regulatory
confidence high
sentiment positive
materiality 0.85
Outlook Therapeutics resubmits BLA for ONS-5010 to FDA; Class 1 review, PDUFA in 60 days
Outlook Therapeutics, Inc.
- Resubmitted BLA for ONS-5010 (bevacizumab-vikg) for neovascular AMD under Class 1 review.
- FDA OND concluded substantial evidence of effectiveness established; no additional trials required.
- PDUFA target decision date expected within 60 days of FDA receipt of resubmission.
- Resubmission follows successful appeal of December 2026 Complete Response Letter.
- If approved, ONS-5010 would be first FDA-approved ophthalmic formulation of bevacizumab.