE:MRK) Keytruda drug. REQORSA is Genprex’s lead candidate that works to treat non-small cell lung cancer (NSCLC). The FTD is for patients “whose disease progressed after treatment with Keytruda.”
CEO and President Rodney Varner praised the FTD, adding that:
“With a strong balance sheet of $42 million in cash as of the end of the third quarter of 2021 and expert clinical trial management led by Chief Medical Officer and industry veteran Mark Berger, MD who joined Genprex in September 2021, we are well positioned to advance our Acclaim-1 and Acclaim-2 clinical trials in a meaningful way in 2022.”
So, what exactly is a fast track designation? FTD is a process granted by the FDA to “expedite the review of drugs to treat serious conditions and fill an unmet medical need.” A company must request FTD from the FDA. Once approved, the company will be able communicate freely with the FDA on any developments or issues that arise. This communication can possibly lead to faster approval times.
With the definitions covered, let’s jump right into the news sending shares of GNPX stock higher.
GNPX Stock: 5 Things to Know About Fast Track Designation
- This is the second FTD that Genprex has received for REQORSA. The first FTD covers its use in combination with AstraZeneca’s (NASDAQ:AZN) Tagrisso drug for “patients with histologically confirmed unresectable stage III or IV NSCLC, with EGFR mutations that progressed after treatment with Tagrisso.” Unresectable refers to a type of cancer that doctors cannot remove with surgery.
- According to the World Health Organization (WHO), lung cancer was the leading cause of cancer deaths worldwide. Additionally, the American Society of Clinical Oncology notes that NSCLC represents 84% of all lung cancers.
- Previous nonclinical data has shown that REQORSA combined with Keytruda was more effective than Keytruda alone. The nonclinical study was conducted on mice “with a humanized immune system that had metastatic lung cancers.”
- Furthermore, the study saw an increase in Natural Killer cells and a decrease in PD-L1 expression on tumor cells. The synergy from the two drugs is believed to have contributed toward this. Natural killer cells can kill tumor cells.
- Finally, Genprex expects to start its Phase 1 and 2 trials that evaluate REQORSA in combination with Keytruda in the first quarter of this year.
On the date of publication, Eddie Pan did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.