FDA grants Outlook Therapeutics appeal; BLA resubmission planned for June 2026

Outlook Therapeutics, Inc.

FDA concluded substantial evidence of effectiveness for LYTENAVA (bevacizumab-vikg) for nAMD after FDR appeal.
Company will resubmit BLA as Class 1 in June 2026; PDUFA decision expected within 60 days.
Appeal resolves December 30, 2025 Complete Response Letter; FDA directs final labeling discussions.
NORSE TWO trial results plus confirmatory data from NORSE EIGHT and other evidence supported effectiveness.

item 8.01 item 9.01

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