What's Happening?
Precigen, a biopharmaceutical company, has announced significant progress in the commercialization of PAPZIMEOS, the first and only FDA-approved therapy for recurrent respiratory papillomatosis (RRP) in adults.
Since its approval in August 2025, PAPZIMEOS has been prescribed nationwide, with over 200 patients enrolled in its patient hub, reflecting a doubling of registrations since November. The therapy is covered by major private health plans, Medicare, and Medicaid, reaching approximately 170 million U.S. lives. The European Medicines Agency has also validated the Marketing Authorization Application for PAPZIMEOS, indicating potential global expansion. The company is actively engaging with medical centers and community practices to ensure widespread adoption.
Why It's Important?
The commercialization of PAPZIMEOS marks a significant advancement in the treatment of RRP, a rare and potentially life-threatening disease caused by chronic HPV infection. Traditionally managed through repeated surgeries, RRP poses a high burden on patients and healthcare systems. PAPZIMEOS offers a non-surgical treatment option, potentially improving patient quality of life and reducing healthcare costs. The therapy's broad insurance coverage and rapid adoption suggest a strong market demand, positioning Precigen for financial growth and operational sustainability. This development could set a new standard of care for RRP, influencing future therapeutic approaches and healthcare policies.
What's Next?
Precigen plans to continue expanding PAPZIMEOS's market presence, with ongoing efforts to increase patient enrollment and insurance coverage. The company anticipates further global expansion following the European Medicines Agency's validation. As PAPZIMEOS becomes established as a first-line treatment, Precigen aims to achieve cash-flow break-even. The company will likely focus on maintaining supply chain capabilities to meet growing demand and continue engaging with healthcare providers to promote the therapy's benefits. Future developments may include additional regulatory approvals and potential new indications for PAPZIMEOS.
