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”) (https://ibn.fm/J4gpJ).
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 (https://ibn.fm/0PN7j). The ODD grants a sponsor – in this…
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