---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-018717"
form_type: "8-K"
ticker: "OTLK"
cik: "0001649989"
company_name: "Outlook Therapeutics, Inc."
filed_at: "2025-02-28T23:59:59+00:00"
generated_at: "2026-05-25T23:32:15.778427+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Outlook Therapeutics resubmits BLA for ONS-5010 to FDA

## Summary
- 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.

## SEC filing metadata
- accession: 0001104659-25-018717
- form_type: 8-K
- ticker: OTLK
- cik: 0001649989
- company_name: Outlook Therapeutics, Inc.
- filed_at: 2025-02-28T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.85
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1649989/000110465925018717/0001104659-25-018717-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1649989/000110465925018717/tm257885d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-018717
- JSON: https://secwatch.observer/filing/0001104659-25-018717.json
- Plain text: https://secwatch.observer/filing/0001104659-25-018717.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.