Outlook Therapeutics collapses as its eye disease drug fails to meet main study goal – 11/27/2024 at 1:18 p.m.

((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