FDA accepts resubmitted BLA for Outlook's ONS-5010; PDUFA date July 29, 2026

Outlook Therapeutics, Inc.

• FDA acknowledged receipt of resubmitted BLA for ONS-5010 (bevacizumab-vikg) to treat wet AMD.
• Class 1 review with 60-day review period; PDUFA target action date set for July 29, 2026.
• If approved, ONS-5010 would be first FDA-approved ophthalmic bevacizumab with standardized manufacturing & labeling.
• Company has initiated pre-launch activities in anticipation of potential BLA approval.