The U.S. FDA has granted full and expedited approval to Precigen Inc.’s gene therapy, Papzimeos (zopapogene imadenovec), targeting recurrent respiratory papillomatosis (RRP), a rare disease marked by benign tumors in the respiratory tract caused by chronic HPV infections. The therapy, a nonreplicating adenoviral vector-based immunotherapy, received priority review and orphan drug designations. The FDA’s decision was notable for requiring no confirmatory randomized trials, reflecting the unmet medical need in RRP. Analyst projections forecast annual sales potentially reaching $1.1 billion by 2033. Precigen's stock surged significantly on the approval news, underscoring market optimism for this first-in-class treatment.