Precigen Inc. (NASDAQ: PGEN) reported that first quarter 2026 revenue is expected to exceed $18 million, driven by uptake of its respiratory disease treatment PAPZIMEOS since its launch in August 2025.

The biopharmaceutical company recorded $3.4 million in net product sales of PAPZIMEOS during the fourth quarter of 2025, with shipments beginning in November. Patient hub enrollment surpassed 300 patients in the fourth quarter.

The Centers for Medicare & Medicaid Services assigned J-code J3404 to the therapy effective April 1, 2026, which will streamline reimbursement processes.

PAPZIMEOS received full FDA approval in August 2025 for treating adults with recurrent respiratory papillomatosis (RRP), a rare disease affecting approximately 27,000 active adult cases in the United States. The treatment uses a modified adenovirus to target HPV proteins that cause the condition.

A consensus paper published in The Laryngoscope by 16 physicians recommended PAPZIMEOS as the standard-of-care first-line treatment for adults with RRP, representing a shift from surgical intervention.

Precigen plans to launch a pediatric RRP trial in the fourth quarter of 2026 and is conducting a study on patient redosing. The company filed with the European Medicines Agency in November 2025 for European approval, with the application currently under review.

RRP causes benign tumors called papillomas to grow in the respiratory tract, typically requiring multiple surgeries annually for removal. The condition affects both children and adults, with symptoms including voice hoarseness, difficulty swallowing, and breathing problems.