---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-024189"
form_type: "8-K"
ticker: "OTLK"
cik: "0001649989"
company_name: "Outlook Therapeutics, Inc."
filed_at: "2026-03-05T23:59:59+00:00"
generated_at: "2026-05-15T19:42:06.204496+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Outlook Therapeutics updates on Type A meeting with FDA for ONS-5010; no definitive resolution

## Summary
- Type A meeting held with FDA to discuss December 30, 2025 Complete Response Letter for ONS-5010 BLA.
- FDA had requested confirmatory evidence of effectiveness; no safety concerns identified by FDA.
- Company expects continued discussions to clarify agency views on confirmatory evidence.
- ONS-5010 met primary endpoints in Phase 3 NORSE TWO trial; NORSE EIGHT provided confirmatory efficacy/safety data.
- If approved, ONS-5010 would be first FDA-approved ophthalmic bevacizumab with US manufacturing supply chain.

## SEC filing metadata
- accession: 0001104659-26-024189
- form_type: 8-K
- ticker: OTLK
- cik: 0001649989
- company_name: Outlook Therapeutics, Inc.
- filed_at: 2026-03-05T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.55
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1649989/000110465926024189/0001104659-26-024189-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1649989/000110465926024189/tm268164d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-024189
- JSON: https://secwatch.observer/filing/0001104659-26-024189.json
- Plain text: https://secwatch.observer/filing/0001104659-26-024189.txt

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