Precigen (NASDAQ:PGEN), a biopharmaceutical company specializing in the development of gene and cell therapies, has announced a significant acceleration in the commercial rollout of PAPZIMEOS™ (zopapogene imadenovec-drba), projecting first-quarter 2026 revenue to exceed $18 million.
The updated guidance follows the successful assignment of a permanent Healthcare Common Procedure Coding System (HCPCS) J-code by the Centers for Medicare & Medicaid Services (CMS).
The new code, J3404, became effective April 1, 2026, and is expected to streamline the reimbursement process for providers administering the therapy in outpatient settings.
PAPZIMEOS, the first gene therapy approved for the treatment of recurrent respiratory papillomatosis (RRP), has seen "robust uptake" since its initial U.S. Food and Drug Administration (FDA) approval in August 2025.
The company reported net product sales of $3.4 million for the fourth quarter of 2025, with momentum carrying into the new year.
Enrollment in the company’s dedicated patient support hub has already surpassed 300 individuals, reflecting high demand within the RRP community.
On the regulatory front, Precigen confirmed that its Marketing Authorization Application (MAA) has been validated by the European Medicines Agency (EMA), marking the start of the formal review process in the European Union.
To further expand the therapy's addressable market, the company plans to initiate a pediatric clinical trial in the fourth quarter of 2026 and is preparing a study to evaluate patient redosing protocols.
RRP is a rare and debilitating disease characterized by the growth of tumors in the respiratory tract, often requiring repeated surgical interventions.