Precigen Inc. received swift full FDA approval for Papzimeos (zopapogene imadenovec), a gene therapy treating recurrent respiratory papillomatosis (RRP), characterized by benign respiratory tract tumors caused by chronic HPV infections. The nonreplicating adenoviral vector therapy had priority review and gained approval two weeks ahead of its PDUFA date without requiring confirmatory randomized trials. Analysts view this as an acknowledgment of the unmet medical need in RRP. The approval marks Precigen's first and the inaugural FDA-approved therapy for RRP, with potential significant market impact.