FDA Grants Priority Review to Precigen’s BLA for PRGN-2012 in Recurrent Respiratory Papillomatosis
Precigen, Inc. announced that the FDA has accepted its Biologics License Application (BLA) for PRGN-2012 (zopapogene imadenovec†), an investigational AdenoVerse gene therapy for adults with recurrent respiratory papillomatosis (RRP). The FDA granted priority review, setting a target action date of August 27, 2025. No advisory committee meeting is currently planned for the application.
If approved, PRGN-2012 would become the first and only FDA-approved therapy for RRP, a rare and lifelong neoplastic disease caused by HPV 6 or HPV 11, which currently requires repeate...
