8-K - Outlook Therapeutics, Inc. | StockGist

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Outlook Therapeutics, Inc. conducted a Type A meeting with the FDA on March 5, 2026, to discuss the December 30, 2025 CRL for the ONS-5010/LYTENAVA™ (bevacizumab-vikg) BLA resubmission for wet AMD treatment. The company is evaluating regulatory options to address the effectiveness issue and advance toward potential U.S. approval.

Key Takeaways

1Type A meeting held with FDA on March 5, 2026, to discuss CRL dated December 30, 2025 for ONS-5010/LYTENAVA™ BLA

2CRL identified outstanding issue on substantial evidence of effectiveness

3NORSE TWO Phase 3 trial met primary and key secondary endpoints for visual acuity improvements

4NORSE EIGHT provided confirmatory evidence of efficacy and safety

5ONS-5010/LYTENAVA™ approved in EU and UK for wet AMD; investigational in U.S.

6Company committed to engaging FDA for alignment on confirmatory evidence and efficient approval pathway

Current Report Details

Event Type

Other Event

Disclosure

Voluntary

Variant

8-K

Items Reported

8.01

by reference. Item 9.01. Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press Release, dated March 5, 2026 104 Cover Page Interact

Other Event

Exhibits (2)

8-K

FORM 8-K

99.1

EXHIBIT 99.1