On October 30, 2026, the U.S. FDA granted accelerated approval to Inovio Pharmaceuticals' Voceryq (INO-3107) for recurrent respiratory papillomatosis, marking Inovio's first commercial product and driving shares up 257%. Voceryq is a DNA-based immunotherapy targeting HPV types 6 and 11 to reduce frequent surgical interventions. Inovio expects availability within 60 days and a full commercial launch in early 2027, alongside required confirmatory studies.
FDA approval and market reaction
- ▪Shares of Inovio Pharmaceuticals surged 257% in extended trading following the U.S. FDA approval of Voceryq on October 30, 2026.
- ▪The U.S. Food and Drug Administration approved Inovio Pharmaceuticals' DNA-based therapy Voceryq (INO-3107) on October 30, 2026 for treating recurrent respiratory papillomatosis, marking Inovio's first approved product.
Accelerated approval and confirmatory study
- ▪The U.S. FDA granted accelerated approval to Voceryq, requiring Inovio Pharmaceuticals to conduct a post-approval confirmatory study to verify the therapy's clinical benefit.
- ▪Inovio Pharmaceuticals expects to submit a draft protocol for Voceryq's FDA-required confirmatory study by the end of 2026 and finalize the study design by mid-2027.
Commercial availability and launch plans
- ▪Inovio Pharmaceuticals expects Voceryq to be available for order and shipment within approximately 60 days of its October 30, 2026 FDA approval.
- ▪Inovio Pharmaceuticals plans a full commercial launch for Voceryq in the first quarter of 2027.
Voceryq mechanism and clinical trial
- ▪Inovio Pharmaceuticals' application for Voceryq was supported by an early- to mid-stage study in adults with recurrent respiratory papillomatosis who had undergone two or more surgeries in the prior year.
- ▪Inovio Pharmaceuticals' Voceryq (INO-3107) is a DNA-based immunotherapy designed to generate an immune response against HPV types 6 and 11 to reduce surgical intervention needs for recurrent respiratory papillomatosis.
Understanding recurrent respiratory papillomatosis
- ▪Recurrent respiratory papillomatosis is a rare condition caused by HPV types 6 and 11 that causes recurrent non-cancerous wart-like growths in the throat and airways, affecting speech and breathing.
- ▪Recurrent respiratory papillomatosis is typically treated by surgically removing airway growths, but many patients require multiple procedures each year because the growths recur, risking permanent vocal cord damage.
Comparison with Precigen's Papzimeos
- ▪While Precigen's Papzimeos uses a modified virus to trigger an immune response against HPV types 6 and 11, Inovio Pharmaceuticals' Voceryq utilizes a DNA-based immunotherapy mechanism.
- ▪Precigen's Papzimeos became the first medicine approved in the U.S. for adults with recurrent respiratory papillomatosis when it received FDA approval in 2025.
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