FDA Approves Inovio's Voceryq, the First DNA Medicine, for Rare Airway Disease That Forces Repeated Surgery

WASHINGTON — The United States Food and Drug Administration (FDA) has granted accelerated approval to Inovio Pharmaceuticals' Voceryq, a DNA-based immunotherapy for adults with recurrent respiratory papillomatosis (RRP), a rare disease in which wart-like growths repeatedly block the airways and force patients back into surgery again and again. Announced on 30 October 2026, the decision marks Inovio's first approved product and, according to the company, the first DNA medicine ever approved by the FDA.

Voceryq — previously known as INO-3107 — is approved to reduce the frequency of surgery in adults with RRP. It is a plasmid DNA immunotherapy designed to attack the root cause of the disease: infection with human papillomavirus types 6 and 11 (HPV-6 and HPV-11), which drive the growth of the papillomas. The therapy is given in combination with Inovio's CELLECTRA 5PSP delivery device, and the company said it expects the product to be available to order and ship within about 60 days, with a full commercial launch in the first quarter of 2027.

For patients, the promise is straightforward: fewer operations. People living with RRP can undergo dozens of surgeries over a lifetime as growths return to the vocal cords, trachea and lungs, each procedure carrying risks to breathing and voice. A treatment that stretches the time between surgeries — or removes the need for them for a year or more — would change daily life for a patient group that has long had surgery as its only real option.

Illustration: Scientists in a biotechnology laboratory working on a DNA-based immunotherapy, with vials and a DNA helix.

What Happened

On 30 October 2026, the FDA granted accelerated approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) to reduce the frequency of surgical papilloma excisions in adults with recurrent respiratory papillomatosis, Inovio announced. Reuters reported the same day that the regulator had approved the treatment for the rare respiratory condition, marking the company's first approved product, and that Inovio's shares rose sharply on the news.

The approval rests on the FDA's accelerated approval pathway, which allows a drug for a serious condition to reach patients on the basis of an intermediate measure that is reasonably likely to predict clinical benefit, with confirmatory evidence to follow. In Voceryq's case, the measure was complete response, defined as no requirement for surgical intervention in the 12 months after treatment in the efficacy population. Continued approval for the indication may be contingent on verification of clinical benefit in confirmatory studies, Inovio said.

The application was supported by an early- to mid-stage study in adults who had undergone at least two surgeries in the previous year, Reuters reported. Inovio said it must submit a draft protocol for the confirmatory study by the end of 2026, with the aim of agreeing a final protocol by mid-2027. The company also said it would host a conference call on Monday, 2 November 2026, to discuss the approval.

Voceryq had previously received both Orphan Drug and Breakthrough Therapy designations from the FDA, and the European Commission granted INO-3107 Orphan Drug designation, according to Inovio — designations reserved for treatments addressing rare and serious conditions with unmet medical need.

Background

Recurrent respiratory papillomatosis is a rare, chronic disease caused by HPV types 6 and 11. Benign tumours called papillomas grow in the respiratory tract, most often on the larynx, and can narrow the airway, hoarsen the voice and, in severe cases, threaten breathing. Because the growths tend to come back, patients typically need repeated surgical removals — sometimes many times a year — and each operation risks scarring the delicate vocal tissues it is meant to protect.

Until recently, there was no approved drug treatment that targeted the underlying cause. Surgery removed the growths but did nothing about the virus driving them. That began to change with a new generation of immunotherapies designed to train the immune system to recognise HPV antigens and attack the infected cells.

Voceryq takes a DNA-medicine approach: plasmids — small circles of DNA — encoding HPV-6 and HPV-11 antigens are delivered into the body, where they prompt an immune response against cells expressing those antigens. Inovio chief executive Jacqueline Shea told Reuters ahead of the decision that this sets Voceryq apart from Precigen's Papzimeos, an alternative treatment that uses a modified virus to trigger an immune response. Voceryq, she said, is a DNA-based immunotherapy.

The approval also validates a platform Inovio has pursued for years. DNA medicines have long promised advantages — stability, speed of design and manufacture — but none had previously crossed the FDA approval line. Inovio described Voceryq as the first US FDA-approved DNA medicine, a milestone for the field as well as for the company.

