FDA Approves Inovio DNA Therapy After 27% Went a Year Without Surgery

The US Food and Drug Administration has granted accelerated approval to Voceryq, a plasmid DNA-based immunotherapy from Inovio Pharmaceuticals, for adults with recurrent respiratory papillomatosis (RRP). The FDA said on Oct 30, 2026, that it is the first approval of its kind in the US. Inovio is based in Plymouth Meeting, Pennsylvania.

What happened

RRP is a rare, chronic disease. Wart-like growths caused by HPV types 6 and/or 11 form in the airways, and patients often need repeated surgery to remove them. Inovio said the label covers reducing how often adults with RRP need surgery to cut out these growths.

The decision rests on Inovio's RRP-001 trial, an open-label study with no control group. It enrolled 32 adults who had needed two or more surgeries in the prior 12 months. Treatment was given over nine weeks after standard surgery to clear visible growths.

• Main result: the FDA said 7 of 26 patients (27%) with at least three surgeries in the year before treatment needed no surgery in the first year after it.
• How it works: the product delivers two plasmids. One carries HPV proteins and the other carries IL-12, an immune signalling protein. It is injected into muscle with Inovio's CELLECTRA 5PSP electroporation device.
• Side effects: the FDA listed injection site reactions, headache, fatigue, high blood pressure, nausea and dizziness as the most common.

Why it matters

Inovio called Voceryq the first FDA-approved DNA medicine and said the approval validates its platform. It estimates at least 25,000 people in the US have RRP.

It is not the only immunotherapy cleared for this disease. HCPLive noted that the FDA approved Papzimeos, an adenoviral vector-based immunotherapy for adults with RRP, a little over a year earlier.

Accelerated approval comes with conditions. The FDA said Inovio must run post-approval trials to confirm the clinical benefit. Inovio said it must send the FDA a draft protocol by the end of 2026 and expects to agree on a final protocol by mid-2027.

What it means for people in the industry

Inovio said it expects Voceryq to be available to order and ship in about 60 days, with full field deployment in the first quarter of 2027. It has engaged Syneos Health for its field teams. Medical and commercial field roles tied to the launch are the things to watch. The confirmatory study will also shape how long the approval holds.

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Sources

• FDA Approves First Plasmid DNA-based Immunotherapy for Adults with Recurrent Respiratory Papillomatosis, US Food and Drug Administration
• INOVIO Announces FDA Accelerated Approval of VOCERYQ™, an Immunotherapy to Reduce the Frequency of Surgery in Adults with Recurrent Respiratory Papillomatosis (RRP), Inovio Pharmaceuticals (PR Newswire)
• Voceryq Gains FDA Accelerated Approval for Recurrent Respiratory Papillomatosis, HCPLive