Outlook Therapeutics, Inc.
ONS-5010
wet AMD
Resolved
189days ago
FDA decision · Dec 30, 2025
What's at stake
An FDA complete response letter on ONS-5010 for wet AMD is in focus around Dec 30, 2025.
Primary source
· SEC 8-K
verified 14h ago
“On December 31, 2025, we reported that we had received a third Complete Response Letter, or CRL, with respect to our Biologics License Application, or BLA, for ONS-5010, and the U.S. Food and Drug Administration, or FDA, has again recommend”