प्राथमिक स्रोत रिकॉर्ड
FDA accepted the BLA for INO-3107 under the accelerated approval program and set a target PDUFA date of October 30, 2026. The application is actively under review, including completion of the mid-cycle review meeting. INOVIO continues to advance commercial readiness plans ahead of a potential 2026 approval.
EX-99.1 2 ino-33126x8kex991.htm EX-99.1 Document Exhibit 99.1 INOVIO Reports First Quarter 2026 Financial Results and Recent Business Highlights • Biologics License Application (BLA) for INO-3107 actively being reviewed under the accelerated approval program by the U.S. Food and Drug Administration (FDA) with a target Prescription Drug User Fee Act (PDUFA) date of October 30, 2026 • Commercial readiness plans continue to advance in anticipation of a potential commercial launch for INO-3107 as a treatment for adults with Recurrent Respiratory Papillomatosis (RRP) • Clinical trial collaboration and supply agreement announced with Akeso Inc. to evaluate INO-5412 in combination with cadonilimab for the potential treatment of glioblastoma (GBM) in a Dana-Farber Cancer Institute-sponsored tr