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

Outlook Therapeutics, Inc.

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.

item 8.01item 9.01

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.