Belite Bio, Inc BLTE
Updated: 9 Sep 2026
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Recent News
On September 8, 2026, Belite Bio submitted a New Drug Application for tinlarebant to Japan's Ministry of Health, Labour, and Welfare under the Sakigake designation for Stargardt disease type 1. This followed the U.S. FDA's acceptance of the company's New Drug Application with Priority Review on August 11, 2026, setting a target PDUFA date of February 12, 2027.
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