The Food and Drug Administration granted accelerated approval on October 30 to Voceryq, an Inovio Pharmaceuticals immunotherapy intended to reduce the frequency of surgery in adults with recurrent respiratory papillomatosis.

The disease causes wart-like growths in the airways and is associated with human papillomavirus types 6 and 11. Removing the growths surgically does not eliminate the underlying infection, so procedures may need to be repeated.

The FDA described Voceryq as the first plasmid DNA-based immunotherapy approved in the United States. That distinction concerns its technology: it is not the first medicine approved for this disease. Reuters reported that Precigen's Papzimeos received U.S. approval in 2025.

The agency evaluated an open-label, multicenter trial involving 32 adults. In the efficacy group of 26 participants who had undergone at least three baseline surgeries, seven — 27% — required no surgical intervention during the first year after treatment. That percentage applies to the 26-person subgroup, rather than all trial participants.

Accelerated approval relies on an intermediate clinical endpoint considered reasonably likely to predict benefit. The FDA requires post-approval trials to verify and describe that benefit; the decision does not remove the need for further evidence.

Inovio said it expects to begin accepting orders and shipping the medicine in approximately 60 days, with a full commercial launch in the first quarter of 2027. Those are company plans, rather than confirmed availability dates.

Voceryq is given by intramuscular injection with Inovio's CELLECTRA 5PSP delivery device. Commonly reported adverse reactions include injection-site reactions, headache, fatigue, hypertension, nausea and dizziness, according to the FDA.

Inovio said a draft protocol for confirmatory research is due by the end of 2026, with agreement on a final protocol expected by mid-2027.

Sources FDA — October 30 approval announcement: https://www.fda.gov/news-events/press-announcements/fda-approves-first-plasmid-dna-based-immunotherapy-adults-recurrent-respiratory-papillomatosis Inovio — October 30 company announcement: https://www.prnewswire.com/news-releases/inovio-announces-fda-accelerated-approval-of-voceryq-an-immunotherapy-to-reduce-the-frequency-of-surgery-in-adults-with-recurrent-respiratory-papillomatosis-rrp-302925406.html Reuters — October 30 report: https://www.reuters.com/legal/litigation/us-fda-approves-inovios-treatment-rare-throat-disease-2026-10-30/