The U.S. Food and Drug Administration (FDA) has granted a swift, full approval to Precigen Inc.'s gene therapy, Papzimeos (zopapogene imadenovec), for treating adults with recurrent respiratory papillomatosis (RRP), a rare and chronic condition characterized by benign tumors in the respiratory tract. This priority biologics license application (BLA) approval, completed ahead of the expected date and without requiring confirmatory randomized trials, underscores the unmet medical need in RRP. The therapy, using a nonreplicating adenoviral vector immunotherapy approach, is projected to generate significant sales growth over the coming years. The approval marks a first-of-its-kind gene therapy in this indication and represents a breakthrough in treatment options for approximately 1,000 new annual RRP cases in the U.S.