FDA Approves Inovio’s First Treatment, Sending Shares Up 215% in Extended Trading

Key Facts

The U.S. Food and Drug Administration approved Voceryq, Inovio’s first approved product, to treat adults with recurrent respiratory papillomatosis, giving the company a path toward commercialization after years of clinical development. Reuters said the approval marks the company’s first approved product, while the FDA described it as the first U.S. approval for a plasmid DNA-based immunotherapy. The approval came through the accelerated pathway, based on clinical data showing that the treatment helps reduce the frequency of surgical procedures. Inovio shares rose 215% in extended trading on October 30, according to Reuters, as investors reacted to the regulatory decision. The source did not confirm that sales had begun or that commercial revenue had been generated, so the step remains a potential prelude to launch rather than an announcement of actual sales.

The disease targeted by the treatment is chronic and rare, and is caused by types of human papillomavirus that lead to wart-like growths in the respiratory tract. These growths often appear near the larynx and vocal cords and can cause hoarseness, chronic cough and voice changes. The disease may require repeated surgeries to remove the growths, making the frequency of surgery a key measure in evaluating treatment. According to company data, the average number of surgeries per year fell by 78% in the second year after treatment compared with the preceding year. The average was 0.9 surgeries among 28 patients in the second year, versus 4.1 surgeries among 32 patients in the period before treatment. The FDA cited the reduction in the frequency of procedures as an intermediate clinical endpoint likely to predict clinical benefit, according to its statement.

The regulatory review process reflects some of the uncertainty that preceded the decision: Inovio submitted its marketing application through the accelerated approval pathway, but the FDA said when it accepted the application that the submitted information might not justify the treatment’s eligibility for that pathway. The agency said at the time that this issue represented a potential review point, before granting the treatment accelerated approval based on the clinical data. The pathway requires the company to conduct post-approval clinical trials to verify and describe the treatment’s clinical benefit. The regulatory assessment therefore does not end with the approval decision, as the results of subsequent studies remain part of the approval requirements. The surgery-reduction data that supported the decision also directly relate to the measure the company said improved after treatment.

Voceryq is administered by intramuscular injection using the CELLECTRA 5PSP device, according to the FDA. The device delivers the dose and helps introduce it into cells through short electrical pulses. The treatment is Inovio’s first approved product, while the agency described it as the first of its kind in the United States among plasmid DNA-based immunotherapies. The company is thus moving from developing a treatment candidate to addressing the requirements for launching an authorized product, but the approval alone does not establish that marketing or revenue has begun. In August, the company said that cash and cash equivalents and short-term investments were expected to fund operations through late in the first quarter of 2027, including a potential launch of the treatment if it received approval. That financial estimate now comes in the context of the approval, while the timing of an actual launch remains unspecified in the available information.

In regular trading before the approval announcement, INO shares closed at $0.7718 on October 29, 2026, according to EL7 data. Reuters reported that the stock jumped 215% in extended trading on October 30, a move separate from the closing price recorded the previous day. The comparison highlights the stock’s sharp reaction to the news, without making the percentage gain a closing price for a full trading session. The data provided do not include October 29 session opening, high or low prices, so that day’s figure is limited to the close. The next regulatory step announced is to conduct post-approval trials to verify and describe the treatment’s clinical benefit. The company said available liquidity was expected to fund its operations through late in the first quarter of 2027, covering a potential launch if the company proceeds with one.