Belite Bio (BLTE) said Monday its lead product candidate tinlarebant has been granted orphan drug status by the Swiss Agency for Therapeutic Products to treat Stargardt disease, a rare retinal disorder.

The company said it has recently started a rolling submission of a new drug application with the US Food and Drug Administration, which it expects to complete in Q2.

Tinlarebant has been given breakthrough therapy, fast track and rare pediatric disease designations in the US, as well as orphan drug designation in the US, Europe, and Japan, Belite Bio said.