Belite Bio lands priority review for first Stargardt treatment

The US Food and Drug Administration (FDA) has accepted and granted priority review to a New Drug Application from San Diego-based Belite Bio (Nasdaq: BLTE) for tinlarebant in Stargardt disease type 1, an inherited retinal disorder with no approved therapy anywhere. The agency has set a Prescription Drug User Fee Act target action date of February 12, 2027.

Priority review shortens the FDA's assessment window to around six months from the standard ten, and follows breakthrough therapy, fast track and rare pediatric disease designations for the candidate. Tinlarebant also holds orphan drug status in the USA, Europe, Japan and Switzerland, plus Sakigake designation in Japan.