FDA Grants Accelerated Approval to Inovio's VOCERYQ for Throat Condition
Inovio's VOCERYQ received FDA accelerated approval to reduce surgery frequency in adults with Recurrent Respiratory Papillomatosis.
Inovio Pharmaceuticals reported its third-quarter 2026 financial results alongside a significant regulatory milestone: the U.S. Food and Drug Administration granted accelerated approval to VOCERYQ, the company's treatment for Recurrent Respiratory Papillomatosis, a condition characterized by recurring growths in the respiratory tract that frequently require surgical intervention.
VOCERYQ, whose full scientific name is doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd, is indicated to reduce the frequency of surgery in adult patients living with RRP. The accelerated approval pathway is typically reserved for therapies that address serious conditions and demonstrate a meaningful benefit over available treatments on a surrogate or intermediate clinical endpoint.
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The company said VOCERYQ is expected to be available to order and ship in the near term, signaling a commercial launch phase following the regulatory clearance. The approval marks a notable step for Inovio, which has pursued DNA medicine platforms across multiple disease areas, as it transitions from a development-stage pipeline toward a marketed product with a defined patient population.
RRP is a rare and often debilitating disease caused by human papillomavirus infection of the airway, requiring patients to undergo repeated surgeries — sometimes dozens over a lifetime — to manage obstructive growths. An approved therapy capable of reducing that surgical burden would represent a meaningful shift in the standard of care for affected adults.
Full details of Inovio's third-quarter financial results and additional business highlights were disclosed in the company's earnings release. Continue reading at Earnings.
