Belite Bio (BLTE) Stock Overview
A clinical stage biopharmaceutical drug development company, engages in the research and development of novel therapeutics with unmet medical needs in the United States. More details
| Snowflake Score | |
|---|---|
| Valuation | 3/6 |
| Future Growth | 5/6 |
| Past Performance | 0/6 |
| Financial Health | 5/6 |
| Dividends | 0/6 |
BLTE Community Fair Values
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Analyst Price Targets
Belite Bio, Inc Competitors
Price History & Performance
| Historical stock prices | |
|---|---|
| Current Share Price | US$173.40 |
| 52 Week High | US$200.00 |
| 52 Week Low | US$68.21 |
| Beta | -1.24 |
| 1 Month Change | 7.66% |
| 3 Month Change | 19.51% |
| 1 Year Change | 143.23% |
| 3 Year Change | 454.53% |
| 5 Year Change | n/a |
| Change since IPO | 1,537.39% |
Recent News & Updates
New Narrative • Sep 19
Priority Review For Rare Retinal Disease Will Drive Long-Term Upside Potential
Catalysts About Belite Bio Belite Bio is a clinical stage biopharmaceutical company focused on developing treatments for retinal degenerative diseases such as Stargardt disease and geographic atrophy. What are the underlying business or industry changes driving this perspective?Seeking Alpha • Sep 09
Belite Bio On Track For A Potential Blockbuster Launch In 2027
Summary Belite Bio has stayed on track toward a potential blockbuster launch of tinlarebant in 2027, with FDA approval for STGD1 expected in February 2027. The FDA's acceptance of the NDA and priority review status reduce (but don't eliminate) regulatory risks, while label scope and pricing remain key unknowns. Management is planning to launch tinlarebant with a modest 50-rep sales force, but driving awareness among patients and general optometrists and ophthalmologists will be key over the long term. My base-case assumptions lead me to a fair value between $205 and $220, but a clean FDA approval with generous labeling and pricing meaningfully above $350K/year could drive significant upside. With $780M in cash and manageable burn, BLTE is a 'strong hold'—I would revisit it on a sentiment-driven pullback. Read the full article on Seeking AlphaRecent updates
New Narrative • Sep 19
Priority Review For Rare Retinal Disease Will Drive Long-Term Upside Potential
Catalysts About Belite Bio Belite Bio is a clinical stage biopharmaceutical company focused on developing treatments for retinal degenerative diseases such as Stargardt disease and geographic atrophy. What are the underlying business or industry changes driving this perspective?Seeking Alpha • Sep 09
Belite Bio On Track For A Potential Blockbuster Launch In 2027
Summary Belite Bio has stayed on track toward a potential blockbuster launch of tinlarebant in 2027, with FDA approval for STGD1 expected in February 2027. The FDA's acceptance of the NDA and priority review status reduce (but don't eliminate) regulatory risks, while label scope and pricing remain key unknowns. Management is planning to launch tinlarebant with a modest 50-rep sales force, but driving awareness among patients and general optometrists and ophthalmologists will be key over the long term. My base-case assumptions lead me to a fair value between $205 and $220, but a clean FDA approval with generous labeling and pricing meaningfully above $350K/year could drive significant upside. With $780M in cash and manageable burn, BLTE is a 'strong hold'—I would revisit it on a sentiment-driven pullback. Read the full article on Seeking Alpha
Narrative Update • Sep 04
BLTE: Priority Review For Stargardt Therapy Will Shape Multi Blockbuster Potential
Belite Bio's analyst price target has moved higher from $211.50 to about $223.89 as analysts factor in recent target increases from several firms and renewed enthusiasm around tinlarebant following the FDA's acceptance of the NDA submission and long term U.S. sales potential modeled in recent research. Analyst Commentary Recent Street research on Belite Bio focuses heavily on the potential of tinlarebant, the valuation impact of higher long term sales assumptions and the execution risk around regulatory and commercial milestones in the U.S. Bullish Takeaways Bullish analysts highlight tinlarebant as a first therapeutic candidate to show a statistically significant reduction in lesion growth for Stargardt disease, which they see as a core driver for Belite Bio's long term revenue potential.
