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

Reuters08-29
BUZZ-Outlook falls as Wainwright downgrades stock after US FDA declines to approve eye drug

** 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;))

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap
Leave a comment