Belite Bio Inc. shares rose 47% to $13.05 after the company said its LBS-008, an orally administered tablet, has been granted fast-track designation by the Food and Drug Administration for the treatment of Stargardt disease, or STGD1, a retinal disease with the potential to severely affect vision.
The company said the decision was based upon the FDA's review of nonclinical data and preliminary clinical data from studies of LBS-008.
The stock hit its 52-week low of $8.80 on Monday, when it closed down 16%.
Belite said it is conducting a Phase 3 clinical trial to bring to market a treatment that will halt or slow the progression of STGD1. It is evaluating a plan to launch a Phase 2/3 trial in atrophic age-related macular degeneration in 2022, it said.
The company said it expects the next near-term data readout in its STGD1 Phase 2 trial in the last quarter of this year when all subjects have completed 12 months of treatment.
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