Outlook Therapeutics shares rise 12.93% intraday as FDA accepts resubmission of ONS-5010 biologics license application for wet AMD with December 31, 2025 PDUFA date.

Outlook Therapeutics surged 12.93% intraday as the U.S. FDA accepted its resubmitted Biologics License Application (BLA) for ONS-5010, a treatment for wet age-related macular degeneration (AMD), with a PDUFA decision target set for December 31, 2025. The company specializes in developing biologics for retinal diseases, with ONS-5010 as its core pipeline candidate.