WASHINGTON — The U.S. Food and Drug Administration on Friday, October 30, 2026, approved Inovio Pharmaceuticals’ treatment for a rare respiratory condition that causes wart-like growths in the airways, marking the company’s first approved product and sending its shares sharply higher in extended trading. The therapy, previously known by its development code INO-3107 and now branded Voceryq, gives adults living with recurrent respiratory papillomatosis a new non-surgical treatment option for a disease that has long been managed mainly by cutting the growths away, only for them to return.
Shares of Inovio were up 286 percent in extended trading after the announcement, according to Reuters, a reaction that reflects how much was riding on the decision for a company that, until now, had never brought a product through the FDA to approval. The approval was granted under the FDA’s accelerated approval programme, which allows a treatment for a serious condition to reach patients based on early evidence of benefit while further studies confirm that benefit. Continued approval may depend on verification of the clinical benefit in confirmatory studies, a standard condition of the accelerated pathway.
Recurrent respiratory papillomatosis, often shortened to RRP, is a rare and debilitating disease in which benign growths called papillomas develop in the respiratory tract, most often on the vocal cords and in the voice box. The condition is usually caused by human papillomavirus types 6 and 11, the low-risk HPV types best known for causing genital warts rather than cancer. In RRP, however, the virus drives repeated growth in the delicate tissues of the airway, where even small lesions can interfere with speech and breathing. Because the growths tend to come back, many patients need multiple operations each year, and every operation carries a risk of permanent damage to the vocal cords, which can change or diminish a person’s voice for life.
Until recently, surgery was effectively the only option. Doctors treated RRP by surgically removing the growths, a procedure known as debulking, and then waited for the next recurrence. That changed last year, when Precigen’s Papzimeos became the first medicine to receive U.S. approval for the disease in adults. Voceryq now becomes the second approved treatment, and the first to use a DNA-based approach, giving physicians and patients a choice between two immunotherapies that aim at the same viral targets through different mechanisms.
What the FDA Approval of Inovio’s Voceryq Means for Patients
Voceryq is approved to reduce the frequency of surgery in adults with recurrent respiratory papillomatosis. More precisely, the approval covers reducing the frequency of surgical removal of papilloma growths, with the benefit measured in the supporting study by complete response, defined as no requirement for surgical intervention in the 12 months after treatment among the patients evaluated for efficacy. That framing matters for patients’ expectations: the treatment is designed to cut down how often surgery is needed, not to guarantee that surgery will never be needed again, and its longer-term benefit still has to be confirmed in further study.
The therapy itself is a plasmid DNA-based immunotherapy. It uses DNA plasmids that encode antigens from HPV types 6 and 11, with the aim of prompting the patient’s own immune system to recognise and respond to the virus driving the disease. It is given with Inovio’s proprietary CELLECTRA delivery device, and the dosing regimen runs over nine weeks. Treatment begins with a standard surgical debulking of visible papilloma before the first dose, so that the immunotherapy starts from a cleared airway, and no additional surgical intervention is required as part of the nine-week regimen itself. Inovio has described Voceryq as the first FDA-approved DNA medicine, a milestone the company says validates its broader platform for DNA-based medicines against HPV-related diseases, cancer and infectious diseases.
The application was supported by an early-to-mid-stage study in adults who had undergone at least two surgeries in the previous year, a group whose disease was clearly active and recurring. In the company’s announcement of the approval, the study’s lead investigator, Dr. Simon Best, an associate professor of otolaryngology at Johns Hopkins University, said the treatment was found to be well tolerated. All 32 patients in the study completed it, according to the announcement. The most common adverse reactions reported, occurring in more than 5 percent of patients, were injection-site reactions, headache, fatigue, hypertension, nausea and dizziness. Most treatment-related adverse reactions were grade 1 and 2, the milder end of the grading scale, and transient, and there were no grade 4 or 5 common adverse events, the company said. The FDA’s own summary of the most commonly reported reactions matched that list.
