Belite Bio files Japan NDA for tinlarebant in Stargardt disease type 1
The filing, made under Japan's Sakigake accelerated review system, arrives alongside a similar U.S. application already accepted by the FDA.
SEC filing
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Belite Bio posts Q2 2026 results as FDA reviews tinlarebant NDA under priority review
The FDA accepted Belite Bio's NDA for tinlarebant in Stargardt disease type 1 with a PDUFA date of February 12, 2027, as the company reported wider losses and new Phase 3 data.
SEC filing (2)