Belite Bio Reports $772.6M Cash, Targets Q2 2026 NDA and Q1 2027 Launch
Belite Bio ended fiscal 2025 with $772.6 million in cash after multiple financings and expects to submit a rolling NDA for tinlarebant in Q2 2026 with U.S. launch by Q1 2027. Its Phase III DRAGON trial showed a 36% reduction in atrophy lesion growth measured by DDAF.
1. Phase III DRAGON Efficacy Results
Belite Bio’s pivotal DRAGON trial in Stargardt disease met its primary efficacy endpoint, demonstrating a 36% reduction in lesion atrophy growth measured by DDAF versus placebo.
2. NDA Filing and U.S. Launch Timeline
The company remains on track to submit a rolling New Drug Application for tinlarebant in Q2 2026 and targets a U.S. commercial launch by Q1 2027 with an initial 25–30 person field organization.
3. Cash Position and Commercial Build-Out
Belite Bio closed fiscal 2025 with $772.6 million in cash following multiple financings, and it forecasts $150 million for pipeline R&D plus $150–200 million for commercialization over the next three years.
4. DRAGON II Enrollment and Japan Focus
Enrollment in the DRAGON II trial reached 72 subjects as of late February and is targeted at 72–75 participants for Japan only, while the PHOENIX geographic atrophy study is fully enrolled at 430 subjects.