Inovio's INO-3107 BLA review advances toward October 30 PDUFA date

Inovio Pharmaceuticals reported on August 12, 2026 that the FDA's review of its Biologics License Application for INO-3107, a treatment for recurrent respiratory papillomatosis, is continuing to advance under the agency's accelerated approval program with a target action date of October 30, 2026¹. The company said the late-cycle review meeting and all scheduled pre-licensure inspections have been completed¹.

Inovio also disclosed that during an informal clinical meeting where it presented data on INO-3107's safety and efficacy, the FDA did not address a preliminary comment made in its file acceptance letter concerning accelerated approval eligibility¹. The company said the FDA indicated that feedback on the design of the confirmatory trial would come later¹. Inovio maintained its own view that INO-3107 fulfills the criteria for accelerated approval by meeting an unmet clinical need and providing a meaningful therapeutic benefit over existing treatments¹.

Ahead of a possible 2026 approval, the company said it is building out commercial infrastructure and has engaged Syneos Health to recruit and deploy Medical Science Liaisons, with Syneos Health also acting as its contract sales organization for U.S. commercialization¹.

Separately, Inovio's China partner ApolloBio reported in May 2026 that its pivotal Phase 3 trial of VGX-3100 for cervical dysplasia met its primary efficacy endpoint with an overall favorable safety profile¹, which ApolloBio said it plans to use to support a future Chinese regulatory filing.

On finances, Inovio said its cash, equivalents and short-term investments totaled $36.7 million at the end of the second quarter, not counting the roughly $18.3 million in net proceeds from its July 2026 offering¹. Including that offering, the company said its resources are expected to support operations into late first quarter 2027, covering a potential INO-3107 launch if approved¹.