New Narrative • Sep 04
Single-Drug Dependence And Delayed Trials Will Shape Future Retinal Therapy Prospects
Catalysts About Belite Bio Belite Bio is a clinical stage biopharmaceutical company focused on therapies for retinal diseases such as Stargardt disease and geographic atrophy. What are the underlying business or industry changes driving this perspective?Analysis Article • Jun 17
Belite Bio (BLTE) Stock Could Be 35% Undervalued After Tinlarebant NDA Submission
Why Belite Bio Stock Is Back in Focus After Tinlarebant NDA Milestone Belite Bio (BLTE) is drawing attention after completing its rolling New Drug Application submission to the FDA for tinlarebant, an oral therapy candidate for Stargardt disease type 1, a rare inherited retinal condition with no approved treatments. See our latest analysis for Belite Bio. Belite Bio’s latest regulatory milestone comes after a period where momentum has cooled in the share price, with the stock down 14.35% on a...New Narrative • Mar 05
Oral Retinal Therapy Potential Will Reshape Long Term Outlook For This Pre Revenue Biotech
Catalysts About Belite Bio Belite Bio is a clinical stage biopharmaceutical company focused on oral therapies for retinal and liver diseases. What are the underlying business or industry changes driving this perspective?Seeking Alpha • Oct 03
Belite Bio down 21% after disappointing mid-stage results of rare eye disease candidate
Belite Bio (NASDAQ:BLTE) is off 21% in Monday trading after reporting disappointing phase 2 results on tinlarebant for adolescent Stargardt Disease, a rare eye disease characterized by fatty material build-up in the macula. While the company presented the results in a positive light in a Friday evening news release -- a majority of the subjects showed stabilization of visual acuity in at least one eye and no atrophic lesion in 12 of 13 subjects over 12 months of treatment, investors seem less than impressed. Data also showed that fundus autofluorescence imaging indicated no autofluorescence expansion in 7 of 13 participants and 9 of 13 subjects demonstrated a stabilization or improvement in visual acuity. The trial is slated to last for two years.Seeking Alpha • Sep 16
Belite Bio receives approval of begin LBS-008 phase 3 trial in China
Belite Bio (NASDAQ:BLTE) said on Friday it had received approval from the National Medical Products Administration of China to begin the Phase 3 trial of its drug, LBS-008, in adolescent with a rare type of eye disease called Stargardt disease STGD1. A 2-year Phase 2 trial in adolescent STGD1 and a global Phase 3 trial in adolescent STGD1 are ongoing. A Phase 3 trial, dubbed dragon, to Evaluate the Safety and Efficacy of LBS-008 in adolescent subjects had begun in the U.S., the United Kingdom, Germany, Belgium, Switzerland, Hong Kong, Taiwan, and Australia, with several patients already enrolled.Seeking Alpha • Aug 22
Belite Bio adds 15% as pivotal trial for lead asset starts in U.S.
Recently IPO’d Belite Bio, Inc (NASDAQ:BLTE) ended a four-day selloff on Monday to climb ~15% after the biopharma company announced the enrollments of its pivotal U.S. Phase 3 clinical trial for lead candidate LBS-008 in patients with eye disorder Stargardt Disease (STGD1). STGD1 has no FDA-approved therapies, and it is the commonest inherited retinal dystrophy that can lead to blurring and/or loss of central vision. LBS-008, an orally administered tablet, is currently undergoing a 2-year Phase 2 trial and a 2-year Phase 3 (DRAGON) trial involving adolescents with STGD1. The company plans to enroll about 60 subjects in the Phase 3 trial which is currently underway in the U.S., U.K., Germany, Belgium, Switzerland, Hong Kong, Taiwan, and Australia. In Q4 2022, BLTE expects to launch a Phase 2/3 trial designed to evaluate the potential of LBS-008 in non-neovascular age-related macular degeneration (Dry AMD), another eye condition with no FDA-approved therapies. Read more about BLTE’s upcoming milestones.Seeking Alpha • Aug 12
Belite Bio GAAP EPS of -$0.23 beats by $0.05
Belite Bio press release (NASDAQ:BLTE): 1H GAAP EPS of -$0.23 beats by $0.05. As of June 30, 2022, the company had $48.7M in cash.Seeking Alpha • Jul 19
Belite seeks FDA nod to proceed with phase 3 trial of genetic eye disease treatment
Belite Bio (NASDAQ:BLTE) on Tuesday said it had submitted an investigational new drug application to the U.S. FDA to proceed with its phase 3 trial of its oral tablet LBS-008 for the treatment of Stargardt disease (STGD1). STGD1 is a rare genetic eye disease that is characterized by fatty material build up on the macula. Belite Bio (BLTE) said it is currently conducting a 2-year phase 2 trial and a 2-year phase 3 trial of LBS-008 in adolescent STGD1 subjects. The company said its phase 3 trial, called DRAGON, had already been approved for enrollment in the UK, Switzerland, Hong Kong, Taiwan and Australia. U.S.-listed shares of BLTE earlier closed +5.3% at $43.70.Shareholder Returns
| BLTE | US Pharmaceuticals | US Market | |
|---|---|---|---|
| 7D | 0.2% | 0.9% | -0.1% |
| 1Y | 143.2% | 48.1% | 11.9% |
Return vs Industry: BLTE exceeded the US Pharmaceuticals industry which returned 48.1% over the past year.
