Skip to main content

Genprex Inc. (NASDAQ: GNPX) Celebrates Receipt of Orphan Drug Designation, Third Fast Track Designation Amid Preparations for Planned Acclaim-3 Clinical Trial

  • Genprex recently received orphan drug designation for its lead drug candidate REQORSA(R) Immunogene Therapy (quratusugene ozeplasmid) for the treatment of small cell lung cancer (“SCLC”)
  • The company also celebrated receipt of its third Fast Track Designation (“FTD”), granted by the FDA, this time for REQORSA Immunogene Therapy, in combination with Tecentriq in patients with extensive stage small cell lung cancer (“ES-SCLC”)
  • The orphan drug designation (“ODD”) in combination with the FTD is an indication of the great need for better treatment options for patients with ES-SCLC, and non-small cell lung cancer (“NSCLC”), according to Genprex President, Chairman, and CEO Rodney Varner
  • With the receipt of the latest FTD and the orphan drug status, Genprex is looking forward to initiating the Acclaim-3 clinical trial, planned for the fourth quarter of 2023

Genprex (NASDAQ: GNPX), a clinical-stage company developing life-changing gene therapies for patients with cancer and diabetes, recently celebrated an important milestone: the award of an orphan drug designation. The company announced August 10 that the United States Food and Drug Administration (“FDA”) had granted Orphan Drug Designation (“ODD”) to its lead drug candidate, REQORSA(R) Immunogene Therapy (quratusugene ozeplasmid), for the treatment of small cell lung cancer (“SCLC”) (

The FDA grants orphan drug status to a drug or biological product that prevents, diagnoses, or treats a rare disease or condition as part of the agency’s efforts to prioritize the development and evaluation of new treatments for rare diseases ( The ODD grants a sponsor – in this…

Read More>>

NOTE TO INVESTORS: The latest news and updates relating to GNPX are available in the company’s newsroom at

About BioMedWire

BioMedWire (BMW) is a bio-med news and content distribution company that provides (1) access to a network of wire services via InvestorWire to reach all target markets, industries and demographics in the most effective manner possible, (2) article and editorial syndication to 5,000+ news outlets (3), enhanced press release services to ensure maximum impact, (4) social media distribution via the Investor Brand Network (IBN) to millions of social media followers, (5) a full array of corporate communications solutions, and (6) a total news coverage solution with BMW Prime. As a multifaceted organization with an extensive team of contributing journalists and writers, BMW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. By cutting through the overload of information in today’s market, BMW brings its clients unparalleled visibility, recognition and brand awareness. BMW is where news, content and information converge.

To receive SMS text alerts from BioMedWire, text “Biotech” to 844-397-5787 (U.S. Mobile Phones Only)

For more information, please visit

Please see full terms of use and disclaimers on the BioMedWire website applicable to all content provided by BMW, wherever published or re-published:

BioMedWire (BMW)
San Francisco, California
415.949.5050 Office

BioMedWire is part of the InvestorBrandNetwork.

Data & News supplied by
Stock quotes supplied by Barchart
Quotes delayed at least 20 minutes.
By accessing this page, you agree to the following
Privacy Policy and Terms and Conditions.