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Precigen Stock Soars on FDA Nod for Innovative RRP Immunotherapy
Precigen Inc (NASDAQ: PGEN) saw its stock jump 77.3% after the U.S. Food and Drug Administration (FDA) granted full approval to PAPZIMEOS. This marks a significant breakthrough in treating adults with recurrent respiratory papillomatosis (RRP), a rare and serious disease affecting the respiratory tract.
What Is PAPZIMEOS and Why It Matters
PAPZIMEOS is the first and only FDA-approved therapy for adults suffering from RRP. Unlike traditional treatments that focus on symptom management through surgery, PAPZIMEOS targets the root cause of the disease: the human papillomavirus (HPV) types 6 and 11.
This innovative treatment uses a non-replicating adenoviral vector-based immunotherapy. It is given via four subcutaneous injections spaced over 12 weeks, offering a new approach to managing this chronic condition.
Clinical Trial Success Drives Approval
The FDA’s approval was based on data from a pivotal clinical trial demonstrating both safety and effectiveness. In this study, 51% of patients achieved a Complete Response, meaning they required no surgeries for a full year after treatment. Impressively, most patients maintained this response for up to 24 months, showing lasting benefits.
Understanding Recurrent Respiratory Papillomatosis (RRP)
RRP is a rare but potentially life-threatening condition characterized by wart-like growths in the airways, caused by HPV. These growths can obstruct breathing and require frequent surgical removal. However, surgeries only treat symptoms and do not eliminate the underlying viral infection.
The approval of PAPZIMEOS offers hope for patients by directly targeting HPV, potentially reducing the need for repeated surgeries and improving quality of life.
Precigen’s Leadership on New Treatment Options
Helen Sabzevari, President and CEO of Precigen, emphasized the importance of this approval: “With the landmark FDA approval of PAPZIMEOS and broad label, all adult RRP patients are now eligible for access to the first and only approved therapy that targets the root cause of the disease.”
This milestone underscores Precigen’s commitment to advancing therapies that address unmet medical needs.
Market Impact and What’s Next
Following the FDA’s decision, Precigen’s stock price surged, reflecting investor confidence in the company’s new therapy and future growth potential. The full approval also eliminates the need for additional confirmatory trials, accelerating PAPZIMEOS’s path to market.
As this treatment becomes more widely available, it could transform the standard of care for adult RRP patients and potentially expand Precigen’s influence in the biopharmaceutical sector.
