Shares of Belite Bio, Inc (BLTE) gained over 15% on Tuesday morning after the company's Stargardt Disease Treatment received Fast-Track Designation from the U.S. Food and Drug Administration.
BLTE is currently trading at $10.29, up $1.42 or 15.98%, on the Nasdaq. The stock has traded between $8.80 and $17.50 in the past 52 week period.
Belite Bio, a clinical-stage biopharmaceutical drug development company, engages in the research and development of novel therapeutics targeting atrophic age-related macular degeneration and autosomal recessive stargardt diseases.
Belite Bio announced that LBS-008, an orally administered tablet, has been granted Fast Track Designation by the FDA for the treatment of Stargardt disease. This decision was based upon FDA's review of non-clinical data and preliminary clinical data from studies of LBS-008.
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.
"We are delighted that LBS-008 has received FDA Fast Track Designation. STGD1 is a terrible retinal disease with the potential to severely affect the vision of afflicted patients and there are currently no approved treatments," said Dr. Tom Lin, the Company's Chairman and CEO. "At present, we are conducting a Phase 3 clinical trial in order to bring to market a treatment that will halt or slow the progression of STGD1. Additionally, we are evaluating our plan to launch a Phase 2/3 trial in Dry AMD in 2022. Dry AMD is a disease which shares a similar underlying pathophysiology with STGD1 and is a leading cause of central vision loss in people over 50."
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