Outlook Therapeutics, Inc. - 8-K Filing

Outlook Therapeutics resubmitted the Biologics License Application for ONS-5010/LYTENAVA™ to the U.S. FDA on June 1, 2026, following a successful appeal of a Complete Response Letter from December 2026. The FDA has designated this as a Class 1 resubmission with a decision expected within 60 days. (Items: 8.01 Other Events, 9.01 Financial Statements and Exhibits)

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