Outlook Therapeutics shares rise 16.24% intraday after FDA accepts resubmitted BLA for ONS-5010, a potential first FDA-approved ophthalmic bevacizumab for wet AMD.

Outlook Therapeutics surged 16.24% intraday as the FDA accepted its resubmitted BLA for ONS-5010 bevacizumab on November 13, 2025, setting a PDUFA date of December 31, 2025. The therapy targets wet AMD and would become the first FDA-approved ophthalmic bevacizumab treatment, addressing an off-label use gap.