On Aug. 15, 2025, Precigen announced that the US Food and Drug Administration (FDA) has approved PAPZIMEOS^™ (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP).

PAPZIMEOS is the first and only FDA-approved therapy for the treatment of adults with RRP. Precigen completed submission of the rolling Biologics License Application (BLA) in December 2024 under an accelerated approval pathway; however, the FDA has granted PAPZIMEOS full approval, which does not require a confirmatory clinical trial. 

PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of human papillomavirus (HPV) types 6 and 11 proteins—the root cause of RRP. PAPZIMEOS is delivered via four subcutaneous injections over a 12-week interval.

RRP is a rare, debilitating, and potentially life-threatening disease of the upper and lower respiratory tract caused by chronic HPV 6 or HPV 11 infection. RRP can lead to severe voice disturbance, a compromised airway, and recurrent post-obstructive pneumonias. Management of RRP has primarily consisted of repeated surgeries, which do not address the root cause of the disease and can be associated with significant morbidity as well as significant patient and health system burden.

The pivotal study was led by lead investigators, Clint T. Allen, MD, and Scott M. Norberg, DO, at the National Institutes of Health. Pivotal data were published in The Lancet Respiratory Medicine.

Precigen will begin promoting PAPZIMEOS immediately and is committed to helping patients with RRP access the therapy.