---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-094558"
form_type: "8-K"
ticker: "OTLK"
cik: "0001649989"
company_name: "Outlook Therapeutics, Inc."
filed_at: "2025-09-29T23:59:59+00:00"
generated_at: "2026-05-17T05:24:34.240801+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Outlook Therapeutics completes FDA Type A meeting for ONS-5010 BLA; plans resubmission in 2025

## Summary
- Type A meeting with FDA discussed August 27, 2025 CRL for ONS-5010 BLA (bevacizumab for wet AMD).
- Company expects to resubmit BLA before end of calendar year 2025 after reviewing FDA feedback.
- CEO Bob Jahr stated productive discussion; written minutes still pending.

## SEC filing metadata
- accession: 0001104659-25-094558
- form_type: 8-K
- ticker: OTLK
- cik: 0001649989
- company_name: Outlook Therapeutics, Inc.
- filed_at: 2025-09-29T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1649989/000110465925094558/0001104659-25-094558-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1649989/000110465925094558/tm2527376d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-094558
- JSON: https://secwatch.observer/filing/0001104659-25-094558.json
- Plain text: https://secwatch.observer/filing/0001104659-25-094558.txt

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