Outlook Therapeutics (OTLK) 8-K Summary

Date: November 3, 2025

Outlook Therapeutics, Inc. announced a material regulatory event:

• The company has resubmitted the Biologics License Application (BLA) for ONS-5010 to the U.S. Food and Drug Administration (FDA).

This BLA resubmission is the primary driver of the report, signaling the next step toward potential approval for this key asset.

The report was signed by CFO Lawrence A. Kenyon.

OTLK BLA Re-submission for ONS-5010 (LYTENAVA)

• Outlook Therapeutics (OTLK) has re-submitted its Biologics License Application (**