Illustration: A doctor examining a patient's throat in a clinic, representing care for people living with recurrent respiratory papillomatosis.

Why It Matters

For patients, the significance is measured in operations avoided. Repeated airway surgery is not only disruptive — time off work, anaesthesia, recovery — but cumulative: scar tissue can permanently alter the voice, and in children and adults alike, severe disease can obstruct breathing. A therapy that keeps patients surgery-free for a year, as the approval's response measure requires, would be a meaningful change in the course of the disease, even before longer-term data arrive.

For medicine more broadly, the approval opens a regulatory door. If a DNA medicine can win accelerated approval for a rare disease, the same platform could be applied to other HPV-related diseases and cancers — the area Inovio says it is focused on — and, in principle, to infectious diseases where rapid, adaptable vaccines matter. Regulators, investors and rival developers will all be watching how the confirmatory study is designed and how the product performs once it reaches clinics.

There are also limits that matter. Accelerated approval is not full approval: the benefit must still be confirmed, and the confirmatory study will determine whether Voceryq keeps its place on the market. The therapy is approved only for adults, only to reduce surgery frequency, and only with the CELLECTRA delivery device. Patients and clinicians will want to see how durable the response proves in a larger, more diverse group than the early-stage study population.

The commercial timetable is also tight. Inovio expects ordering and shipping within about 60 days of approval and full field deployment in the first quarter of 2027 — a window in which manufacturing, distribution and clinician training must all come together for a rare-disease product with a small, scattered patient population.

What Happens Next

The near-term milestones are clear. Inovio must submit a draft confirmatory-study protocol by the end of 2026 and agree a final protocol by mid-2027, while preparing the product for shipment within about 60 days and a full launch in early 2027. Its 2 November conference call is expected to give more detail on pricing, access and rollout plans.

Clinicians will be watching for real-world evidence: how many treated patients stay surgery-free beyond 12 months, how the therapy performs in patients with more aggressive disease, and whether the immune response holds up over time. Regulators in other regions, including Europe, where INO-3107 already holds orphan designation, may also move, potentially widening access beyond the United States.

Competition is another factor. With Precigen's virus-based Papzimeos already in the field, doctors and payers will compare effectiveness, convenience and cost between two very different immunotherapy approaches to the same rare disease — a comparison that could shape treatment guidelines for RRP in the coming years.

Illustration: A United States Food and Drug Administration building with a DNA helix and a medical delivery device, symbolising a new drug approval.

Note: This article provides general information about a regulatory approval and is not medical advice. Patients with recurrent respiratory papillomatosis should discuss treatment options with their own clinicians.

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FAQ

What is Voceryq?

Voceryq is Inovio's plasmid DNA-based immunotherapy, formerly called INO-3107, approved by the FDA on 30 October 2026 to reduce the frequency of surgery in adults with recurrent respiratory papillomatosis.

What disease does it treat?

Recurrent respiratory papillomatosis (RRP), a rare disease in which HPV-6 and HPV-11 cause wart-like growths in the airways that repeatedly return and usually require surgical removal.

How does Voceryq work?

It uses DNA plasmids encoding HPV-6 and HPV-11 antigens to generate an immune response against the virus-driven growths, delivered with Inovio's CELLECTRA 5PSP device. It is the first FDA-approved DNA medicine, according to Inovio.

What does accelerated approval mean?

It means the FDA approved Voceryq based on an intermediate measure — no surgery needed for 12 months after treatment — that is reasonably likely to predict clinical benefit, with continued approval contingent on a confirmatory study verifying that benefit.

When will Voceryq be available?

Inovio expects it to be available to order and ship within about 60 days of approval, with a full commercial launch in the first quarter of 2027.

Sources

• Reuters, "US FDA approves Inovio's treatment for rare throat disease; shares surge", 30 October 2026.
• Inovio Pharmaceuticals, "INOVIO Announces FDA Accelerated Approval of VOCERYQ, an Immunotherapy to Reduce the Frequency of Surgery in Adults with Recurrent Respiratory Papillomatosis (RRP)", 30 October 2026.
• US Food and Drug Administration approval of Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd), as reported by Reuters and Inovio, 30 October 2026.