VOCERYQ (INO-3107) was approved by the FDA on October 30, 2026 for recurrent respiratory papillomatosis (adults).
Verified against: FDA action day October 30, 2026 (FDA press announcement) · Announcement October 30, 2026 (INOVIO press release) · Goal date October 30, 2026 (INOVIO PHARMACEUTICALS, INC. 8-K).
The FDA granted accelerated approval to Voceryq, the first plasmid DNA-based immunotherapy approved in the U.S., to reduce the frequency of surgery in adults with recurrent respiratory papillomatosis. Continued approval depends on confirmatory trials.
The FDA's press announcement of October 30, 2026 states that the agency granted accelerated approval that day to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for adults with recurrent respiratory papillomatosis (RRP) (FDA, October 30, 2026). INOVIO announced it the same day (INOVIO's announcement). The goal date was October 30, 2026 (INOVIO 8-K, May 13, 2026), so the decision came on the goal date. Per the FDA, the accelerated approval rests on a reduction in the frequency of surgical procedures needed to remove papillomas, an intermediate endpoint reasonably likely to predict clinical benefit, and the manufacturer must run post-approval trials to verify it. Voceryq is reviewed by CBER, so it has no Drugs@FDA record; the FDA's announcement is the FDA record of the action day. INOVIO says it expects to make Voceryq available to order in about 60 days, with full commercial launch in the first quarter of 2027.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Primary source: FDA press announcement, October 30, 2026
FDA record of the action: the FDA approved on October 30, 2026, per FDA press announcement, October 30, 2026 (CBER product; not in Drugs@FDA) (FDA notice). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Yes. The FDA approved the application for Voceryq (INO-3107) on October 30, 2026, per the FDA's own record. The primary source is linked on this page.
Voceryq (INO-3107) is an INOVIO Pharmaceuticals (INO) program. The FDA decision came on October 30, 2026; the company's own announcement is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), INO moved -46.0%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.