Health

FDA approves first DNA-based immunotherapy for rare airway disease that forces repeated surgeries

Washington • November 2, 2026 • By Press Pass USA

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The U.S. Food and Drug Administration granted accelerated approval on Friday, October 30, to Voceryq, the first plasmid DNA-based immunotherapy ever approved in the United States, for adults with recurrent respiratory papillomatosis — a rare disease that forces patients back into surgery again and again to keep their airways open.

Voceryq, developed by Inovio Pharmaceuticals of Plymouth Meeting, Pennsylvania, is approved to reduce the frequency of surgical papilloma excisions in adults with the disease, known as RRP. The FDA said the approval offers patients "a new therapeutic option that targets the root cause of RRP and has been shown to reduce the burden of surgical intervention."

RRP is caused by human papillomavirus types 6 and 11, the FDA said. The virus causes small, wart-like growths called papillomas to form in the airways, most often on and around the vocal cords. The growths can cause hoarseness, chronic cough and voice changes, and in severe cases can spread through the respiratory tract and make breathing difficult. Surgery to remove the growths has long been the standard of care — but the papillomas often grow back, and every operation carries a risk of permanent damage to the vocal cords, Inovio noted.

Voceryq works differently. It is a recombinant plasmid DNA-based immunotherapy that delivers two small circular pieces of DNA into the body's cells: one carrying genetic instructions for specific HPV-6 and HPV-11 proteins, and the other encoding IL-12, a molecule that strengthens the immune response. It is injected into muscle using Inovio's CELLECTRA 5PSP device, which applies brief electrical pulses to help the DNA enter cells.

The approval rests on a single open-label trial, RRP-001, in 32 adults who had needed at least two surgeries in the prior year. Of those, 26 patients had needed three or more surgeries in the previous 12 months — a median of 4.5 procedures — and formed the efficacy population. Seven of those 26 patients, or 27%, needed no surgical excision at all in the 12 months after treatment, a result the FDA accepted as a complete response.

Because the approval is accelerated, it is conditional. The FDA based it on a reduction in surgery frequency, an intermediate endpoint "reasonably likely to predict clinical benefit," and Inovio must run a confirmatory study to verify that benefit. The company must submit a draft protocol by the end of 2026, with a final protocol expected by mid-2027. Continued approval may depend on the results.

The FDA had previously granted Voceryq both Breakthrough Therapy and Orphan Drug designations. Inovio said the therapy was well tolerated in the trial, with the most common side effects — injection-site reactions, headache, fatigue, hypertension, nausea and dizziness — mostly mild and transient, and all 32 patients completed the study.

Inovio expects Voceryq to be available to order and ship in about 60 days, with a full commercial launch in the first quarter of 2027. The company held a conference call Monday morning to discuss the approval, and its shares surged after the announcement — the first approved product for a company that has spent years developing DNA medicines. Inovio estimates at least 25,000 Americans live with RRP.

For patients who have measured their lives in surgeries, the approval is a first step away from the operating room — one that still has to prove itself in the confirmatory trial ahead.

Sources: U.S. Food and Drug Administration news release (Oct 30, 2026); Inovio Pharmaceuticals press release (Oct 30, 2026); Inovio SEC Form 8-K filing (Nov 2, 2026).