Precigen's PAPZIMEOS Receives FDA Approval, Revolutionizing RRP Treatment Landscape

Precigen's Major Breakthrough: PAPZIMEOS FDA Approval and Implications for RRP Treatment

Precigen, Inc. (Nasdaq: PGEN), a leader in the biopharmaceutical sector, has made headlines with their announcement of financial results for the third quarter of 2025 and substantial updates regarding their innovative therapies. Notably, the company has received full approval from the FDA for PAPZIMEOS (zopapogene imadenovec-drba), pioneering a new era in the treatment of recurrent respiratory papillomatosis (RRP) for adults.

RRP is a rare yet damaging condition primarily caused by HPV types 6 and 11, leading to wart-like growths in the respiratory tract. Historically, treatment has relied heavily on repetitive surgical interventions to manage symptoms, which often does not address the underlying cause of the disease. However, with the approval of PAPZIMEOS in August 2025, patients now have access to the first targeted therapy aimed at treating the root causes of RRP.

Exciting Developments Following Approval

Helen Sabzevari, PhD, President and CEO of Precigen, expressed optimism about this breakthrough, stating, “The approval of PAPZIMEOS marks the beginning of a new era for adults living with RRP.” This sentiment reflects the anticipation for a treatment that has demonstrated not only safety but also remarkable efficacy in clinical trials. The FDA approval was expedited, recognizing the urgent need for effective therapies in this patient population.

PAPZIMEOS is now available for providers across the United States and has begun shipping to prescribers. So far, over 100 patients have registered with the PAPZIMEOS Patient Hub, showcasing the immediate demand from both physicians and patients.

Moreover, Precigen's rapid market entrance strategy is evident as the company has successfully engaged over 90% of their targeted healthcare institutions. They have achieved significant private insurance coverage, extending to over 100 million lives, with additional availability through Medicare and Medicaid. This level of accessibility is a monumental advancement for adults suffering from RRP, providing them with options that were previously unavailable.

Long-Term Efficacy Data

The clinical results have spurred interest, as further follow-up data from pivotal trials indicates sustained treatment responses. The longest follow-ups showed a median duration of complete response lasting 36 months without the necessity for additional intervention. Remarkably, a majority of trial participants reported a notable decrease in the number of surgeries required in the years following treatment with PAPZIMEOS.

As Dr. Simon R. Best, MD, from Johns Hopkins University states, PAPZIMEOS represents a paradigm shift in management for adults battling RRP, addressing the disease’s underlying nature instead of merely alleviating symptoms. Following the drug's approval, a Marketing Authorization Application was submitted to the European Medicines Agency, indicating Precigen’s commitment to expand the reach of its innovative therapies globally.

Financial Health and Future Aspirations

In conjunction with their advancements in therapeutics, Precigen detailed their financial position, showcasing $123.6 million in cash and investments as of September 30, 2025, expected to support ongoing operations until cash flow becomes self-sustaining. This solid financial footing positions Precigen to enhance its commercialization efforts post-launch.

The company reported a substantial increase in selling and administrative expenses, driven by preparation for the commercial rollout of PAPZIMEOS. While net losses have escalated due to various non-cash items, the overarching goal remains to leverage the historic launch of PAPZIMEOS to drive sustained growth and patient access.

Conclusion

With the advent of PAPZIMEOS, a new precedent is set in the treatment of recurrent respiratory papillomatosis, providing patients with hope for effective management of their condition. As Precigen continues its innovative endeavors and explores new therapeutic avenues, the healthcare community watches with great anticipation. PAPZIMEOS not only symbolizes a new standard of care but also signifies the potential for future advancements in the management of diseases tethered to viral infections.

For more insights and the latest developments from Precigen, stay tuned as they navigate the evolving landscape of biopharmaceuticals.