Shares of Outlook Therapeutics, Inc. (OTLK) are climbing about 38 percent in Tuesday morning trading after the company announced that the U.S. FDA has granted its appeal following completion of the Formal Dispute Resolution process for ONS-5010/LYTENAVA, its investigational therapy for neovascular age-related macular degeneration (nAMD).
The company's shares are currently trading at $0.4251 on the Nasdaq, up 38.08 percent. The stock opened at $0.4652 and has climbed as high as $0.4653 so far in today's session. Over the past year, it has traded in a range of $0.1610 to $3.3900.
CEO Bob Jahr said the decision "provides a clear path forward toward U.S. approval." The company plans to resubmit its Biologics License Application in June 2026, with a Class 1 resubmission expected to carry a PDUFA decision within 60 days.
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May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.