---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-046014"
form_type: "8-K"
ticker: "OTLK"
cik: "0001649989"
company_name: "Outlook Therapeutics, Inc."
filed_at: "2026-04-21T23:59:59+00:00"
generated_at: "2026-05-15T05:07:08.462557+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Outlook Therapeutics completes FDA dispute resolution meeting for ONS-5010; decision expected May 2026

## Summary
- Completed Federal Dispute Resolution meeting with FDA Office of New Drugs to appeal Dec 30, 2025 Complete Response Letter for ONS-5010 BLA.
- Meeting addressed regulatory pathway for ONS-5010/LYTENAVA (bevacizumab-vikg) for wet AMD.
- Formal FDA decision expected in May 2026; company will update after receipt.
- Follows Type A meeting with Division of Ophthalmology; CEO Bob Jahr cites constructive dialogue.

## SEC filing metadata
- accession: 0001104659-26-046014
- form_type: 8-K
- ticker: OTLK
- cik: 0001649989
- company_name: Outlook Therapeutics, Inc.
- filed_at: 2026-04-21T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1649989/000110465926046014/0001104659-26-046014-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1649989/000110465926046014/tm2612353d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-046014
- JSON: https://secwatch.observer/filing/0001104659-26-046014.json
- Plain text: https://secwatch.observer/filing/0001104659-26-046014.txt

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