Belite Bio Announces Multi-Market Submission of Marketing Authorization Applications Via the Access Consortium Pathway for Tinlarebant for the Treatment of Stargardt Disease Type 1
Key Highlights
- ➤Belite Bio submitted MAAs in Singapore, the United Kingdom, and Switzerland
- ➤Tinlarebant could become the first approved STGD1 treatment in all three countries
- ➤U.S. NDA has Priority Review and a February 12, 2027 PDUFA target date
- ➤Japan NDA uses the SAKIGAKE Designation System for accelerated review
- ➤Phase 3 DRAGON trial met its primary endpoint in STGD1
Expert Statements
Tom Lin, Chairman and Chief Executive Officer of Belite Bio
“These submissions are an important step toward making tinlarebant available globally to people living with STGD1. Filing through the Access Consortium allows us to pursue authorization across three additional countries in parallel. We are confident in our robust data showing tinlarebant’s ability to slow the growth rate of retinal lesions compared to placebo, and we look forward to working with each agency through their reviews.”
Tom Lin, Chairman and Chief Executive Officer of Belite Bio
“If approved, tinlarebant would become the first therapy approved for STGD1 in Singapore, the United Kingdom, and Switzerland. I want to thank my colleagues across the organization for their contributions, as well as the patients, their families, and the healthcare professionals who made these submissions possible.”
* If approved, tinlarebant would be the first-ever approved treatment for Stargardt Disease Type 1 in Singapore, United Kingdom, and Switzerland * Access pathway submission combined with accepted new drug applications in the U.S. (Prescription Drug User Fee Act target action date of February 12, 2027) and in Japan, further advance the Company’s goal to bring tinlarebant to Stargardt disease type 1 patients around the world SAN DIEGO, Oct. 14, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio(®)” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced Marketing Authorization Application (MAA) submissions to the regulatory authorities in Singapore, the United Kingdom, and Switzerland for tinlarebant in the treatment of Stargardt disease type 1 (STGD1). Tinlarebant is an investigational, once-daily oral therapy for the treatment of STGD1, a rare, inherited retinal disease caused by mutations in the ABCA4 gene that leads to progressive and irreversible vision loss. There are currently no approved treatment options for the disease in Singapore, the United Kingdom, or Switzerland.
Get started
Create a free account to read the full story.