((Automated translation by Reuters, please see disclaimer https://bit.ly/rtrsauto))
November 27 – ** Shares of Outlook Therapeutics OTLK.O fall 82% to 92 cents before the stock market closes
**Company says preliminary data shows its investigational drug, ONS-5010, failed to meet non-inferiority goal at week 8 in late-stage study
**OTLK states that the non-inferiority objective was under evaluation after reaching an agreement with the US FDA
** Last year, the FDA declined to approve OTLK’s drug citing manufacturing problems and the need for additional clinical evidence
**Data showed improvement in vision, presence of biological activity and a favorable safety profile for ONS-5010
**OTLK is testing the drug in patients with age-related macular degeneration, a disease that can lead to irreversible vision loss
**The company says final study efficacy data is expected in January 2025, and plans to resubmit its marketing application to the FDA in the first quarter of next year
** At the last close, OTLK was down 38% since the beginning of the year
Canada
