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A FDA aceitou a BLA para INO-3107 sob o programa de aprovação acelerada e definiu uma data-alvo PDUFA para 30 de outubro de 2026. O pedido está em revisão ativa, incluindo a conclusão da reunião de revisão de meio de ciclo. A INOVIO continua a avançar os planos de preparação comercial antes de uma possível aprovação em 2026.
EX-99.1 2 ino-33126x8kex991.htm EX-99.1 Documento 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 t