---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-111316"
form_type: "8-K"
ticker: "OTLK"
cik: "0001649989"
company_name: "Outlook Therapeutics, Inc."
filed_at: "2025-11-13T23:59:59+00:00"
generated_at: "2026-05-16T20:26:10.125473+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Outlook Therapeutics' BLA resubmission for ONS-5010; PDUFA date Dec 31, 2025

## Summary
- FDA acknowledged receipt of BLA resubmission for ONS-5010 (bevacizumab-vikg) and assigned Class 1 review.
- Class 1 review results in a two-month review period from resubmission date.
- PDUFA goal date set for December 31, 2025.

## SEC filing metadata
- accession: 0001104659-25-111316
- form_type: 8-K
- ticker: OTLK
- cik: 0001649989
- company_name: Outlook Therapeutics, Inc.
- filed_at: 2025-11-13T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1649989/000110465925111316/0001104659-25-111316-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1649989/000110465925111316/tm2531109d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-111316
- JSON: https://secwatch.observer/filing/0001104659-25-111316.json
- Plain text: https://secwatch.observer/filing/0001104659-25-111316.txt

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