---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-074346"
form_type: "8-K"
ticker: "OTLK"
cik: "0001649989"
company_name: "Outlook Therapeutics, Inc."
filed_at: "2026-06-16T12:46:01+00:00"
generated_at: "2026-06-16T12:50:07.128019+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA accepts resubmitted BLA for Outlook's ONS-5010; PDUFA date July 29, 2026

## Summary
- FDA acknowledged receipt of resubmitted BLA for ONS-5010 (bevacizumab-vikg) to treat wet AMD.
- Class 1 review with 60-day review period; PDUFA target action date set for July 29, 2026.
- If approved, ONS-5010 would be first FDA-approved ophthalmic bevacizumab with standardized manufacturing & labeling.
- Company has initiated pre-launch activities in anticipation of potential BLA approval.

## SEC filing metadata
- accession: 0001104659-26-074346
- form_type: 8-K
- ticker: OTLK
- cik: 0001649989
- company_name: Outlook Therapeutics, Inc.
- filed_at: 2026-06-16T12:46:01+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1649989/000110465926074346/0001104659-26-074346-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1649989/000110465926074346/tm2618010d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-074346
- JSON: https://secwatch.observer/filing/0001104659-26-074346.json
- Plain text: https://secwatch.observer/filing/0001104659-26-074346.txt

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