INOVIO received FDA accelerated approval for VOCERYQ, a DNA-based immunotherapy to reduce surgery frequency in adults with recurrent respiratory papillomatosis. The approval is based on a 27% complete response rate in the efficacy population. This is the first FDA-approved DNA medicine. INOVIO expects to ship in about 60 days, with full commercial launch in Q1 2027. A confirmatory study is required, with a draft protocol due by end of 2026. INOVIO will host a conference call on November 2 at 8:00 AM ET.
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