OTLK Outlook Therapeutics, Inc. - 8-K

Item 8.01

Other Events.

On May 26, 2026, Outlook Therapeutics, Inc. (the
"Company") issued a press release announcing that the U.S. Food and Drug Administration (FDA) has granted the Company's appeal
following completion of the Formal Dispute Resolution (FDR) process with the Office of New Drugs (OND) regarding the December 30, 2025
Complete Response Letter (CRL) for the Biologics License Application (BLA) for ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the treatment
of neovascular age-related macular degeneration (nAMD).

The FDA concluded that substantial evidence of
effectiveness has been established for LYTENAVA™ for the treatment of nAMD, and directed the Division of Ophthalmology and the Office
of Specialty Medicine to work with the Company to reach an agreement on final labeling. The Company expects to resubmit the BLA in June
2026 as a Class 1 resubmission.

The press release is attached as Exhibit 99.1
to this Current Report on Form 8-K and incorporated into this item 8.01 by reference.

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.

Description

99.1

Press Release, dated May 26, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).