Outlook Therapeutics resubmits BLA for ONS-5010 to FDA

Outlook Therapeutics, Inc.

Resubmitted Biologics License Application for ONS-5010 to FDA on February 28, 2025.
No details on resubmission content, prior FDA actions, or expected review timeline provided.
Resubmission marks a key regulatory step for the company's sole pipeline candidate.

item 8.01

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accession 0001104659-25-018717

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This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.