PLYMOUTH MEETING, PA — INOVIO (NASDAQ: INO) announced that the U.S. Food and Drug Administration has agreed to the company’s rolling submission timeline for its Biologics License Application (BLA) for INO-3107, a potential treatment for adults with Recurrent Respiratory Papillomatosis (RRP).
The company expects to complete the submission in the coming months and plans to request priority review, with a goal of receiving FDA file acceptance by the end of 2025.
“We are pleased the FDA agreed to our rolling submission plan. We are also encouraged by their recent activity in recognizing the importance of accelerating the full approval of new technologies that can bring life-changing therapeutic options to patients suffering from rare diseases such as RRP,” said Dr. Jacqueline Shea, INOVIO’s president and chief executive officer. “Based on the totality of our data, we believe INO-3107 has the potential to become the preferred product for the treatment of RRP by patients and providers.”
INO-3107, which has received Breakthrough Therapy designation, is being developed to offer a differentiated therapeutic option for individuals affected by this rare and chronic condition.
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