PGEN News & Events

Precigen announced updated long-term follow-up data from the study of Papzimeos for the treatment of adults with recurrent respiratory papillomatosis, RRP. Updated durability of response data were presented at the 2026 American Society of Clinical Oncology, ASCO, Annual Meeting in Chicago in a presentation titled, "Zopapogene imadenovec-drba, a novel non-replicating adenoviral vector-based immunotherapy: Effects on complete and durable responses in recurrent respiratory papillomatosis pivotal trial." Key data highlights from the ASCO presentation include: 15 out of 18 complete responders, or 83%, demonstrated ongoing complete responses as of the April 30, 2026 data cutoff; Patients did not receive any additional treatments for RRP; All complete responders had at least 36 months of follow-up, with a median follow-up of 36 months and a mean follow-up of 40 months; 5 complete responders have ongoing responses beyond 4 years; Median duration of complete response has not yet been reached; and No new safety events were observed during long-term follow-up.

Precigen announced that the FDA has granted orphan drug exclusivity for papzimeos - zopapogene imadenovec-drba - for the treatment of adults with recurrent respiratory papillomatosis, or 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. Orphan drug exclusivity is granted to certain drugs and biologics approved for rare diseases or conditions that affect fewer than 200,000 people in the U.S. The orphan drug exclusivity granted by the FDA for papzimeos for the treatment of adults with RRP is effective through August 14, 2032, providing seven years of market exclusivity in the U.S. RRP is a rare, debilitating, and potentially life-threatening disease of the upper and lower respiratory tract that can lead to severe voice disturbance, compromised airways, and recurrent post-obstructive pneumonia.