Outlook Therapeutics slumps as eye disease drug fails to meet key goal in study

Outlook Therapeutics

27/11/2024 12:18

** Shares of Outlook Therapeutics  OTLK.O  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;))