INOVIO Surges 242% After FDA Accelerated Approval of VOCERYQ for Adult RRP

INOVIO Pharmaceuticals (INO) said Friday the U.S. Food and Drug Administration granted accelerated approval to VOCERYQ, its DNA medicine for adults with Recurrent Respiratory Papillomatosis (RRP). The stock closed the regular session down 21.95% at $0.6024 but soared 241.93% to $2.0598 in after-hours trading. The approval is the first FDA-authorized treatment specifically indicated to reduce surgery frequency in adult RRP patients, a rare chronic disease caused primarily by HPV infection that produces recurrent benign tumors in the respiratory tract. VOCERYQ, previously INO-3107, was cleared on data showing a complete response, defined as no surgical intervention in the 12 months following treatment within the efficacy population. It is INOVIO's first commercial DNA medicine. As a condition of accelerated approval, INOVIO must run a confirmatory study, submitting a draft protocol by the end of 2026 and finalizing it by mid-2027. The therapy is approved with the company's CELLECTRA 5PSP delivery device. INOVIO expects ordering and shipment within about 60 days and full commercial deployment in the first quarter of 2027, supported by a partnership with Syneos Health.