Belite Bio at H.C. Wainwright conference: tinlarebant nears FDA review
Belite Bio, at the H.C. Wainwright 28th Annual Global Investment Conference on 15 September 2026, announced the progression of its oral drug Tinlarebant for Stargardt disease, with the program nearing an FDA decision. The company presented a comprehensive package to the regulatory body, incorporating natural history data from the ProgStar study and fellow-eye analysis from the DRAGON trial.
Tinlarebant demonstrated a 35.7% reduction in DDAF lesion growth over 24 months compared to placebo, and the company reported a positive safety profile with only four dropouts among 104 patients. They also highlighted the drug's potential to prevent bisretinoid buildup in the retina, backed by quantitative autofluorescence data.
Belite Bio's CFO, Hao-Yuan Chuang, stated that the company's strong liquidity position, with $780 million in cash and $450 million expected in operating costs over three years, provides financial flexibility for commercialization.
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