INOVIO (NASDAQ:INO) said the U.S. Food and Drug Administration has accepted for review its Biologics License Application for INO-3107, a DNA medicine being developed as a potential treatment for adults with recurrent respiratory papillomatosis, a rare disease caused by human papillomavirus.
The company said the FDA assigned the application a standard review and set a Prescription Drug User Fee Act action date of Oct. 30, 2026.
The regulator indicated it is not currently planning to convene an advisory committee to review the application.
INOVIO submitted the BLA under the accelerated approval pathway, but the FDA said in its filing acceptance letter that it has preliminarily concluded the company did not provide sufficient information to justify eligibility for that pathway.
INOVIO said it continues to believe INO-3107 offers a meaningful therapeutic benefit over existing treatments and meets the criteria for accelerated approval, and plans to request a meeting with the FDA to discuss next steps.
The company said it is not currently pursuing approval under the traditional pathway.
“We believe there remains a critical unmet need among patients diagnosed with this rare and devastating disease,” President and Chief Executive Officer Jacqueline Shea said in a statement.
She cited INO-3107’s mechanism of action, clinical activity, tolerability, and a patient-centric regimen that does not require additional surgeries during the dosing period.
The BLA is supported by data from a Phase 1/2 trial in adult RRP patients who had undergone at least two surgeries in the year prior to treatment.
INOVIO also included long-term durability data from a retrospective follow-up of trial participants, showing that most evaluable patients continued to experience clinical benefit during a second 12-month period without additional dosing.
The data have been published in Nature Communications and The Laryngoscope.