The U.S. Food and Drug Administration (FDA) granted full and rapid approval to Precigen Inc.'s gene therapy Papzimeos (zopapogene imadenovec) for treating adults with recurrent respiratory papillomatosis (RRP), a rare condition characterized by benign tumors in the respiratory tract caused by chronic HPV infections. The priority BLA was approved ahead of its scheduled PDUFA date without an advisory committee meeting, highlighting the FDA's willingness to approve therapies based on compelling study data even without randomized trials. The therapy is expected to significantly impact the small patient population and generate increasing sales in the coming years.