Belite Bio, Inc
tinlarebant
Stargardt disease type 1
Resolved
7days ago
FDA decision · ~ Jun 30, 2026 estimated
What's at stake
The FDA's approval decision on tinlarebant for Stargardt disease type 1 is due ~ Jun 30, 2026. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
Primary source
· SEC 6-K
verified 13h ago
“Initiated a rolling NDA submission under Breakthrough Therapy Designation with the FDA for tinlarebant in STGD1 in April 2026. The NDA submission is expected to be completed in the second quarter of 2026”