Inovio Advances BLA to October 30, 2026, Secures $16M and GBM Collaboration
INO•Inovio’s BLA for INO-3107 under FDA accelerated review targets an October 30, 2026 PDUFA date as the company advances commercial readiness for RRP patients. Proceeds of approximately $16.0 million and existing cash are expected to fund operations into Q1 2027 while a new GBM trial collaboration begins.
1. BLA Review and Commercial Readiness
Inovio’s Biologics License Application for INO-3107 is under active accelerated review with the FDA following a completed mid-cycle meeting, and the company targets an October 30, 2026 PDUFA date. Commercial readiness plans include partnerships with contract sales organizations, specialty distributors, and patient HUB providers to support a potential launch.
2. GBM Clinical Trial Collaboration
In March 2026 Inovio entered a clinical trial collaboration and supply agreement with Akeso Inc. to evaluate INO-5412 in combination with cadonilimab as part of the INSIGhT Phase 2 glioblastoma trial sponsored by Dana-Farber Cancer Institute, expanding its oncology pipeline.
3. Financing and Cash Runway
In April 2026 Inovio completed an underwritten public equity offering, netting approximately $16.0 million in proceeds. Combined with existing cash, cash equivalents and short-term investments, the company anticipates funding operations into the first quarter of 2027, beyond the target PDUFA date.
4. Next-Generation Pipeline Progress
Inovio continues advancing its next-generation DNA-encoded monoclonal antibody and protein platforms, presenting positive preclinical data on Factor VIII production for Hemophilia A and exploring indications in Fabry disease and Hypophosphatasia, while engaging potential partners to accelerate development.
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