Biotechnology company Inovio saw its shares jump after the US FDA communicated that data from Inovio completed Phase 1/2 trial of INO-3107 for treating Recurrent Respiratory Papillomatosis (RRP) could support the submission of a Biological License Application (BLA) for review under the FDA's accelerated approval program.
Shares of the company gained around 54% on Tuesday in midday New York trading.
In essence, Inovio’s previously planned Phase 3 trial is no longer necessary for the BLA submission.
If approved, INO-3107 would be the first DNA medicine available in the United States and the first commercial product for Inovio.
INO-3107 holds promise for patients grappling with RRP, a debilitating rare disease caused by the human papillomavirus (HPV).
Pennsylvania-based Inovio recently received Breakthrough Therapy Designation for INO-3107 for RRP treatment, indicating a potentially accelerated pathway for its development.
Inovio said it is now focused on refining its development plan to support the BLA submission for accelerated approval.