Outlook Therapeutics resubmits BLA for ONS-5010 (wet AMD) to FDA after Sept 2025 Type A meeting

Outlook Therapeutics, Inc.

Resubmitted BLA on Nov 3, 2025 for ONS-5010 (LYTENAVA) to treat wet AMD.
Resubmission follows FDA Type A meeting in Sept 2025; aims to resolve CRL issued Aug 2025.
CEO Bob Jahr says resubmission marks 'important step forward' for potential near-term U.S. approval.
Company accelerating commercial efforts in Europe while positioning for U.S. approval.

item 8.01 item 9.01

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