Last updated
Revenue
R&D Expenses
Operating CF
Total Assets
Total Liabilities
Equity
Shares Out.
D/E Ratio
Dilution Watch
Financials
52W LOW $75.9552W HIGH $200.00
Volume
184.76 K
Value Traded
20.08 M
Short % Float
2.66%
-3.84%Week
-17.59%1 Month
+3.6%3 Month
-6.78%6 Month
+998.4%5 Year
+998.4%All Time
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Market Cap
6.43 B
EPS (TTM)
-2.53
P/E Ratio
-
Ent. Value
5.23 B
Total Shares
40.27 M
Float Shares
39.55 M
Insiders
1.80%
Institutions
22.50%
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
PoA blends historical approval base rates, trial design score and FDA review track record.
BLTE Catalyst Timeline
Dated clinical, regulatory and corporate events for Belite Bio, Inc
Catalyst Timeline
Dated clinical, regulatory & corporate events for Belite Bio, Inc
270Total events
9Upcoming
53Tier-1 (high impact)
2022 to 2027Coverage
Upcoming catalysts 2
Event history 50
▲Topline ReadoutTinlarebantFiledClinical Data
Topline results from Phase 3 DRAGON study of tinlarebant in adolescent STGD1
Adolescent Stargardt Diseasesource ↗
●Oral PresentationPresentation
Belite Bio Company Overview oral presentation at Euretina Innovation Spotlight
inherited and rare retinal diseasessource ↗
●Oral PresentationTinlarebantFiledPresentation
Belite Bio Company Overview oral presentation at Euretina Innovation Spotlight
Stargardt disease type 1 (STGD1)source ↗
●NDA SubmissionTinlarebantFiledRegulatory Filing
NDA submitted to Japan MHLW for tinlarebant in STGD1
Stargardt disease type 1 (STGD1)source ↗
▲FDA Filing AcceptedTinlarebantFiledRegulatory Filing
FDA accepted NDA with Priority Review
Stargardt disease type 1source ↗
▲FDA Filing AcceptedTinlarebantFiledRegulatory Filing
FDA accepted NDA with Priority Review for tinlarebant
Stargardt disease type 1 (STGD1)source ↗
▲Oral PresentationTinlarebantFiledPresentation
Oral presentation of additional positive secondary endpoint data at ASRS 2026 Annual Meeting
Stargardt disease type 1 (STGD1)source ↗
▲Enrollment CompleteTinlarebantFiledTrial
Completed enrollment in DRAGON II trial with 73 subjects
Stargardt disease type 1 (STGD1)source ↗
▲FDA Filing AcceptedTinlarebantFiledRegulatory Filing
FDA acceptance of NDA for tinlarebant
Stargardt Disease Type 1source ↗
▲Priority ReviewTinlarebantFiledRegulatory Filing
FDA grants Priority Review for tinlarebant NDA
Stargardt Disease Type 1source ↗
▲FDA Filing AcceptedTinlarebantFiledRegulatory Filing
FDA accepted Belite Bio's NDA for tinlarebant for STGD1 with priority review
STGD1source ↗
▲Priority ReviewTinlarebantFiledRegulatory Filing
FDA granted Priority Review for tinlarebant NDA
Stargardt disease type 1 (STGD1)source ↗
▲FDA Filing AcceptedTinlarebantFiledRegulatory Filing
FDA accepted Belite Bio's NDA for tinlarebant for STGD1 with priority review
STGD1source ↗
▲Priority ReviewTinlarebantFiledRegulatory Filing
FDA granted priority review for tinlarebant NDA for STGD1
STGD1source ↗
●NDA SubmissionTinlarebantFiledRegulatory Filing
NDA submission to FDA for tinlarebant completed
Stargardt disease type 1source ↗
▲Oral PresentationTinlarebantFiledPresentation
Oral presentation at ASRS 2026 Annual Meeting featuring additional positive secondary endpoint data
Stargardt disease type 1source ↗
▲Primary Endpoint MetTinlarebantFiledClinical Data
Phase 3 DRAGON trial met primary efficacy endpoint: 35.7% reduction in retinal lesion growth rate
Stargardt disease type 1source ↗
◆Oral PresentationPresentation
Belite Bio to participate in Piper Sandler Virtual Ophthalmology Investor Symposium fireside chat
◆Oral PresentationTinlarebantFiledPresentation
Topline Results from the Phase 3 DRAGON Study of Tinlarebant for Adolescent Stargardt’s Disease at ISCEV 2026
Stargardt Diseasesource ↗
●Milestone PaymentTinlarebantFiledCorporate
