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Genprex Increases Shares After Reqorsa Fast-Track Appointment With Keytruda

By Robb M. Stewart

 

Shares of Genprex Inc. climbed early Monday after receiving a second fast-track designation from the Food and Drug Administration for its lead drug candidate.

In pre-market trading, the stock was up 8.4% after closing last week at $ 1.31, down 68% in the past 12 months.

Genprex has stated that the FDA has granted accelerated designation to its Reqorsa immunogenic therapy, in combination with Keytruda from Merck & Co., in patients with histologically confirmed stage III or IV non-small cell lung cancer whose the disease progressed after treatment with Keytruda.

The company said it plans to begin its Acclaim-2 clinical trial in the first quarter of 2022. The trial is an open-label, phase 1/2, multicenter clinical trial evaluating Reqorsa in combination with Keytruda.

Genprex received its first accelerated designation for Reqorsa in combination with Tagrisso from AstraZeneca PLC in patients with histologically confirmed unresectable stage III or IV NSCLC with EGFR mutations that progressed after treatment with Tagrisso .

The FDA may grant an expedited designation to drug candidates if it determines that, via non-clinical or clinical data, they demonstrate the potential to meet an unmet medical need for a serious or life-threatening illness or condition. Companies that receive the expedited designation may apply for expedited approval or continued review of an organic product license application, if other qualification criteria are met. Accelerated product candidates may also be eligible for priority review if they are supported by clinical data at the time of submitting the biologics license application.

 

Write to Robb M. Stewart at [email protected]

 

(END) Dow Jones Newswires

January 03, 2022 08:44 ET (13:44 GMT)

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