By Sam Boughedda
Investing.com — Genprex Inc (NASDAQ:GNPX), the gene therapy company, saw its shares surge on news the U.S. Food and Drug Administration has granted Fast Track Designation for its lead lung cancer drug candidate in combination with Merck's Keytruda.
Genprex stock soared 68% following the announcement.
The designation is for treating patients with stage III or IV non-small cell lung cancer (NSCLC) whose disease progressed after treatment with Keytruda.
Genprex said it expects to initiate its Acclaim-2 clinical trial, a phase 1/2 clinical trial evaluating the drug, called REQORSA, in combination with Keytruda, in the first quarter 2022.
The company previously received its first fast track designation for REQORSA combined with AstraZeneca's Tagrisso in patients with stage III or IV NSCLC, with epidermal growth factor receptor (EGFR) mutations that advanced after treatment with Tagrisso.
Fast Track Designation allows for the faster approval of drugs for serious conditions that fill an unmet medical need.
Commenting on the news, Rodney Varner, president and CEO at Genprex, said: "This Fast Track Designation is an important step in our efforts to accelerate clinical development of REQORSA and another validation of the potential of REQORSA to treat the unmet medical need of patients with late-stage NSCLC.
"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."