The U.S. Food and Drug Administration granted a swift and full approval to Precigen Inc.'s gene therapy, Papzimeos (zopapogene imadenovec), targeting recurrent respiratory papillomatosis (RRP). RRP is a rare and chronic condition characterized by benign tumors in the respiratory tract caused by chronic HPV 6 or 11 infections. This approval, achieved ahead of the PDUFA date and without requirement for randomized confirmatory trials, underscores the FDA's flexibility for therapies treating ultra-rare diseases. Analysts project first-year sales around $138 million, potentially rising to $1.1 billion by 2033. This marks Precigen's first FDA-approved product and the first therapy approved for RRP, estimated to affect about 1,000 new patients annually in the U.S.