Tinlarebant's Significant Advancements
Tinlarebant has been granted Rare Pediatric Disease and Fast Track designations in the U.S., Pioneer Drug designation in Japan, and Orphan Drug designation in the U.S., Europe, and Japan. The Phase 3 DRAGON trial interim analysis recommended proceeding without modifications, indicating promising efficacy.
Clinical Trial Enrollment Success
The DRAGON 2 trial has enrolled 11 of the targeted 60 subjects, and the PHOENIX trial for GA has over 400 subjects enrolled, with plans to increase to 500 due to good progress.
Financial Stability
Belite Bio ended 2024 with $31.7 million in cash and $113.5 million in investments, and raised $15 million in a direct offering, maintaining a full year's cash runway.