Royalty payment for additional milestone achieved under license agreement
▲Rolling Submission CompletedTinlarebantFiledRegulatory Filing
Completed rolling submission of NDA to FDA for tinlarebant
Stargardt disease type 1source ↗
◆Oral PresentationPresentation
Fireside chat at Goldman Sachs 47th Annual Global Healthcare Conference
▲Primary Endpoint MetTinlarebantFiledClinical Data
Phase 3 DRAGON trial in STGD1 met primary endpoint
Stargardt disease type 1 (STGD1)source ↗
◆Oral PresentationTinlarebantFiledPresentation
Oral presentation of topline results from Phase 3 DRAGON trial at Retina China 2026
Stargardt disease type 1source ↗
▲Orphan Drug DesignationTinlarebantFiledDesignation
Granted Orphan Drug Status by Swissmedic for STGD1
Stargardt disease type 1 (STGD1)source ↗
▲Enrollment CompleteTinlarebantFiledTrial
Enrollment completed for PHOENIX trial with 530 subjects
Geographic Atrophy (GA)source ↗
◆Oral PresentationPresentation
H.C. Wainwright 4th Annual BioConnect Nasdaq Investor Conference fireside chat
▲Orphan Drug DesignationTinlarebantFiledDesignation
Swissmedic grants orphan drug status for tinlarebant in Stargardt disease
Stargardt diseasesource ↗
◆Oral PresentationTinlarebantFiledPresentation
Oral presentation of topline results from Phase 3 DRAGON trial at Retinal Therapeutics Innovation Summit
Stargardt disease type 1source ↗
◆Oral PresentationPresentation
Belite Bio to present at Deutsche Bank ADR Virtual Investor Conference
▲Enrollment CompleteTinlarebantFiledTrial
Completed enrollment in Phase 2/3 DRAGON II trial of tinlarebant in STGD1
Stargardt disease type 1 (STGD1)source ↗
▲Rolling Submission InitiatedTinlarebantFiledRegulatory Filing
Initiated rolling NDA submission to FDA for tinlarebant
Stargardt disease type 1 (STGD1)source ↗
●Rolling Submission InitiatedTinlarebantFiledRegulatory Filing
Initiated rolling NDA submission to FDA for tinlarebant in STGD1
Stargardt disease type 1 (STGD1)source ↗
◆Timing GuidanceTinlarebantFiledPresentation
Expects to complete NDA rolling submission in Q2 2026
Stargardt disease type 1 (STGD1)source ↗
●Rolling Submission CompletedTinlarebantFiledRegulatory Filing
Expect to complete rolling NDA submission in Q2 2026
Stargardt diseasesource ↗
◆Quarterly UpdateCorporate
Webcast to discuss Q4 and full year 2025 financial results and business update
▲Enrollment CompleteTinlarebantFiledTrial
Enrollment completed for DRAGON II trial with 73 subjects
Stargardt disease type 1 (STGD1)source ↗
◆Poster PresentationTinlarebantFiledPresentation
Sponsored lunch symposium on tinlarebant Phase 3 DRAGON results at APAO 2026
Stargardt disease type 1 (STGD1)source ↗
◆Oral PresentationTinlarebantFiledPresentation
Oral presentation of topline results from Phase 3 DRAGON study of tinlarebant in adolescent STGD1 at APAO 2026
Stargardt disease type 1 (STGD1)source ↗
◆Poster PresentationTinlarebantFiledPresentation
Exhibition booth at APAO 2026
Stargardt disease type 1 (STGD1)source ↗
▲Enrollment CompleteTinlarebantFiledTrial
Completed enrollment of 60 subjects in DRAGON II trial
Stargardt disease type 1 (STGD1)source ↗
●Timing GuidanceTinlarebantFiledPresentation
NDA submission for Tinlarebant planned in first half of 2026
Stargardt disease type 1 (STGD1)source ↗
Past FDA Catalysts and PDUFA Decisions
How BLTE actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-08-30 | Tinlarebant (LBS-008) | Phase 3 data presentation | Phase 3 |
Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision
Drug Pipeline Intelligence
C40 / 100
Pipeline Score
$296M
Pipeline Value
Richly Valued
Valuation Signal
3
Drugs Scored
0.0x
rNPV / MCap
Top 37%
Small Cap(rank 243 of 655)
Percentile Rank
Belite Bio, Inc carries a moderate pipeline score (40/100), with $483M risk-adjusted pipeline value, led by Tinlarebant in Healthy Volunteer (Phase 1).
