Belite Bio completes rolling submission of new drug application to US FDA for tinlarebant for the treatment of Stargardt disease type 1

Belite Bio

12 June 2026 - Belite Bio today announced the completion of its rolling submission of a new drug application to the US FDA for tinlarebant. 

Tinlarebant is an investigational, once daily oral therapy for the treatment of Stargardt disease type 1, a rare, inherited retinal disease caused by mutations in the ABCA4 gene that leads to progressive and irreversible vision loss.

Read Belite Bio press release

Michael Wonder

Posted by:

Michael Wonder

Posted in:

Medicine , US , Dossier , Registration