---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-25-004606"
form_type: "8-K"
ticker: "OTLK"
cik: "0001649989"
company_name: "Outlook Therapeutics, Inc."
filed_at: "2025-04-08T23:59:59+00:00"
generated_at: "2026-05-23T19:03:02.198563+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# FDA accepts resubmission of OTLK's BLA for ONS-5010; PDUFA date set for August 27, 2025

## Summary
- FDA acknowledged receipt of resubmission of BLA for ONS-5010 (bevacizumab-vikg).
- FDA designated the BLA as a Class 2 review with a six-month review period.
- PDUFA goal date for the BLA is August 27, 2025.

## SEC filing metadata
- accession: 0001558370-25-004606
- form_type: 8-K
- ticker: OTLK
- cik: 0001649989
- company_name: Outlook Therapeutics, Inc.
- filed_at: 2025-04-08T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.6
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1649989/000155837025004606/0001558370-25-004606-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1649989/000155837025004606/otlk-20250408x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-25-004606
- JSON: https://secwatch.observer/filing/0001558370-25-004606.json
- Plain text: https://secwatch.observer/filing/0001558370-25-004606.txt

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