The U.S. Food and Drug Administration has granted full approval to Precigen Inc.’s PAPZIMEOS (zopapogene imadenovec-drba), the first authorised therapy for adults with recurrent respiratory papillomatosis, a rare disease caused by chronic human papillomavirus types 6 and 11 infection. The decision arrives nearly two weeks before the drug’s expected action date and converts what had been an accelerated-approval filing into an immediate full licence, eliminating the need for a confirmatory study. Regulatory clearance was based on an open-label, single-arm trial in which 51 percent of the 35 treated patients achieved a complete response—defined as being surgery-free for 12 months—while 15 of 18 responders maintained that result at two years. The immunotherapy, delivered as four subcutaneous injections over 12 weeks, was well tolerated with no dose-limiting toxicities or treatment-related adverse events above Grade 2. PAPZIMEOS offers the first non-surgical option for an estimated 27,000 U.S. adults who often undergo repeated procedures to remove benign tumours that can obstruct the airway and impair speech. Precigen said it will launch the product immediately and provide financial-assistance programmes through its Papzimeos SUPPORT service. Investors welcomed the ruling; Precigen’s shares rose about 60–75 percent in pre-market trading on Friday. The approval also signals FDA openness to single-arm data for other gene and cell therapies targeting rare conditions, according to industry analysts.