FDA grants accelerated approval to Inovio's VOCERYQ for adult RRP
On Oct. 30, 2026, the U.S. Food and Drug Administration granted accelerated approval to Inovio's VOCERYQ, a plasmid DNA immunotherapy intended to reduce surgery frequency in adults with recurrent respiratory papillomatosis. In the supporting study, 7 of 26 patients, or 27%, required no surgical excision after 12 months. Inovio expects to begin orders and shipments in approximately 60 days, followed by a full commercial launch in the first quarter of 2027.
Why it matters
The approval gives Inovio its first commercial product and creates a regulatory path to market, but continued approval depends on verification of clinical benefit in a confirmatory study. The FDA requires Inovio to submit a draft confirmatory-study protocol by the end of 2026, with final-protocol alignment expected by mid-2027.
Key facts
- 1The FDA granted accelerated approval for VOCERYQ to reduce the frequency of surgery in adults with recurrent respiratory papillomatosis. prnewswire.com
- 2In the efficacy population, 7 of 26 patients, or 27%, required no papilloma surgical excision after 12 months of follow-up. prnewswire.com
- 3Inovio expects VOCERYQ to be available to order and ship in approximately 60 days, with full commercial deployment in the first quarter of 2027. prnewswire.com
- 4The FDA requires a draft confirmatory-study protocol by the end of 2026 and expects alignment on a final protocol by mid-2027. prnewswire.com
Summary written by AlphAI AI Desk from 9 of 9 sources. Not investment advice. Figures are as stated by the linked sources.