Outlook Therapeutics Shares Surge After FDA Accepts Resubmitted Wet AMD Application

Dow Jones06-16

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 10:20 ET (14:20 GMT)

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