BLTE | Market Cap: $5.8B (07/13/26)
Industry:
Pharma & Biotech
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DESCRIPTION

Belite Bio is a clinical-stage biopharmaceutical company developing oral treatments for degenerative retinal diseases. Belite's lead and only clinical-stage asset is tinlarebant, a once-daily oral pill that blocks RBP4, the protein that delivers vitamin A to the eye, thereby slowing the buildup of toxic byproducts that destroy retinal cells in patients with Stargardt disease type 1 (STGD1) and geographic atrophy (GA), the advanced dry form of age-related macular degeneration. Both diseases cause progressive, irreversible central vision loss; there are currently no approved treatments for STGD1, and existing GA treatments require monthly eye injections. Tinlarebant's Phase 3 DRAGON trial in adolescent STGD1 patients met its primary endpoint with a 35.7% reduction in lesion growth vs. placebo, and the FDA has granted tinlarebant Breakthrough Therapy Designation. Belite plans to file an NDA in Q2 2026 targeting a label for all STGD1 patients aged 12 and older, with a U.S. commercial launch planned for Q1 2027 using a specialty sales force of 25–30 reps. A separate Phase 3 trial in GA (PHOENIX) is ongoing, with interim data expected in the second half of 2026. Belite holds an exclusive worldwide license from Columbia University covering over 400 RBP4 antagonists. The company has no product revenue today and funds operations through equity capital, closing FY25 with approximately $773M in cash.

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