Belite Bio Inc. (BLTE), a clinical-stage drug development company, on Tuesday announced initiation of a rolling new drug application (NDA) submission to the U.S. Food and Drug Administration (FDA), for Tinlarebant in treating Stargardt disease.
Stargardt disease type 1 (STGD1) is a rare, inherited retinal disorder caused by a mutation in the ABCA4 gene. The progressive disease often begins in adolescence, and is marked by the accumulation of vitamin A-based toxins (bisretinoids), leading to retinal disintegration.
Tinlarebant (LBS-008) was developed for the treatment of STGD1 by reducing and maintaining levels of serum retinol-binding protein 4 (RBP4), the sole carrier protein from the liver to the eye. The drug thus regulates the formation of bisretinoids, preventing progression of the disease. Results from the Phase 3 DRAGON trial on adolescents with STGD1 will contribute to the NDA submission.
Tinlarebant was previously granted a breakthrough therapy, fast track, rare pediatric disease, and orphan drug designation in the U.S. Europe and Japan, in addition to a Sakigake designation in Japan. It is currently being evaluated in the Phase 2/3 DRAGON II trial for adolescent subjects with STGD1, and in the Phase 3 PHOENIX trial for treating geographic atrophy (GA) in age-related macular degeneration.
The company expects to complete the rolling NDA submission by the second quarter of 2026.
BLTE closed Tuesday at $165.23, down 0.12%.
For comments and feedback contact: editorial@rttnews.com
Business News
June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.