INO News & Events

INOVIO announced that the U.S. Food and Drug Administration, FDA, accepted the company's Biologics License Application, BLA, for INO-3107 for review as a potential treatment for adults with RRP. The review classification designated by FDA is Standard. The FDA assigned INO-3107 a Prescription Drug User Fee Act, PDUFA, review goal date of October 30, 2026, which is the date by which it intends to take action on the application. The FDA has indicated that it is not currently planning to hold an advisory committee meeting to discuss this application. INOVIO filed its BLA under the accelerated approval pathway. In the file acceptance letter, the FDA noted as a potential review issue its preliminary conclusion that the company has not submitted adequate information to justify eligibility for the accelerated approval pathway. INOVIO continues to believe that INO-3107 provides a meaningful therapeutic benefit over existing treatments and fulfills the criteria for accelerated approval. INOVIO plans to request a meeting with FDA to discuss next steps to remain eligible under the accelerated approval program. INOVIO is not currently planning to seek approval for INO-3107 under the traditional pathway.

Inovio Pharmaceuticals announced the pricing of an underwritten public offering of 13,158,000 shares of its common stock at a public offering price of $1.90 per share. All of the shares of common stock in the offering are being sold by Inovio. The offering is expected to close on or about November 12. Piper Sandler & Co. is acting as sole manager for the offering.

Inovio Pharmaceuticals announced that it intends to offer and sell shares of its common stock in an underwritten public offering. All of the shares of common stock in the proposed offering will be sold by Inovio. Piper Sandler & Co. is acting as sole book-running manager for the offering.