Inovio Shares Drop After FDA Says No Plans to Discuss INO-3107 Application

Dow Jones2025-12-29

By Chris Wack

Inovio shares were 22% lower, at $1.80, after the company said the Food and Drug Administration accepted its Biologics License Application for INO-3107 for review as a potential treatment for adults with recurrent respiratory papillomatosis, but has no plans to discuss the application.

The Plymouth Meeting, Pa., biotechnology company said on Monday that the review classification designated by FDA is Standard.

The FDA assigned INO-3107 a prescription drug user fee act, or PDUFA, review goal date of Oct. 30, 2026, which is the date by which it intends to take action on the application.

The FDA has indicated that it isn't currently planning to hold an advisory committee meeting to discuss this application.

Inovio said it 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 hasn't submitted adequate information to justify eligibility for the accelerated approval pathway.

Inovio said it believes that INO-3107 provides a meaningful therapeutic benefit over existing treatments and fulfills the criteria for accelerated approval. The company plans to request a meeting with FDA to discuss next steps to remain eligible under the accelerated approval program.

The company said it isn't currently planning to seek approval for INO-3107 under the traditional pathway.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

December 29, 2025 10:39 ET (15:39 GMT)

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