• FDA grants orphan drug exclusivity for PAPZIMEOS for the treatment of adults with recurrent respiratory papillomatosis
  • Seven-year period of PAPZIMEOS market exclusivity is effective through August 14, 2032
  • PAPZIMEOS, the first and only FDA-approved therapy for adults with recurrent respiratory papillomatosis, is commercially available in the US

GERMANTOWN, Md., May 27, 2026 /PRNewswire/ -- Precigen, Inc. (NASDAQ:PGEN), a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has granted orphan drug exclusivity for PAPZIMEOS™ (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). PAPZIMEOS was granted full approval by the FDA in August 2025, becoming the first and only approved treatment for adults with RRP, a rare, chronic and debilitating disease. PAPZIMEOS is commercially available in the US and is being prescribed nationwide across both major medical centers and community practices, with patients spanning a range of disease severities actively receiving treatment.