Belite Bio Inc

F:D01

FDA milestone: Belite said the FDA accepted Tinlarebant’s NDA for Stargardt disease with priority review and set a PDUFA date of February 12, 2027.

Clinical readthrough: Management highlighted new Phase III DRAGON secondary data showing qAF fell about 2% at month 25 on Tinlarebant versus about a 20% increase on placebo, which they said supports the drug’s mechanism.

Cash position: The company ended the quarter with $780 million in cash, cash equivalents and U.S. treasury bills, and said it is well funded through potential commercialization and pipeline work.

Loss widened: Q2 expenses rose sharply year over year, with higher R&D and SG&A tied to milestone-related royalties, professional services, and team growth.

Outlook: Management said the U.S. review is the top priority, with Europe likely to come after FDA approval and Japan progressing in parallel under PMDA review.

Next steps: The company expects a virtual Commercial Day in September to share market sizing work, and said a pediatric study is being initiated to support use in patients younger than 12.