** Shares of Outlook Therapeutics decline 82% to 92 cents before the bell
** Co says preliminary data shows its experimental drug, ONS-5010, did not achieve non-inferiority goal at week 8 in a late-stage study
** OTLK says non-inferiority goal was being evaluated after reaching an agreement with US FDA
** Last year, FDA had declined to approve OTLK's drug citing manufacturing issues and need for further clinical evidence
** Adds that data showed an improvement in vision, presence of biologic activity and a continued favorable safety profile for ONS-5010
** OTLK is testing the drug in patients with wet age-related macular degeneration, a condition that can lead to irreversible vision loss
** Co says final efficacy data from the study is expected in January 2025, plans to resubmit its marketing application to FDA in Q1 next year
** As of last close, OTLK down 38% YTD
(Reporting by Bhanvi Satija in Bengaluru)
((Bhanvi.Satija@thomsonreuters.com; Outside U.S. +91 9873062788;))
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