Belite Bio, Inc, a clinical-stage biopharmaceutical drug development company, is engaged in the research and development of novel therapies targeting age-related atrophic macular degeneration and autosomal recessive stargardt diseases. The company is headquartered in San Diego, California.
| Revenue (TTM) | 0 |
| Gross Profit (TTM) | 0 |
| EBITDA | $-118.49M |
| Operating Margin | 0.00% |
| Return on Equity | -22.10% |
| Return on Assets | -15.70% |
| Revenue/Share (TTM) | $0.00 |
| Book Value | $19.29 |
| Price-to-Book | 8.76 |
| Price-to-Sales (TTM) | — |
| EV/Revenue | - |
| EV/EBITDA | -35.61 |
| Quarterly Earnings Growth (YoY) | 0.00% |
| Quarterly Revenue Growth (YoY) | 0.00% |
| Shares Outstanding | $40.27M |
| Float | $19.55M |
| % Insiders | 43.64% |
| % Institutions | 24.27% |
Volatility is currently contracting
Belite Bio, Inc. Sponsored ADR (BLTE) reached a significant support level, and could be a good pick for investors from a technical perspective. Recently, BLTE's 50-day simple moving average broke out above its 200-day moving average; this is known as a "golden cross.
SAN DIEGO, Sept. 08, 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 the submission of a New Drug Application (NDA) to the Ministry of Health, Labour, and Welfare (MHLW) in Japan for tinlarebant in 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. STGD1 affects an estimated 9,500 people in Japan alone, and there are currently no approved treatment options for the disease.
Belite Bio NASDAQ: BLTE said the U.S. Food and Drug Administration has accepted its new drug application for tinlarebant as a treatment for Stargardt disease type 1, granted the application priority review and set a Feb. 12, 2027, PDUFA date.
Belite Bio, Inc (BLTE) Discusses Prelaunch Strategy and Commercial Opportunity for Tinlarebant in Stargardt Disease Type 1 Transcript
SAN DIEGO, Sept. 01, 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 that the Company will participate in four upcoming investor conferences. Details of the presentations are as follows:
SAN DIEGO, Aug. 24, 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 that it will host a Virtual Commercial Day on Wednesday, September 2, 2026, from 8:00 – 9:30 a.m. ET.
SAN DIEGO, Aug. 21, 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 that its data will be presented at the Schweizerische Ophthalmologische Gesellschaft (SOG) Annual Congress being held on August 26-28, 2026, in Lausanne, Switzerland and the 19th Asia-Pacific Vitreo-retina Society (APVRS) Congress being held on August 28-30, 2026, in Gold Coast, Australia.
SAN DIEGO, Aug. 12, 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 its financial results for the second quarter ended June 30, 2026, and provided a business update.
Belite Bio's tinlarebant wins FDA priority review for Stargardt Disease, with a decision expected in February 2027 after positive phase III data.
SAN DIEGO, Aug. 11, 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 that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review designation of the New Drug Application (NDA) for tinlarebant for the treatment of Stargardt Disease Type 1 (STGD1). The FDA has set a Prescription Drug User Fee Act (PDUFA) date of February 12, 2027.
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