The U.S. Food and Drug Administration has granted full and rapid approval to Precigen Inc.’s gene therapy, Papzimeos (zopapogene imadenovec), addressing recurrent respiratory papillomatosis (RRP), a rare disease characterized by benign tumors in the respiratory tract caused by HPV types 6 and 11. The priority Biologics License Application (BLA) received an Aug. 27 PDUFA date but was approved two weeks early without the need for confirmatory randomized trials, highlighting regulatory flexibility for rare diseases under CBER’s direction. The approval is expected to generate $138 million in sales during its first full year, ramping to $1.1 billion by 2033. Investors responded positively as Precigen shares surged on the news.