Zinger Key Point:
- Plans underway to expand use to pediatrics, patient redosing and European approval
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.
An Alternative To Surgery
Image credit: Shutterstock.
PAPZIMEOS is an FDA-approved HPV-specific immunotherapy for the treatment of adults with RRP and, as reported by the company, the first-and-only approved therapy to address the root cause of RRP. RRP is a rare and debilitating disease that often requires patients to undergo multiple surgeries each year to remove benign tumors called papillomas that grow in the respiratory tract.
Leading RRP Physicians Agree With FDA
Beyond U.S. Adults: Pediatrics And Europe
With many in the U.S. embracing PAPZIMEOS as a new standard of care for RRP in adults, Precigen is now setting its sights on treating pediatric RRP patients and bringing the drug to adults in Europe.
During a conference call, Sabzevari said Precigen expects to launch a pediatric RRP trial in the fourth quarter of 2026.
The company also announced a study to evaluate the potential for redosing patients, which could increase the overall impact on patients.
In November 2025, the company filed with the European Medicines Agency (EMA) for European approval for RRP in adults. Precigen said the EMA validated the PAPZIMEOS Marketing Authorization Application and the application is under review.
Click here for more information on Precigen, Inc.
Featured image from Precigen
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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.
Instead of surgically removing the papillomas, PAPZIMEOS uses a modified adenovirus to teach the immune system to spot and attack the proteins found in HPV 6 and HPV 11, which are the main cause of RRP. PAPZIMEOS reduces the number of surgeries a patient needs and provides a more effective way of maintaining a clear airway, reports the company. Discovered and designed in Precigen’s labs using Precigen’s proprietary AdenoVerse therapeutic platform, the company says PAPZIMEOS represents a new therapeutic paradigm for RRP.
It is something the FDA seems to have agreed with, given that in August, the FDA granted full approval for PAPZIMEOS with a broad label and no requirement for a confirmatory trial for the treatment of adults with RRP. Since then, the treatment has been prescribed nationwide, with patients actively receiving treatment across the U.S.
Recently, a new expert consensus paper – sponsored by the Recurrent Respiratory Papillomatosis Foundation (RRPF) and authored by 16 leading physicians in the field of RRP – in support of the treatment was published in The Laryngoscope, one of the field’s most respected peer-reviewed journals, reports Precigen. The paper recommends PAPZIMEOS as the new standard-of-care first-line treatment for adults with RRP. Precigen said the paper represents a landmark moment for the RRP community, formalizing a shift away from surgery toward a new standard of care that treats the underlying HPV infection.
As it stands, there are about 27,000 active adult cases of RRP in the U.S. and in excess of 150,000 total worldwide, according to Precigen. RRP affects both children and adults. Symptoms include a progressive hoarseness of the voice, difficulty swallowing, chronic coughing and breathing problems. In extreme cases, the disease can be fatal if the papillomas cause severe airway obstruction to the lungs and the lungs become flooded with fluids and infection. In rare cases, RRP can malignantly transform into cancer.
Outside of PAPZIMEOS, the historical standard-of-care treatment for RRP was repeat surgeries to reduce the papillomas. As a result, lots of RRP patients required hundreds of surgeries over their lifetimes, which impacts their quality of life and, for many people, creates an economic burden. After all, the surgeries are only effective at removing bulked up papillomas in the respiratory tract, but not at preventing future buildup. What’s more, these frequent surgeries for RRP can worsen a patient’s condition over time by potentially increasing the spread of the HPV virus and the likelihood of serious co-morbidities, including breathing issues and loss of vocal function.
RRP is a rare and debilitating disease that severely impacts the quality of life for sufferers. Precigen is helping change that. With the treatment taking off in the U.S, and with expansion underway in Europe and into pediatric RRP, Precigen is giving hope to the tens of thousands of patients who have no other choice than to have recurring surgeries. To learn more about Precigen and PAPZIMEOS, click here.