BLTE News & Events

Belite Bio sees FY25 adjusted EPS ($1.15) vs. ($89c) last year

"2025 marked a defining year for Belite, highlighted by positive topline results from our pivotal Phase 3 DRAGON trial, establishing tinlarebant as a potential first-in-class therapy for Stargardt disease," said Dr. Tom Lin, Chairman and CEO of Belite Bio. "Combined with the completion of our $402 million public offering, we believe the Company is well positioned for the next phase of execution, and we remain on track to submit an NDA to the FDA in the second quarter of 2026 as we advance toward our goal of bringing the first approved treatment for Stargardt disease to people living with this debilitating disease."

Belite Bio announced the completion of enrollment of 60 subjects, including 15 Japanese subjects, in the Phase 2/3 DRAGON II clinical trial evaluating tinlarebant for the treatment of Stargardt disease type 1. DRAGON II clinical trial is a global, 24-month, randomized, double-masked, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of tinlarebant in adolescent patients with STGD1. The trial had a targeted enrollment of 60 adolescent subjects aged 12 to 20 years old across Japan, the United States, and the United Kingdom, with participants randomized 1:1 to receive either tinlarebant or placebo.