The U.S. Food and Drug Administration has granted a rapid, full approval to Precigen Inc.'s gene therapy Papzimeos for recurrent respiratory papillomatosis (RRP), a rare disease causing benign tumors in the respiratory tract. This approval, finalized two weeks ahead of schedule and without the need for a randomized confirmatory trial, emphasizes FDA's flexible approach for therapies targeting small patient populations. Financial analysts anticipate significant sales growth for Papzimeos, marking a key milestone for Precigen and a first FDA-approved treatment for RRP.