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StocksMediumUpdated×3•Originally published 30 October 2026•Updated 30 October 2026•
4 min read

FDA Grants Accelerated Approval to VOCERYQ After 78% Reduction in Annual Surgeries in Year Two

Key Facts

1The FDA granted accelerated approval on October 30, 2026, the first U.S. approval for a plasmid DNA-based immunotherapy.
2The annual average number of surgeries fell 78%, from 4.1 before treatment among 32 participants to 0.9 in the second year among 28 participants.
37 out of 26 patients in the efficacy group required no surgical excision during 12 months.
4The company expects the treatment to be available for orders and shipping in about 60 days, with a full commercial launch in the first quarter of 2027.

The U.S. Food and Drug Administration on October 30, 2026, granted accelerated approval to VOCERYQ to treat adults with recurrent respiratory papillomatosis, marking the first U.S. approval of a plasmid DNA-based immunotherapy. The decision is based on a reduction in the frequency of surgeries, an intermediate clinical endpoint the agency considers likely to predict clinical benefit. INOVIO data show that the annual average number of surgeries fell 78% in the second year after treatment compared with the prior year. The approval comes as patients with the disorder require repeated procedures to remove growths in the respiratory tract. It is contingent on additional evidence, as the company must conduct a post-approval trial to verify and describe the clinical benefit.

The open-label, multicenter trial included 32 adults, according to the FDA. In the efficacy group, which included patients who had undergone three or more surgeries before treatment, 7 out of 26 required no surgical excision during 12 months, achieving a complete response, according to INOVIO’s announcement. This result differs from the annual average number of surgeries the company reported for the second year, both in the measurement period and the size of the group. INOVIO compared an average of 4.1 surgeries per year before treatment among 32 participants with an average of 0.9 among 28 participants in the second year. The company said the difference represents a 78% reduction in the annual average.

The company also reported that 28% of participants, or 9 out of 32, did not require surgery during the first year after treatment. The share rose to 50%, or 14 out of 28, in the second year, according to INOVIO’s disclosure. These figures measure whether surgery was needed during a defined period, while the 78% figure compares the average number of procedures per year between baseline and the second year. The results are based on groups of different sizes across periods, as the second-year group fell from 32 participants at baseline to 28 participants at the follow-up measurement. They therefore present multiple indicators of surgical frequency and response in the trial, which assessed the treatment’s safety and efficacy.

Recurrent respiratory papillomatosis is associated with human papillomavirus types 6 and 11 and causes wart-like growths in the respiratory tract. The growths can cause hoarseness, chronic cough and voice changes, and may lead to breathing difficulties in severe cases, according to the FDA. The condition requires surgical removal of the growths, making a reduction in the frequency of procedures central to the endpoint underlying the approval. VOCERYQ is an immunotherapy for adults with the disease, and the first plasmid DNA-based immunotherapy to receive U.S. approval for this use. It follows the FDA’s approval of PAPZIMEOS on August 14, 2025, to treat adults with the disease.

The FDA listed injection-site reactions, headache, fatigue, high blood pressure, nausea and dizziness among the most commonly reported side effects. The accelerated approval requires INOVIO to conduct a post-approval clinical trial to verify and describe the benefit. The company said a draft protocol for the confirmatory trial is due by the end of 2026 and that it expects to agree on a final protocol by mid-2027. The trial is the next step requested by the agency to complete verification of clinical benefit after authorization. The pathway combines access to the treatment under the current approval with continued clinical evaluation after its launch.

INOVIO expects VOCERYQ to be available for orders and shipping about 60 days after the approval announcement on October 30, 2026, with a full commercial launch in the first quarter of 2027. This timeline places initial availability ahead of the expected full commercial launch, without changing the requirement to conduct the confirmatory trial. The company also announced that a conference call on the approval is scheduled for Monday, November 2, 2026, at 8:00 a.m. Eastern time. The call will give the company an opportunity to present details of the approval and launch plans following the FDA announcement. The next regulatory step remains tied to submission of the draft confirmatory protocol at the end of 2026, followed by an expected agreement on its final version by mid-2027.