---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-068659"
form_type: "8-K"
ticker: "OTLK"
cik: "0001649989"
company_name: "Outlook Therapeutics, Inc."
filed_at: "2026-06-01T13:15:32+00:00"
generated_at: "2026-06-01T13:16:12.934952+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Outlook Therapeutics resubmits BLA for ONS-5010 to FDA; Class 1 review, PDUFA in 60 days

## Summary
- Resubmitted BLA for ONS-5010 (bevacizumab-vikg) for neovascular AMD under Class 1 review.
- FDA OND concluded substantial evidence of effectiveness established; no additional trials required.
- PDUFA target decision date expected within 60 days of FDA receipt of resubmission.
- Resubmission follows successful appeal of December 2026 Complete Response Letter.
- If approved, ONS-5010 would be first FDA-approved ophthalmic formulation of bevacizumab.

## SEC filing metadata
- accession: 0001104659-26-068659
- form_type: 8-K
- ticker: OTLK
- cik: 0001649989
- company_name: Outlook Therapeutics, Inc.
- filed_at: 2026-06-01T13:15:32+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1649989/000110465926068659/0001104659-26-068659-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1649989/000110465926068659/tm2616461d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-068659
- JSON: https://secwatch.observer/filing/0001104659-26-068659.json
- Plain text: https://secwatch.observer/filing/0001104659-26-068659.txt

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