Precigen Sees Strong Early Demand for New Immunotherapy Since Launch, CMS Reimbursement Code Boosts Access as Sales Expected to Top $18M

Precigen Inc. (NASDAQ:PGEN), a commercial-stage biopharmaceutical company developing precision medicines to improve the quality of life for people suffering from recurrent respiratory papillomatosis (RRP) and other diseases, is making progress on that front, announcing it has seen "robust uptake" in usage of PAPZIMEOS (zopapogene imadenovec-drba), since launching the immunotherapy in August 2025. What's more, the company announced that the Centers for Medicare & Medicaid Services (CMS) assigned J-code J3404 to the therapy effective April 1, 2026, which will streamline reimbursement and broaden access to the treatment.

"In the short time since early and full approval, the standard-of-care first-line treatment is seeing tremendous progress," said Precigen's President and CEO, Helen Sabzevari, during a conference call to discuss fourth quarter results. "This substantial advancement constitutes a pivotal milestone for all stakeholders impacted by RRP." As a result of the interest in PAPZIMEOS, Sabzevari said the company is transforming from a research and development biopharmaceutical company to a product revenue generating biotech company. Net product sales of PAPZIMEOS were $3.4 million in the fourth quarter of 2025, with shipments commencing in November. In the fourth quarter, Precigen patient hub enrollment surpassed 300, a testament to physician and patient demand.

Sabzevari noted the company expects revenue in the first quarter of 2026 to exceed $18 million given the momentum of PAPZIMEOS. "This is a clear sign of the enthusiasm we are seeing from patients and physicians alike, leading to a robust use of the immunotherapy," she said.