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Shares of Outlook Therapeutics surged in premarket trading Tuesday after the biopharmaceutical company reported a pair of advances in its efforts to win U.S. Food and Drug Administration approval of its proposed treatment for wet age- related macular degeneration, or wet AMD.
Outlook shares, which closed Monday at 34 cents , were recently up 35% to 46 cents in premarket trading.
Outlook said it reached agreement with the FDA on a 90-day non-inferiority study of ONS-5010 that, if successful, would satisfy the agency's requirement for a second adequate and well-controlled trial to address issues the FDA raised last year when it rejected the Iselin, N.J. , company's initial application for the drug.