Genprex's Lead Cancer Program Scores Second FDA Fast Track Tag For Lung Cancer Setting


The FDA has granted Fast Track Designation for Genprex Inc's GNPX lead drug candidate, Reqorsa Immunogene combination therapy.

  • The designation covers Reqorsa combined with Merck & Co Inc's MRK Keytruda for unresectable stage III or IV non-small cell lung cancer (NSCLC) whose disease progressed after treatment with Keytruda. 
  • Also See: Benzinga's Full FDA Calendar.
  • In Q1 of 2022, Genprex expects to initiate its Acclaim-2 clinical trial, evaluating Reqorsa in combination with Keytruda, for this patient population. 
  • The Company previously received its first Fast Track tag for Reqorsa combined with AstraZeneca Plc's AZN Tagrisso in unresectable stage III or IV NSCLC, with EGFR mutations that progressed after treatment with Tagrisso.
  • Price Action: GNPX shares are up 18.3% at $1.55 during the premarket session on the last check Monday.
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