Shares of Genprex, Inc. (NASDAQ: GNPX) rose 18% in the extended trading session on Monday after skyrocketing 167.2% to close at $3.50.
The price action followed the Fast Track Designation (FTD) granted by the U.S. Food and Drug Administration (FDA) for the clinical-stage gene therapy company’s lead drug candidate, REQORSA Immunogene Therapy, in combination with Merck & Company’s (NYSE: MRK) Keytruda.
The therapy is designed to treat patients with histologically-confirmed unresectable stage III or IV non-small cell lung cancer (NSCLC) whose disease progressed after treatment with Keytruda. Previously presented preclinical data demonstrated synergies between REQORSA and Keytruda.
In the first quarter of 2022, Genprex is likely to initiate the Acclaim-2 clinical trial, an open-label, multi-center Phase 1/2 clinical trial to evaluate REQORSA combined with Keytruda.
Markedly, the FDA granted the first FTD to Genprex for REQORSA in combination with AstraZeneca’s (NASDAQ: AZN) Tagrisso for the treatment of patients with confirmed unresectable stage III or IV NSCLC, with EGFR mutations that progressed post-treatment with Tagrisso.
Genprex CEO Rodney Varner said, “We are thrilled to receive a second Fast Track Designation from the FDA for REQORSA in patients with late-stage NSCLC, this time in combination with the checkpoint inhibitor Keytruda.”
“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,” Varner added.
According to the American Cancer Society, more than 235,000 new cases of lung cancer and over 131,000 related deaths occurred in 2021 in the United States.
Wall Street’s Take
The stock has picked up a rating from one analyst in the past three months. Three weeks ago, Noble Financial analyst Robert LeBoyer reiterated a Buy rating on the stock and a price target of $3.50.
According to the new TipRanks Risk Factors tool, Genprex stock is at risk mainly from three factors: Tech and Innovation, Finance and Corporate, and Legal & Regulatory, which contribute 33%, 27%, and 17%, respectively, to the total 63 risks identified for the stock.