Outlook Therapeutics Shares Surge After FDA Accepts Resubmitted Wet AMD Application
By Anvee Bhutani
Outlook Therapeutics shares climbed Tuesday after the company said the U.S. Food and Drug Administration accepted its resubmitted biologics license application for ONS-5010/LYTENAVA as a treatment for age-related macular degeneration, a condition in which retina damage results in vision loss.
Shares of the biopharmaceutical company were up around 20% at $1.39. The stock has more than quadrupled in the last month.
The FDA classified the resubmission as a class 1 review and set a Prescription Drug User Fee Act, or PDUFA, target action date of July 29.
If approved, the company said Lytenava would become the first FDA-approved ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration. Outlook Therapeutics said it has begun prelaunch activities ahead of the FDA's decision.
Write to Anvee Bhutani at anvee.bhutani@wsj.com
(END) Dow Jones Newswires
June 16, 2026 10:35 ET (14:35 GMT)
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