Outlook Therapeutics rises as FDA agrees to review eye drug decision

Outlook Therapeutics

07/04/2026 14:01

** Shares of drugmaker Outlook Therapeutics OTLK.O rise about 10% to $0.22 premarket

** Co says it has asked the U.S. FDA to reconsider its decision not to approve its experimental eye drug ons-5010/lytenava

** Co says FDA accepted a formal dispute resolution request and will meet the company later this month

** Drug targets wet age-related macular degeneration, a common eye disease that causes vision loss due to leaking blood vessels in the retina

** Co says data from NORSE TWO and NORSE EIGHT studies show the drug is safe and effective, with no safety concerns flagged by the FDA

** Adds the drug is already approved in Europe and the UK, where commercial launches have begun

** As of last close, stock down ~87% YTD

 (Reporting by Sahil Pandey in Bengaluru)

 ((Sahil.Pandey@thomsonreuters.com))