Record mula sa primary source
Ang FDA ay nagtakda ng target action date ng PDUFA na October 30, 2026 para sa BLA ng INOVIO para sa INO-3107 sa Recurrent Respiratory Papillomatosis. Ang pagsusuri ay isinasagawa sa ilalim ng accelerated approval program, na may lahat ng naka-iskedyul na pre-licensure inspections na nakumpleto at isang informal clinical meeting na ginanap. Ang INOVIO ay nagpapatuloy sa mga paghahanda para sa commercial launch bago ang potensyal na pag-apruba sa 2026.
EX-99.1 2 ino-63026x8kex991.htm EX-99.1 Document Exhibit 99.1 INOVIO Reports Second Quarter 2026 Financial Results and Recent Business Highlights • U.S. Food and Drug Administration (FDA) review of Biologics License Application (BLA) for INO-3107 as a treatment for Recurrent Respiratory Papillomatosis (RRP) advancing with a target Prescription Drug User Fee Act (PDUFA) date of October 30, 2026 • Commercial preparations advancing in anticipation of potential product launch for INO-3107 • Positive topline results reported from Phase 3 trial for VGX-3100 for the treatment of cervical dysplasia patients by ApolloBio, INOVIO’s partner in China • Presented promising data from next-generation DNA-Encoded Monoclonal Antibody (DMAb™) and DNA-Encoded Protein (DPROT) programs at several scientifi