RegulatoryCompany release

FDA grants accelerated approval to Inovio's VOCERYQ for recurrent respiratory papillomatosis

🇺🇸 Inovio Pharmaceuticals, Inc. (INO) · Tue 10 Nov 2026

Inovio says the US regulator cleared its DNA medicine, used with the CELLECTRA 5PSP device, to reduce surgery frequency in adults with the rare airway disease.

Inovio Pharmaceuticals announced, alongside its third-quarter 2026 results, that the US Food and Drug Administration granted accelerated approval to VOCERYQ on 30 October 2026. The company describes the product as the first DNA medicine to reach approval.

VOCERYQ is used together with the CELLECTRA 5PSP device. It is indicated to reduce the frequency of surgery in adults with recurrent respiratory papillomatosis.

The approval rests on a study of 32 patients. As is usual under the accelerated pathway, which allows earlier access on the basis of surrogate or intermediate evidence in serious conditions, a confirmatory trial is required. Inovio says it plans one and expects to submit a draft protocol to the FDA by the end of 2026.

On commercial timing, the company expects orders to ship about 60 days after approval, with a full launch in the first quarter of 2027. It also plans to file a conditional marketing authorisation application in Europe before the end of 2026.

What it means for your team

  • Regulatory teams should note the confirmatory trial: a draft protocol is due to the FDA by end-2026, and the design will shape the product's long-term status.
  • Because VOCERYQ is paired with the CELLECTRA 5PSP device, drug-device combination requirements will matter for supply, labelling and post-market oversight.
  • Market-access and launch planners can work to the stated timeline: shipments about 60 days after approval and full launch in Q1 2027.
  • A European conditional marketing authorisation filing is flagged before end-2026; the EMA's view of a 32-patient dataset will be the next test.

Company's press release (SEC filing): Inovio Pharmaceuticals, Inc. ↗

Article written by VigiEye from the official source (Inovio Pharmaceuticals, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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