February 4, 2023

(GNPX), Astrazeneca PLC (NYSE:AZN) – 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 (NASDAQ: GNPX) lead drug candidate, Reqorsa Immunogene combination therapy.

  • The designation covers Reqorsa combined with Merck & Co Inc’s (NYSE: 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 (NASDAQ: 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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