Belite Bio Receives the US FDA Priority Review for Tinlarebant to Treat Stargardt Disease Type 1

Shots: The US FDA has accepted & granted Priority Review to the NDA for tinlarebant for the treatment of Stargardt Disease Type 1 (STGD1), with a PDUFA target date of Feb 12, 2027 NDA was supported by the P-III (DRAGON) trial assessing tinlarebant vs PBO in STGD1 pts, showing 35.7% reduction in atrophic retinal lesion growth rate, measured as DDAF by fundus autofluorescence imaging Tinlarebant is an oral therapy designed to reduce vitamin A-derived toxins (bisretinoids) that drive retinal damage in Stargardt disease & contribute to progression of geographic atrophy, an advanced form of dry AMD Ref:  Globenewswire  |  Image: Belite Bio  |  Press Release PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com The post Belite Bio Receives the US FDA Priority Review for Tinlarebant to Treat Stargardt Disease Type 1 appeared first on PharmaShots.