Precigen is a clinical-stage biopharmaceutical company that recently became commercial following the August 2025 FDA approval of Papzimeos, an immunotherapy for recurrent respiratory papillomatosis (RRP), a rare HPV-driven disease that causes benign tumors in the respiratory tract and forces patients into repeated surgeries throughout their lifetime. Papzimeos trains the immune system to attack HPV 6 and 11 proteins — targeting the root cause of the disease rather than its symptoms. The drug is administered via subcutaneous injection over a 12-week course and requires no special device or training. Precigen estimates roughly 27,000 adult RRP patients in the U.S. and sells Papzimeos through a specialty channel, with Eversana managing sales, patient services, and distribution. Precigen manufactures drug substance at its own facility in Germantown, Maryland. Revenue is driven by patient penetration, conversion rates through payer authorization, and the potential for redosing in partial responders. Precigen is also pursuing European approval via a submitted EMA marketing authorization application. Beyond Papzimeos, the pipeline includes PRGN-2009, an investigational immunotherapy targeting HPV 16/18-associated cancers in Phase 2 trials with the National Cancer Institute, and PRGN-3006, an investigational CAR-T therapy for relapsed/refractory AML for which Precigen is seeking a development partner. Both Papzimeos and PRGN-2009 are built on Precigen's AdenoVerse platform, which uses engineered gorilla adenoviruses as delivery vehicles.