FDA Grants Accelerated Approval to Inovio's Voceryq for Rare Respiratory Disease, Sending Shares Up More Than 280%

The US Food and Drug Administration on October 30 granted accelerated approval to Inovio Pharmaceuticals' Voceryq, formerly known as INO-3107, as an immunotherapy to reduce the frequency of surgery in adults with recurrent respiratory papillomatosis, a rare and debilitating condition caused by HPV-6 and HPV-11 in which tumors grow in the respiratory tract. The approval marks Inovio's first-ever commercial product after years of clinical-stage development and came on the PDUFA target date the FDA had set following its acceptance of the biologics license application in December 2025.

Shares of Inovio surged between 280% and 300% in after-hours trading following the announcement, reflecting the milestone significance for a company that had not previously brought a product to market. The approval came under the accelerated approval pathway, a regulatory route Inovio had strongly advocated for even after the FDA flagged in its file acceptance letter a preliminary concern about whether INO-3107 met the eligibility criteria for that pathway.

The news dealt a sharp blow to rival Precigen, whose PAPZIMEOS had been the existing treatment for RRP and had been generating accelerating revenue, reaching $53.1 million in the second quarter of 2026. Precigen shares fell 27% in after-hours trading as investors weighed the competitive threat from Voceryq entering the market.