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Investing.com -- Precigen Inc (NASDAQ:PGEN) stock soared 77.3% after the biopharmaceutical company announced that the U.S. Food and Drug Administration (FDA) has approved PAPZIMEOS for treating adults with recurrent respiratory papillomatosis (RRP).
The approval marks a significant milestone as PAPZIMEOS becomes the first and only FDA-approved therapy for adult RRP patients. The FDA granted full approval for the treatment, eliminating the need for a confirmatory clinical trial despite the company’s initial submission under an accelerated approval pathway in December 2024.
PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy designed to target the root cause of RRP - human papillomavirus (HPV) types 6 and 11. The treatment is administered through four subcutaneous injections over a 12-week period.
The approval was supported by data from a pivotal study that met both safety and efficacy endpoints. In the trial, 51% of patients achieved a Complete Response, requiring no surgeries in the 12 months following treatment. Of the 18 patients who achieved Complete Response, 15 continued to show this response at the 24-month evaluation.
RRP is a rare and potentially life-threatening disease affecting the respiratory tract that has traditionally been managed through repeated surgeries. These procedures do not address the underlying cause of the disease and can lead to significant complications.
"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," said Helen Sabzevari, President and CEO of Precigen.
The company has established Papzimeos SUPPORT, a patient support program offering services including insurance navigation and financial assistance, as it begins promoting the newly approved treatment.
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