Outlook falls as Wainwright downgrades stock after US FDA declines to approve eye drug

Outlook Therapeutics

29/08/2025 12:21

** Shares of drugmaker Outlook Therapeutics OTLK.O fall 6.4% to $1.02 premarket after closing 54.1% lower on Thursday, hitting record low

** U.S. FDA declined to approve co's eye drug, ONS-5010

** H.C. Wainwright downgrades stock to "neutral" from "buy," with a $1 PT

** Brokerage says it hoped FDA might show some flexibility since ONS-5010 achieved non-inferiority to Roche's ROG.S Lucentis in key trial, in which the drug missed main goal

**  Another late-stage study will be needed, H.C. Wainwright says, adding OTLK has demonstrated ONS-5010 works and another study would have high probability of success, but co's cash position complicates matters

** OTLK indicated that commercialization of the drug approved in Europe would be its focus

** "Removed all future U.S. revenues from our valuation and move to sidelines till further clarity ... assume the company will raise additional capitals to support operations," brokerage says

** "Sales in EU and UK are a modest growth driver and stock dilution is expected regardless of FDA approval," H.C. Wainwright says

 (Reporting by Puyaan Singh)

 ((Puyaan.Singh@thomsonreuters.com;))