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Tinlarebant Small moleculeCompletedNCT05244304 | Stargardt Disease 1 | Phase 3 | COMPLETED | 104 | Sep 11, 2025 |
Clinical Trial Results
Readouts, endpoints and source filings for every BLTE program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| tinlarebant BreakthroughPriorityFast Track+2 | Stargardt disease type 1 | Phase 3 | 2026-05-15 | In the Phase 3 DRAGON trial, tinlarebant achieved a clinically meaningful 35.7% reduction in the growth rate of atrophic retinal lesions compared to placebo, demonstrating its potential efficacy in treating Stargardt disease type 1.Read More | Belite Bio Announces Oral Presentation at the 27th Fundus Disease Forum and International Retinal Symposium (Retina China 2026)Read More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Lin Yu-HsinDirector, Officer (Chief Executive Officer) | Sell | -2,400 93,734 held | $194.33 | 09/08/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in BLTE
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| Paradigm Biocapital Advisors LP | 3.6 % | 189.84 M | 1.23 M | 10.59% ( 118.09 K) |
BLTE Institutional Ownership Trends
Options Data
Option Volume
Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
Vol 30-day avg
Today vs avg
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
CallsPutsLog scale
Competitive positioning
How BLTE ranks across every disease it competes in
Competitive Position is a premium feature
See how BLTE ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
Start free trialBLTE News
BLTEBelite Bio Announces Oral Presentations at Two Upcoming Medical Conferences
Belite Bio, a clinical-stage drug development company, announced that it will present data at two upcoming medical conferences in Vienna, Austria. The presentations will focus on the company's lead candidate, Tinlarebant, which targets Stargardt disease. The drug has received various designations from the FDA, highlighting its potential in treating retinal diseases.
Read more →BLTEBelite Bio Announces Submission of New Drug Application to the Ministry of Health, Labour, and Welfare in Japan under the Sakigake Designation System for Tinlarebant for the Treatment of Stargardt Disease Type 1
Belite Bio announced the submission of a New Drug Application for tinlarebant to treat Stargardt Disease Type 1 in Japan. This submission follows a similar application in the U.S. and aims to provide the first-ever treatment for this condition. Tinlarebant has received Sakigake designation, allowing for expedited review due to the significant unmet medical need.
Read more →BLTEBelite Bio to Participate in Four Upcoming Investor Conferences
Belite Bio, a clinical-stage drug development company, will participate in four investor conferences in September 2026. These events include the Wells Fargo Healthcare Conference, Cantor Global Healthcare Conference, Morgan Stanley Global Healthcare Conference, and H.C. Wainwright Investment Conference. The company aims to showcase its advancements in therapies for degenerative retinal diseases.
Read more →BLTEBelite Bio to Host Virtual Commercial Day on September 2, 2026
Belite Bio will host a Virtual Commercial Day on September 2, 2026, focusing on Stargardt disease type 1 (STGD1) and the potential of their drug tinlarebant. The event will feature experts in ophthalmology and discuss the unmet needs in STGD1 treatment. The FDA has accepted the New Drug Application for tinlarebant, with a Priority Review status and a Prescription Drug User Fee Act date set for February 12, 2027.
Read more →BLTE▼ -7.1%on this news
Belite Bio Reports Unaudited Second Quarter 2026 Financial Results and Provides a Corporate Update
Belite Bio reported its second quarter 2026 financial results, highlighting the FDA's acceptance of the New Drug Application for tinlarebant for Stargardt disease type 1 with a Priority Review status. The company presented encouraging data from the Phase 3 DRAGON trial at the ASRS Annual Meeting. Despite a net loss of $28.4 million, Belite is preparing for the drug's potential launch and expansion of its commercial operations.
Read more →BLTEBelite Bio Announces U.S. Food and Drug Administration Acceptance and Priority Review of New Drug Application for Tinlarebant for the Treatment of Stargardt Disease Type 1
Belite Bio has announced that the FDA has accepted its New Drug Application for tinlarebant, which is under priority review. If approved, tinlarebant will be the first-ever treatment for Stargardt Disease Type 1. The Prescription Drug User Fee Act target action date is set for February 12, 2027.
Read more →BLTEBelite Bio to Host Webcast on August 13, 2026, to Discuss Second Quarter 2026 Financial Results
Belite Bio, a clinical-stage drug development company, will host a webcast on August 13, 2026, to discuss its second-quarter financial results and provide a business update. The company focuses on therapeutics for degenerative retinal diseases, with its lead candidate, tinlarebant, currently in multiple trials. The webcast aims to inform stakeholders about the company's progress and financial health.
