---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-013470"
form_type: "8-K"
ticker: "OTLK"
cik: "0001649989"
company_name: "Outlook Therapeutics, Inc."
filed_at: "2026-02-11T23:59:59+00:00"
generated_at: "2026-05-16T03:19:49.117420+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Outlook Therapeutics requests Type A FDA meeting after CRL for wet AMD drug ONS-5010

## Summary
- CRL dated Dec 30, 2025 cited lack of substantial evidence; company believes it contradicts alignment from Sept 2025 meeting.
- Phase 3 NORSE TWO met primary endpoint (15-letter gain at 12 months); NORSE EIGHT missed primary at 8 weeks.
- ONS-5010/LYTENAVA is already approved and commercially available in EU and UK for wet AMD.
- FDA has not raised safety concerns; company plans to pursue resolution via Type A meeting.

## SEC filing metadata
- accession: 0001104659-26-013470
- form_type: 8-K
- ticker: OTLK
- cik: 0001649989
- company_name: Outlook Therapeutics, Inc.
- filed_at: 2026-02-11T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1649989/000110465926013470/0001104659-26-013470-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1649989/000110465926013470/tm265994d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-013470
- JSON: https://secwatch.observer/filing/0001104659-26-013470.json
- Plain text: https://secwatch.observer/filing/0001104659-26-013470.txt

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