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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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.