INOVIO PHARMACEUTICALS, INC. 8-K

What Happened

• INOVIO Pharmaceuticals, Inc. (INO) announced on December 29, 2025 that the U.S. Food and Drug Administration (FDA) has accepted its Biologic License Application (BLA) for INO-3107. INO-3107 is an investigational immunotherapy intended to treat adults with recurrent respiratory papillomatosis (RRP). The company furnished a press release about the acceptance (attached as Exhibit 99.1).

Key Details

• FDA action: BLA for INO-3107 accepted for review by the FDA (announcement dated December 29, 2025).
• Product: INO-3107 — investigational immunotherapy for adults with recurrent respiratory papillomatosis (RRP).
• Filing: Press release announcing acceptance was furnished as Exhibit 99.1 to the Form 8-K.
• Regulation FD note: The press release was furnished under Item 7.01 and is not deemed “filed” for purposes of Section 18 of the Exchange Act or incorporated by reference into other filings, except as expressly specified.

Why It Matters

• FDA acceptance of a BLA is a formal step that begins the agency’s review of a biologic for potential approval; this is a key regulatory milestone for INOVIO and INO-3107.
• For investors, this event may affect the company’s near- to mid-term regulatory and commercial prospects for treating RRP if the review leads to approval. The filing itself does not guarantee approval and further FDA review steps and communications will determine next milestones.