The U.S. Food and Drug Administration granted full and expedited approval to Precigen Inc.’s gene therapy Papzimeos for adults with recurrent respiratory papillomatosis (RRP), a rare chronic condition characterized by benign tumors in the respiratory tract caused by HPV 6 or 11. The approval notably bypassed the need for randomized confirmatory trials, reflecting the FDA’s flexible regulatory stance for therapies targeting very rare diseases. Analyst forecasts project growing sales, with peak revenue estimated to reach over $1 billion by 2033. The market responded vigorously, with Precigen’s shares surging following the announcement.