Read more →BLTEBelite Bio Announces Oral Presentation at the ASRS Annual Meeting Featuring Additional Positive Secondary Endpoint Data from the Phase 3 Trial of Tinlarebant in Stargardt Disease Type 1
Belite Bio announced positive secondary endpoint data from its Phase 3 DRAGON trial of tinlarebant for Stargardt disease type 1 at the ASRS Annual Meeting. The treatment demonstrated a significant reduction in retinal lesion growth and stable qAF values compared to placebo. The company has completed its New Drug Application to the FDA for tinlarebant.
Read more →BLTEBelite Bio to Participate in the H.C. Wainwright 6th Annual Ophthalmology Virtual Conference
Belite Bio, Inc. will participate in the H.C. Wainwright 6th Annual Ophthalmology Virtual Conference on July 22, 2026. The company focuses on developing therapies for degenerative retinal diseases, including Stargardt disease and geographic atrophy. Their lead candidate, tinlarebant, has met primary endpoints in a Phase 3 trial and is undergoing further evaluation.
Read more →BLTE▲ +5%on this news
Belite Bio to Participate in the Piper Sandler Virtual Ophthalmology Investor Symposium
Belite Bio, a clinical-stage drug development company, will participate in the Piper Sandler Virtual Ophthalmology Investor Symposium on July 9, 2026. The company focuses on developing therapeutics for degenerative retinal diseases, including Stargardt disease and geographic atrophy. Their lead candidate, tinlarebant, has completed a Phase 3 trial and is currently undergoing further evaluations.
Read more →BLTEBelite Bio Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt Disease Type 1
Belite Bio has completed the rolling submission of a New Drug Application for tinlarebant, an oral therapy aimed at treating Stargardt disease type 1. This submission, initiated under Breakthrough Therapy Designation, addresses a significant unmet medical need as there are currently no approved treatments for this rare retinal disease. The application will undergo a 60-day review by the FDA.
Read more →BLTE▼ -8.2%on this news
Belite Bio to Participate in the Goldman Sachs 47th Annual Global Healthcare Conference
Belite Bio, a clinical-stage drug development company, will participate in the Goldman Sachs 47th Annual Global Healthcare Conference on June 8, 2026. The company focuses on developing therapeutics for degenerative retinal diseases and has made progress with its lead candidate, tinlarebant, which has met primary endpoints in clinical trials. The event will be accessible via webcast.
Read more →BLTEBelite Bio Reports Unaudited First Quarter 2026 Financial Results and Provides a Corporate Update
Belite Bio reported its unaudited financial results for Q1 2026, highlighting a rolling NDA submission for tinlarebant aimed at treating Stargardt disease type 1 (STGD1). The company has completed hiring for its commercial leadership team and has a strong cash position of $798.6 million. However, it also reported a net loss of $26.9 million, reflecting increased R&D expenses associated with clinical trials.
Read more →BLTEBelite Bio Receives Orphan Drug Status for Tinlarebant in Stargardt Disease in Switzerland
Belite Bio has received orphan drug status for its lead candidate, tinlarebant, for the treatment of Stargardt disease from Swissmedic. This designation follows the successful Phase 3 DRAGON trial, where tinlarebant achieved a 35.7% reduction in retinal lesion growth. The company is also progressing with a rolling NDA submission to the FDA, expected to complete by Q2 2026.
Read more →BLTEBelite Bio Announces Oral Presentation at the 27th Fundus Disease Forum and International Retinal Symposium (Retina China 2026)
Belite Bio will present at the 27th Fundus Disease Forum in Nanjing, China, discussing the positive topline results from the Phase 3 DRAGON trial of tinlarebant for Stargardt disease type 1. The trial demonstrated a 35.7% reduction in the growth rate of retinal lesions compared to placebo. Tinlarebant is a novel oral therapy aimed at reducing toxic accumulations in the retina.
Read more →BLTEBelite Bio to Host Webcast on May 20, 2026, to Discuss First Quarter 2026 Financial Results
Belite Bio, a clinical-stage biopharmaceutical company, will host a webcast on May 20, 2026, to discuss its first quarter financial results and provide a business update. The company focuses on developing therapies for degenerative retinal diseases, including Stargardt disease and geographic atrophy. Their lead candidate, tinlarebant, is currently in various stages of clinical trials.
Read more →BLTEBelite Bio Announces Oral Presentation at the Retinal Therapeutics Innovation Summit
Belite Bio announced an upcoming oral presentation at the Retinal Therapeutics Innovation Summit on May 1, 2026. The presentation will highlight positive topline results from the Phase 3 DRAGON trial of tinlarebant for treating Stargardt disease type 1. The trial showed a significant reduction in retinal lesion growth and a favorable safety profile.
Read more →About Belite Bio, Inc
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