Posted by Michael Wonder on 25 Apr 2026
Belite Bio initiates rolling submission of new drug application to the US FDA for tinlarebant for the treatment of Stargardt disease
21 April 2026 - Belite expects to complete the new drug application submission in the second quarter of 2026.
Belite Bio today announced that it has initiated a rolling submission of an new drug application to the US FDA for tinlarebant, an investigational novel oral therapy for the treatment of Stargardt disease type 1, a rare, inherited retinal disorder caused by mutations in the ABCA4 gene.
