Inovio Pharmaceuticals' Ino-3107 Faces FDA Concerns Over Accelerated Approval Pathway

Inovio Pharmaceuticals' stock fell 24.38% after the FDA accepted its Biologics License Application for INO-3107, a potential treatment for Recurrent Respiratory Papillomatosis, but raised concerns over the accelerated approval pathway. The FDA assigned a review goal date of October 30, 2026, but indicated it was not planning to hold an advisory committee meeting to discuss the application. Inovio plans to request a meeting with the FDA to discuss next steps under the accelerated approval program.