Outlook Therapeutics shares rise 14.06% premarket after FDA accepts BLA resubmission for ONS-5010 wet AMD treatment.

Outlook Therapeutics surged 14.06% in premarket trading following the U.S. FDA’s acceptance of its resubmitted Biologics License Application (BLA) for ONS-5010, an ophthalmic formulation of bevacizumab for wet AMD. The FDA classified the resubmission as a complete, Class 1 response to its August 2025 action letter, initiating a 60-day review period with a PDUFA goal date of December 31, 2025. The company emphasized that the resubmission addresses prior regulatory concerns, positioning ONS-5010 as a potential first FDA-approved ophthalmic formulation of bevacizumab for wet AMD in the U.S. Multiple news sources highlighted the milestone, noting its significance in advancing the drug’s regulatory pathway. The stock’s sharp premarket gain directly aligned with these developments, reflecting investor optimism over the therapy’s prospects.