Precigen presents long-term data demonstrating durable responses to PAPZIMEOS

Precigen (PGEN) announced long-term follow-up data demonstrating durable responses to PAPZIMEOS for the treatment of adults with recurrent respiratory papillomatosis. These data were presented at the American Academy of Otolaryngology-Head and Neck Surgery Foundation 2025 Annual Meeting. PAPZIMEOS was granted full approval by the United States FDA in August 2025, becoming the first and only approved therapy for the treatment of adults with RRP. PAPZIMEOS approval was supported by results from the pivotal study, which successfully met its primary safety and pre-specified primary efficacy endpoints. PAPZIMEOS was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2. 51% of study patients achieved complete response, requiring no surgeries in the 12-month period after treatment with PAPZIMEOS. Results from the pivotal clinical study of PAPZIMEOS were published in The Lancet Respiratory Medicine.