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FDA Approves Inovio’s DNA-Based Therapy for Rare Throat Disease

The FDA approved Inovio's Voceryq on October 30 for recurrent respiratory papillomatosis, with a confirmatory study required under accelerated approval.

Conceptual illustration of the throat and DNA-based immunotherapy research

News event: October 30, 2026. The US Food and Drug Administration has approved Voceryq, a DNA-based immunotherapy from Inovio Pharmaceuticals, for recurrent respiratory papillomatosis, a rare condition that causes recurring growths in the throat and airways.

The decision marks Inovio’s first approved product and offers another treatment option for a disease in which patients may need repeated procedures to keep their airways clear.

What is recurrent respiratory papillomatosis?

Recurrent respiratory papillomatosis, often shortened to RRP, involves noncancerous, wart-like growths that can affect breathing and speech. It is commonly associated with human papillomavirus types 6 and 11. Although surgery can remove growths, the condition frequently returns, creating a cycle of operations and recovery.

Repeated procedures may place strain on the voice and carry risks, including damage to the vocal cords. Researchers have therefore sought treatments that help the immune system control the underlying virus and reduce the need for surgery.

How Voceryq differs from earlier treatment

Voceryq, also known as INO-3107, is designed to stimulate an immune response against the HPV types associated with RRP. Another medicine, Precigen’s Papzimeos, received US approval in 2025 and uses a different method to trigger immunity.

Inovio’s application was supported by a study of adults who had required at least two surgeries in the previous year. The FDA granted accelerated approval, which allows certain treatments for serious conditions to reach patients on the basis of earlier evidence while requiring additional confirmation of clinical benefit.

What patients and doctors should know

The company expects the medicine to become available for orders and shipments within about 60 days, with a broader launch planned for the first quarter of 2027. It must also conduct a confirmatory study and expects to advance that study’s design during 2027.

Accelerated approval should not be confused with proof that the medicine eliminates the disease or that it is appropriate for every patient. Treatment decisions require specialist assessment of symptoms, prior surgery history and the approved prescribing information.

Source: Reuters, October 30, 2026.

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