> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Precigen BLA for Respiratory Papillomatosis Therapy
- URL: https://www.fdaweb.com/precigen-bla-for-respiratory-papillomatosis-therapy/
- Published: 2025-02-25T12:00:00.000Z
- Updated: 2026-09-14T14:53:57.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5158719

FDA has accepted for priority review a Precigen BLA for PRGN-2012 (zopapogene imadenovec), an investigational adenoverse gene therapy for treating adults with recurrent respiratory papillomatosis (RRP). PRGN-2012 is designed to “elicit immune responses directed against cells infected with human papillomavirus (HPV) 6 or HPV 11,” the company says. The agency has set a user fee review action target date of 8/27.

RRP is described as a rare, difficult-to-treat, lifelong neoplastic disease of the upper and lower respiratory tracts caused by infection with HPV 6 or HPV 11 that can be fatal. While there is no cure for the disease, the current standard of care is repeated surgeries which do not address the underlying cause of disease and are associated with significant morbidity, Precigen says.

The submission is based on data from the company’s Phase 1/2 clinical study ([NCT04724980](https://c212.net/c/link/?t=0&l=en&o=4369390-1&h=3413189938&u=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT04724980&a=NCT04724980&ref=fdaweb.com)), which met its primary safety and efficacy endpoints, with more than 50% of patients seeing a “complete response” and more than 85% experiencing a “decrease in surgical interventions in the year after PRGN-2012 treatment compared to the year prior to treatment,” the company says.