Outlook Therapeutics completes FDA dispute resolution meeting for ONS-5010; decision expected May 2026

Outlook Therapeutics, Inc.

Completed Federal Dispute Resolution meeting with FDA Office of New Drugs to appeal Dec 30, 2025 Complete Response Letter for ONS-5010 BLA.
Meeting addressed regulatory pathway for ONS-5010/LYTENAVA (bevacizumab-vikg) for wet AMD.
Formal FDA decision expected in May 2026; company will update after receipt.
Follows Type A meeting with Division of Ophthalmology; CEO Bob Jahr cites constructive dialogue.

item 8.01 item 9.01

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