Belite Bio reported a Phase 3 victory for tinlarebant in adolescents with Stargardt disease, meeting the trial’s primary endpoint and clearing a major regulatory hurdle. The result strengthens Belite’s plan to add the United States to its list of filing jurisdictions next year and brings the company closer to an FDA submission. Tinlarebant targets a rare genetic macular degeneration and the Phase 3 outcome provides the statistical evidence Belite needs to pursue approval. The company will compile the global dataset for regulatory dossiers and discuss next steps with health authorities.