Outlook hits record low after US FDA declines to approve eye drug

Outlook Therapeutics

28/08/2025 18:31

Updates

** Shares of Outlook Therapeutics OTLK.O slump as much as 66.8% to an all-time low of 79 cents

 ** Stock set for its worst day in more than 9 months, if losses hold

** U.S. FDA declines to approve company's drug for a type of eye condition called wet age-related macular degeneration (wet AMD) that causes blurred vision

** FDA's letter included only one deficiency: "A lack of substantial evidence of effectiveness" - OTLK

** Intend to meet with FDA officials to receive additional clarity on their requirements, OTLK CEO says, adding the regulator did not specify whether further clinical trials would be necessary

** "It does represent a significant setback for the company" - Chardan Capital Markets analyst Daniil Gataulin

** Including session moves, stock down 41% YTD

(Reporting by Puyaan Singh and Kamal Choudhury)

((Puyaan.Singh@thomsonreuters.com;))