Patients and clinicians should still read those safety findings carefully. The study was small, as is common in rare diseases, and the list of common reactions describes what was seen most often, not every possible effect. Hypertension, or raised blood pressure, appearing among the common reactions is a reminder that even a treatment designed to work through the immune system can have effects beyond the injection site, and that blood pressure and general health will be part of follow-up care. Anyone considering the treatment should discuss the full safety information, including the complete prescribing information, with their specialist, rather than relying on headlines about tolerability.
The contrast with Precigen’s Papzimeos is instructive. Both therapies are designed to generate immune responses against HPV types 6 and 11, but they do so differently. Papzimeos uses a modified virus to trigger an immune response, while Voceryq uses DNA plasmids delivered by a device. Inovio’s chief executive, Jacqueline Shea, told Reuters ahead of the decision that physicians are primarily looking for therapies that reduce the need for surgery, precisely because each operation risks permanent vocal cord damage. For patients who have already endured many procedures, the practical difference between the two options may come down to their treatment history, their specialist’s experience, access and availability, and how they respond, questions that only wider clinical use will begin to answer.
Regulatory history adds context to the approval. The FDA had previously granted Voceryq both Orphan Drug and Breakthrough Therapy designations, recognising the rarity of RRP and the potential for a meaningful advance over existing care. The European Commission has also granted the treatment, under its INO-3107 code, Orphan Drug designation. Those designations do not guarantee approval, but they reflect the agency’s view that the disease is serious, underserved and in need of new options. The clinical data behind the approval were published in Nature Communications and in The Laryngoscope, the specialist journal for the ear, nose and throat physicians who treat RRP, giving the wider medical community a chance to examine the evidence in detail.
Commercially, the approval transforms Inovio from a development-stage biotechnology company into a company with a product to sell. Inovio plans to commercialise the therapy in the United States itself, rather than handing sales to a larger pharmaceutical partner, and it has engaged Syneos Health to support the launch. The company expects to make Voceryq available to order and ship in approximately 60 days, with full field deployment during the first quarter of 2027, and it scheduled a conference call for Monday, November 2, 2026, to discuss the approval. Building a sales and distribution operation for a rare disease is a different challenge from running a clinical trial: the patient population is small and scattered, the treating specialists are concentrated in major centres, and the device-based delivery means training and logistics matter as much as the medicine itself.
The market reaction, dramatic as it was, should be read with the same caution as any single day’s trading. A rise of 286 percent in extended trading reflects investor excitement about a first approval and a first-of-its-kind DNA medicine, but extended-hours trading is typically thinner and more volatile than regular trading, and the company’s longer-term value will depend on the confirmatory study, the pace of the commercial launch, how many eligible patients actually receive the treatment, and whether insurers cover it. Inovio’s own announcement notes that the FDA requires a draft protocol for the confirmatory study by the end of 2026, with the aim of agreeing a final protocol by mid-2027, a timetable that will keep the approval under scrutiny well into next year.
For the wider field of DNA medicines, the decision is a landmark regardless of how Voceryq itself performs commercially. DNA-based immunotherapies have been studied for decades, but none had previously won FDA approval in the United States. Inovio’s success may encourage further investment in the approach, not only for HPV-related disease but for other conditions where teaching the immune system to recognise a specific target could reduce the need for repeated procedures or long-term drug treatment. At the same time, regulators and researchers will watch the confirmatory study closely, because accelerated approvals rest on a bargain: earlier access for patients with few options, in exchange for rigorous proof that the benefit is real and lasting.
For patients living with RRP, the practical message of October 30 is narrower and more personal. A second approved treatment now exists, one that aims to reduce how often they need surgery and to protect the voice that repeated operations put at risk. It is not a cure, and it does not remove the need for specialist care, follow-up or, in some cases, further surgery. But for people whose lives have been organised around operating-room schedules, voice therapy and the anxiety of the next recurrence, fewer surgeries would be a meaningful change, and the arrival of a new option, alongside Papzimeos, gives them and their doctors something they did not have two years ago: a choice. Readers can also follow other recent regulatory decisions, including the FDA easing warnings on three more menopause patches and the FDA proposal on vitamin D and iodine in infant formula.
Sources
USN reviewed reporting from multiple outlets for this story. Read more from Reuters, PR Newswire and Seeking Alpha.