---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-065992"
form_type: "8-K"
ticker: "OTLK"
cik: "0001649989"
company_name: "Outlook Therapeutics, Inc."
filed_at: "2026-05-26T11:15:41+00:00"
generated_at: "2026-05-26T11:20:07.299444+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA grants Outlook Therapeutics appeal; BLA resubmission planned for June 2026

## Summary
- FDA concluded substantial evidence of effectiveness for LYTENAVA (bevacizumab-vikg) for nAMD after FDR appeal.
- Company will resubmit BLA as Class 1 in June 2026; PDUFA decision expected within 60 days.
- Appeal resolves December 30, 2025 Complete Response Letter; FDA directs final labeling discussions.
- NORSE TWO trial results plus confirmatory data from NORSE EIGHT and other evidence supported effectiveness.

## SEC filing metadata
- accession: 0001104659-26-065992
- form_type: 8-K
- ticker: OTLK
- cik: 0001649989
- company_name: Outlook Therapeutics, Inc.
- filed_at: 2026-05-26T11:15:41+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1649989/000110465926065992/0001104659-26-065992-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1649989/000110465926065992/tm2615583d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-065992
- JSON: https://secwatch.observer/filing/0001104659-26-065992.json
- Plain text: https://secwatch.observer/filing/0001104659-26-065992.txt

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