Belite Bio Announces FDA Granting of Breakthrough Therapy Designation for Tinlarebant for the Treatment of Stargardt Disease

Belite Bio Announces FDA Granting of Breakthrough Therapy Designation for Tinlarebant for the Treatment of Stargardt Disease

Designation is based on the pivotal Phase 3 DRAGON trial interim analysis results demonstrating Tinlarebant’s efficacy and favorable safety profileTrial...

FDA grants Breakthrough Therapy Designation for Tinlarebant

The designation is based off previously reported phase 3 data from the ongoing DRAGON trial.

#Belite Bio Secures FDA Breakthrough Therapy Designation for Tinlarebant in Treating Stargardt Disease,

Belite Bio's Breakthrough in the Treatment of Stargardt Disease Belite Bio Inc. (NASDAQ: BLTE), a clinical-stage biopharmaceutical company, has recently been thrust into the spotlight with the announcement that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its drug candidate, Tinlarebant, for the treatment of Stargardt Disease (STGD1). This designation is significant as it not only accelerates the d…