Inovio Pharmaceuticals has laid off staff and prioritized programs to focus on its lead rare disease candidate, which is already facing some pushback from the FDA early in its approval review.
Inovio disclosed March 12 that the company “has eliminated roles that don’t directly support our primary goal of advancing INO-3107 toward U.S. approval.”
The Pennsylvania-based biotech employed 112 people as of March 11, according to its 2026 annual report (PDF), down from the 134 staffers the company reported in the previous year’s summary (PDF).
INO-3107 is a DNA-based medicine designed to turn T cells against cells infected with certain strains of human papillomavirus. These strains cause tumors to grow in the vocal cords, a rare condition known as recurrent respiratory papillomatosis, which can become deadly if the airway is blocked.
Inovio filed INO-3107 for accelerated approval at the end of December, with the FDA set to make a decision by Oct. 30, 2026. However, the FDA seemingly no longer believes INO-3107 is fit for approval under the accelerated 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,” the biotech explained at the time of its approval application. “Inovio continues to believe that INO-3107 provides a meaningful therapeutic benefit over existing treatments and fulfills the criteria for accelerated approval.”
The agency has agreed to a meeting with Inovio about the issue, which has not yet been scheduled, according to the March 12 report.
Inovio did not respond to Fierce Biotech’s requests for comment about the layoffs and the issues raised by the FDA.
The FDA, through the Department of Health and Human Services’ communications leader Andrew Nixon, declined to comment to Fierce.
INO-3107’s review falls under the purview of Vinay Prasad, M.D., the outgoing director of the Center for Biologics Evaluation and Research. Prasad has come under intense scrutiny during his one-year tenure for his division’s rejection of numerous rare disease therapies, which often ran counter to past guidance received by the companies applying for approval.
The FDA initially OK’d INO-3107 for accelerated approval consideration in October 2023, during the administration of former President Joe Biden. At the time, the agency told Inovio that its single-arm, phase 1/2 trial could support an approval application, the company said. That followed another biotech, Precigen, receiving the same consideration for its own recurrent respiratory papillomatosis candidate.
Precigen’s med later garnered approval in August 2025 as Papzimeos, the first treatment for the rare disease.
