RegulatoryCompany release

FDA grants accelerated approval to Inovio's DNA immunotherapy Voceryq for recurrent respiratory papillomatosis

🇺🇸 Inovio Pharmaceuticals, Inc. (INO) · Mon 02 Nov 2026

Inovio's first product, Voceryq (INO-3107), is approved to reduce surgery frequency in adults with RRP, with continued approval potentially contingent on confirmatory study results.

Inovio Pharmaceuticals has announced that the US Food and Drug Administration has granted accelerated approval to Voceryq, formerly known as INO-3107, for adults with recurrent respiratory papillomatosis (RRP). The product is a DNA immunotherapy and is the company's first to reach the market.

The approved indication is to reduce the frequency of surgery in adults with the condition. According to Inovio, the approval rests on a reduction in surgical papilloma excisions, rather than on a longer-term clinical outcome.

As is the case with accelerated approvals, continued approval may depend on the results of confirmatory studies. Under the FDA's accelerated approval pathway, a drug for a serious condition can be cleared on the basis of an endpoint considered reasonably likely to predict clinical benefit, with verification required after authorisation.

Inovio presented further details on a call covering the label, the safety profile, delivery of the product with the company's CELLECTRA device, and its commercial launch plans. The company said adverse reactions were mostly Grade 1-2 in severity. The summary available does not provide specific figures on efficacy or safety, the confirmatory study design or a launch date.

What it means for your team

  • Regulatory teams should note that the approval is based on a surgical-excision endpoint, with continued approval potentially tied to confirmatory study results.
  • Pharmacovigilance teams should watch post-marketing safety data, given that reported adverse reactions were mostly Grade 1-2 at the time of approval.
  • Because Voceryq is delivered with the CELLECTRA device, quality and device-compliance teams may need to consider the combined drug-device aspects.
  • Market-access teams should look for the full label and launch details before assessing positioning and payer evidence needs.

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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