Shares of Outlook Therapeutics OTLK rallied 35.3% on Tuesday after the company announced that the FDA accepted the resubmitted Biologics License Application (BLA) for ONS-5010/Lytenava, its investigational treatment for neovascular age-related macular degeneration (wet AMD). The FDA classified the filing as a Class 1 resubmission, allowing a review decision within 60 days of receipt, and set a decision date of July 29, 2026.

Management said the acceptance marks the final stage of the regulatory review process, with discussions now focused on product labeling ahead of a potential approval decision. Outlook Therapeutics has already begun pre-launch preparations in anticipation of a favorable outcome.

If approved, Lytenava would…