04:13 AM EDT, 05/21/2025 (MT Newswires) -- Belite Bio ( BLTE ) said Wednesday the US Food and Drug Administration granted breakthrough therapy designation to its Tinlarebant drug for treating Stargardt disease.

The company said the decision is based on early results from an ongoing phase 3 trial, which showed that the drug may significantly improve over current treatment options.

The designation expedites the development and regulatory review of drugs that are intended for serious or life-threatening conditions, Belite Bio ( BLTE ) said.