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[HEALTH] · United States · 5 sources

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Part of situation: FDA approval of INOVIO DNA immunotherapy (2 clusters)

FDA grants accelerated approval to INOVIO's VOCERYQ for RRP

INOVIO VOCERYQ FDA approval Recurrent Respiratory Papillomatosis DNA medicine

The U.S. Food and Drug Administration has granted accelerated approval to VOCERYQ (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for the treatment of adults with Recurrent Respiratory Papillomatosis (RRP). This DNA-based immunotherapy, developed by INOVIO, is indicated to reduce the frequency of surgeries required to treat the rare disease, which is caused by HPV-6 and HPV-11 infections.

The approval is based on clinical data showing a complete response, where patients in the efficacy population required no surgical intervention for 12 months following treatment. VOCERYQ is intended for use with CELLECTRA 5PSP, INOVIO's proprietary DNA medicine delivery device.

As a condition of the accelerated approval, INOVIO must conduct confirmatory studies to verify clinical benefits. The company is expected to submit a draft protocol for these trials by the end of 2026, with plans to finalize the protocol by mid-2027. INOVIO expects to make the treatment available for order in approximately 60 days, with a full commercial launch planned for the first quarter of 2027.

Entities

CELLECTRA 5PSP · INOVIO Pharmaceuticals · Jacqueline Shea · U.S. Food and Drug Administration · VOCERYQ

Claims

What the coverage asserts, and how many sources carry each claim.

Sources

FDA Approves First DNA Medicine as Inovio Shares Soar 257% on Voceryq Nod - QUE.com [que.com]
Seven of 26 adults with a rare airway disease had no surgery for a year after treatment. FDA approved INOVIO's treatment. [www.stocktitan.net]
INOVIO Pharma Soars As FDA Grants Accelerated Approval For VOCERYQ In Adult RRP | 31.10.26 [www.finanzen.at]
INOVIO Pharma Soars As FDA Grants Accelerated Approval For VOCERYQ In Adult RRP | 31.10.26 [www.finanzen.ch]
KXCO's FDA ontology ranked INO-3107 first for nine days. The FDA approved it on 30 October. [www.livetradingnews.com]