The US Food and Drug Administration (FDA) has granted accelerated approval to Voceryq, a DNA-based treatment from Inovio Pharmaceuticals, to reduce how often adults with recurrent respiratory papillomatosis (RRP) need surgery, the company announced on October 30, 20261. RRP is a rare disease caused by two strains of the human papillomavirus, HPV-6 and HPV-112. Voceryq is the brand name for the product earlier known as INO-3107. Its full scientific name is doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd1.
What happened
Inovio said the FDA approved Voceryq “to reduce the frequency of surgery in adults with RRP,” and that this use was approved under the agency’s accelerated approval program1. The FDA had accepted Inovio’s application for review in December 2025 under that same program. It set October 30, 2026 as the target date for its decision2. In September, Inovio said the application was still under FDA review ahead of that date1.
Before the decision, the treatment had already received two FDA labels that can speed up development: Breakthrough Therapy designation and Orphan Drug designation, which is for rare diseases. It also has Orphan Drug designation in Europe and an Innovation Passport in the UK2.
Voceryq is described as a DNA immunotherapy. It delivers pieces of DNA meant to teach the body’s immune system to mount a response against HPV-6 and HPV-112. In the main trial, the DNA was given together with a device called CELLECTRA 20003. That device uses electroporation, a brief electrical pulse that helps the DNA get into cells.
The evidence so far
The approval rests mainly on one early-stage trial, called RRP-001. ClinicalTrials.gov lists it as a combined Phase 1/2 study, an early test that looks at safety and first signs of benefit. It ran at several centers, was sponsored by Inovio and enrolled 32 people3. It started in October 2020, finished its main data collection in December 2022, and posted results on the registry in April 20263.
The trial was “open-label,” meaning patients and doctors knew everyone was getting the treatment3. Its registered main goal was safety: the share of people who had side effects from the first dose until about 30 days after the last one, roughly up to week 133. It included people whose disease began in childhood (before age 12) and people whose disease began at 12 or older3.
According to Inovio, 72% of patients in RRP-001 had 50% to 100% fewer surgeries in the first year after starting treatment2. The company says the treatment was well tolerated. Most side effects were mild, the lowest grade, such as pain where the shot was given and tiredness2.
A follow-up study, RRP-002, looked back at records for 28 of the people from the first trial. Inovio reports that 86% of them had 50% to 100% fewer surgeries in the second year, with no extra doses. Half of those patients needed no surgery at all that year2. The company also points to immune data. Those data showed the treatment produced new groups of killer T cells, a type of immune cell, in the blood. These cells traveled to airway tissue and were linked with needing fewer surgeries2. The results were published in 2025 in the journals Nature Communications and The Laryngoscope2.
What it does not show yet
The registry record lists only the treatment and its delivery device, with no placebo (dummy treatment) group3. Without a comparison group, the trial cannot show how much of the drop in surgeries came from Voceryq. Some of it could come from other causes, such as changes in the disease over time or in how often doctors chose to operate.
The numbers are also small. The first trial had 32 people3, and the second-year look covered 28 of them2. The second-year study looked back at past records rather than following patients forward under a fresh plan2. The percentages above come from Inovio’s own summary of the work2. The sources available for this article do not spell out what further studies, if any, the FDA has asked for after this accelerated approval. They also do not say how long the benefit lasts beyond the second year.
Who is behind it
Inovio Pharmaceuticals, listed on the Nasdaq as INO, develops DNA medicines for HPV-related diseases, cancer and infectious diseases1. It sponsored the main trial3 and is the source of the efficacy figures quoted here2. Its president and CEO is Jacqueline Shea1.
Until this decision, Inovio had no approved product. In September its CEO described it as a clinical-stage company1. In its August report on the second quarter of 2026, Inovio described a smaller net loss than before, preparations for a possible launch, and funding expected to last through late in the first quarter of 20271. That means a lot rides on this product for the company.
How it fits the field
RRP is uncommon. Inovio cites data suggesting about 14,000 people in the US live with it, with about 1.8 new cases a year for every 100,000 people2. Because the growths come back, the number of surgeries a patient needs is a central measure of the disease. That is the outcome the approval focuses on1.
Voceryq takes an immune approach. Rather than removing growths directly, it tries to prompt the body’s own T cells to attack tissue infected with the two HPV strains behind the disease2. Inovio’s wider pipeline targets other HPV-related diseases, cancer and infectious diseases with the same type of DNA medicine1. The approval for adults with RRP is the first time this approach has reached the market for the company.
What to watch next
- Follow-up requirements. Whether the FDA’s approval letter and Inovio’s later filings describe a confirming study, and what it will measure.
- Longer-term results. Whether surgery counts stay low beyond the second year without more doses, a question the current data only partly address2.
- Other regions. The treatment holds Orphan Drug designation in Europe and an Innovation Passport in the UK2. Watch for filings there.
- Launch and money. How Inovio funds the rollout, given cash it said would last into early 20271.
This article reports a regulatory decision and the company’s data behind it. It is not medical advice.
