Inovio details Voceryq launch plans and confirmatory study timeline after FDA accelerated approval

Inovio Pharmaceuticals said on October 30, 2026, the same day the FDA granted accelerated approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for adults with recurrent respiratory papillomatosis, that the company expects to make Voceryq available to order and ship in approximately 60 days and anticipates full field deployment during the first quarter of 2027.¹ Inovio has engaged Syneos Health to support the recruitment and deployment of its medical and commercial field teams.¹

On the regulatory side, a confirmatory study is expected to verify Voceryq's clinical benefit, and the FDA requires Inovio to submit a draft protocol for the study by the end of 2026, with the expectation of aligning on a final protocol by mid-2027.¹ Voceryq was approved in combination with CELLECTRA 5PSP, Inovio's proprietary DNA medicine delivery device.¹

Inovio also said in its October 30 release that based on ongoing analysis of claims data, it believes there is a prevalent population of at least 25,000 patients with RRP in the United States, with additional patients diagnosed each year.¹

Separately, an 8-K filing signed November 2, 2026 confirmed these same disclosures and noted that on November 2, 2026 Inovio planned to hold a corporate presentation via teleconference to discuss the approval, with slides furnished as an exhibit and posted to Inovio's investor relations website.¹

The underlying clinical results and FDA basis for approval, including the 27% complete response rate among 26 evaluable patients and the safety profile, were previously reported and remain unchanged.