OUTLOOK THERAPEUTICS INC is trading 23.7% up today at $1.44 after announcing that the FDA accepted its resubmitted Biologics License Application (BLA) for ONS-5010 to treat wet AMD.

  • The FDA has assigned a PDUFA goal date of July 29, 2025, providing a clear regulatory timeline for the company's lead ophthalmic biologic.
  • Investors are reacting to the renewed path toward potential approval, driving strong upside momentum that significantly outperforms the mixed broader market.
  • ONS-5010, if approved, would be the first on-label ophthalmic formulation of bevacizumab for retinal indications.