Outlook Therapeutics plunges after FDA rejects eye drug for third time

Outlook Therapeutics

02/01/2026 11:13

** Shares of Outlook Therapeutics OTLK.O plunge 59.6% to 64 cents premarket

** U.S. FDA declines to approve co's Lytenava for wet age-related macular degeneration, citing lack of confirmatory evidence of efficacy

** Decision marks third rejection after earlier refusals in 2023 and Aug 2025

** Lytenava, an eye disease-specific adaptation of bevacizumab, failed to match Roche's ROG.S Lucentis in key trial

** Drug already approved in EU and UK; FDA has not indicated what type of confirmatory evidence would be acceptable

** OTLK down 16.4% in 2025

 (Reporting by Tharuniyaa Lakshmi in Bengaluru)

 ((tharuniyaa@thomsonreuters.com))