---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-123554"
form_type: "8-K"
ticker: "OTLK"
cik: "0001649989"
company_name: "Outlook Therapeutics, Inc."
filed_at: "2024-11-27T23:59:59+00:00"
generated_at: "2026-05-29T14:34:40.130281+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Outlook Therapeutics' ONS-5010 misses key endpoint in NORSE EIGHT trial; BLA resubmission planned Q1 2025

## Summary
- ONS-5010 did not meet non-inferiority endpoint at week 8 vs ranibizumab (difference -2.257 BCVA letters, margin -3.5).
- Mean BCVA improvement: ONS-5010 +4.2 letters, ranibizumab +6.3 letters (p=0.0863).
- Favorable safety profile: no retinal vasculitis, ocular AE rates comparable to ranibizumab.
- Final month 3 data expected Jan 2025; BLA resubmission to FDA in calendar Q1 2025.
- EU/UK marketing authorization already granted; launch in UK and Germany planned for 2025.

## SEC filing metadata
- accession: 0001104659-24-123554
- form_type: 8-K
- ticker: OTLK
- cik: 0001649989
- company_name: Outlook Therapeutics, Inc.
- filed_at: 2024-11-27T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- 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/1649989/000110465924123554/0001104659-24-123554-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1649989/000110465924123554/tm2429443d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-123554
- JSON: https://secwatch.observer/filing/0001104659-24-123554.json
- Plain text: https://secwatch.observer/filing/0001104659-24-123554.txt

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