Return vs Market: BLTE exceeded the US Market which returned 11.9% over the past year.
Price Volatility
| BLTE volatility | |
|---|---|
| BLTE Average Weekly Movement | 7.4% |
| Pharmaceuticals Industry Average Movement | 8.3% |
| Market Average Movement | 6.8% |
| 10% most volatile stocks in US Market | 15.1% |
| 10% least volatile stocks in US Market | 2.9% |
Stable Share Price: BLTE has not had significant price volatility in the past 3 months compared to the US market.
Volatility Over Time: BLTE's weekly volatility (7%) has been stable over the past year.
About the Company
| Founded | Employees | CEO | Website |
|---|---|---|---|
| 2016 | 41 | Tom Lin | www.belitebio.com |
Belite Bio, Inc, a clinical stage biopharmaceutical drug development company, engages in the research and development of novel therapeutics with unmet medical needs in the United States. Its lead product candidate is Tinlarebant (LBS-008), an orally administered, which is in phase 3 clinical trial as an early intervention for maintaining the health and integrity of retinal tissues in stargardt disease type 1 and geographic atrophy patients. The company also develops LBS-009, an retinol binding protein 4 oral therapy, which is in preclinical development targeting liver disease, including non-alcoholic fatty liver disease, nonalcoholic steatohepatitis, and type 2 diabetes, as well as gout.
Belite Bio, Inc Fundamentals Summary
| BLTE fundamental statistics | |
|---|---|
| Market cap | US$6.88b |
| Earnings (TTM) | -US$102.36m |
| Revenue (TTM) | n/a |
0.0x
P/S Ratio-68.2x
P/E RatioIs BLTE overvalued?
See Fair Value and valuation analysisEarnings & Revenue
| BLTE income statement (TTM) | |
|---|---|
| Revenue | US$0 |
| Cost of Revenue | US$0 |
| Gross Profit | US$0 |
| Other Expenses | US$102.36m |
| Earnings | -US$102.36m |
Last Reported Earnings
Jun 30, 2026
Next Earnings Date
n/a
| Earnings per share (EPS) | -2.54 |
| Gross Margin | 0.00% |
| Net Profit Margin | 0.00% |
| Debt/Equity Ratio | 0% |
How did BLTE perform over the long term?
See historical performance and comparisonCompany Analysis and Financial Data Status
| Data | Last Updated (UTC time) |
|---|---|
| Company Analysis | 2026/09/21 22:09 |
| End of Day Share Price | 2026/09/21 00:00 |
| Earnings | 2026/06/30 |
| Annual Earnings | 2025/12/31 |
Data Sources
The data used in our company analysis is from S&P Global Market Intelligence LLC. The following data is used in our analysis model to generate this report. Data is normalised which can introduce a delay from the source being available.
| Package | Data | Timeframe | Example US Source * |
|---|---|---|---|
| Company Financials | 10 years |
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| Analyst Consensus Estimates | +3 years |
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| Market Prices | 30 years |
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| Ownership | 10 years |
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| Management | 10 years |
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| Key Developments | 10 years |
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* Example for US securities, for non-US equivalent regulatory forms and sources are used.
Unless specified all financial data is based on a yearly period but updated quarterly. This is known as Trailing Twelve Month (TTM) or Last Twelve Month (LTM) Data. Learn more.
Analysis Model and Snowflake
Details of the analysis model used to generate this report is available on our Github page, we also have guides on how to use our reports and tutorials on Youtube.
Learn about the who designed and built the Simply Wall St analysis model.
Industry and Sector Metrics
Our industry and section metrics are calculated every 6 hours by Simply Wall St, details of our process are available on Github.
Analyst Sources
Belite Bio, Inc is covered by 12 analysts. 9 of those analysts submitted the estimates of revenue or earnings used as inputs to our report. Analysts submissions are updated throughout the day.
| Analyst | Institution |
|---|---|
| Tazeen Ahmad | BofA Global Research |
| Whitney Ijem | Canaccord Genuity |
| Steven Seedhouse | Cantor Fitzgerald & Co. |