| Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA 2026 | Example Drug Treatment for example condition requiring FDA review | Phase 3 | -% | FDA review of the new drug application for the treatment of example condition. Read More | Small Molecule | Oncology | |
PDUFA 2026 | Example Drug Treatment for example condition requiring FDA review | Phase 3 | -% | FDA review of the new drug application for the treatment of example condition. Read More | Small Molecule | Oncology | |
PDUFA 2026 | Example Drug Treatment for example condition requiring FDA review | Phase 3 | -% | FDA review of the new drug application for the treatment of example condition. Read More | Small Molecule | Oncology |
Recent Updates
Recently added Catalysts
Belite Bio, Inc$146.63
+4.32 (+3.04%)
D 38Pipeline Score Richly Valued Pharma · Clinical
Market Cap
5.50 B
EPS
-2.53
P/E Ratio
-
Value Trade
22.48 M
-8.33 %
Week
-18.71 %
1 Month
-23.92 %
3 Month
24.73 %
6 Month
998.4 %
5 Year
998.4 %
All Time
Cash Data
Cash Position
12.35 K
Monthly Burn
12.35 K
Runway
12,345 mo
Overview
Volume
109.39 K
52 Week Range
56.10 - 200
% held by Insiders
1.27 %
% held by Institutions
22.43 %
Enterprise Value
5.23 B
Total Shares
40.09 M
Short %
3.35 %
Float Shares
39.57 M
Company Description
locked
Upcoming Catalyst
Catalyst Timeline
Dated clinical, regulatory & corporate events for Belite Bio, Inc
232Total events
5Upcoming
40Tier-1 (high impact)
2022 – 2026Coverage
Upcoming catalysts 5
Event history 227
Jun 12, 2026
▲Rolling Submission CompletedTinlarebantRegulatory Filing
Completed rolling submission of NDA to FDA for tinlarebant
Stargardt disease type 1source ↗
Jun 8, 2026
◆Oral PresentationPresentation
Fireside chat at Goldman Sachs 47th Annual Global Healthcare Conference
Jun 2, 2026
▲Primary Endpoint MetTinlarebantClinical Data
Phase 3 DRAGON trial in STGD1 met primary endpoint
Stargardt disease type 1 (STGD1)source ↗
May 26, 2026
May 22, 2026
◆Oral PresentationTinlarebantPresentation
Oral presentation of topline results from Phase 3 DRAGON trial at Retina China 2026
Stargardt disease type 1source ↗
May 20, 2026
▲Orphan Drug DesignationTinlarebantDesignation
Granted Orphan Drug Status by Swissmedic for STGD1
Stargardt disease type 1 (STGD1)source ↗
May 20, 2026
▲Enrollment CompleteTinlarebantTrial
Enrollment completed for PHOENIX trial with 530 subjects
Geographic Atrophy (GA)source ↗
May 19, 2026
◆Oral PresentationPresentation
H.C. Wainwright 4th Annual BioConnect Nasdaq Investor Conference fireside chat
May 18, 2026
▲Orphan Drug DesignationTinlarebantDesignation
Swissmedic grants orphan drug status for tinlarebant in Stargardt disease
Stargardt diseasesource ↗
May 13, 2026
May 1, 2026
◆Oral PresentationTinlarebantPresentation
Oral presentation of topline results from Phase 3 DRAGON trial at Retinal Therapeutics Innovation Summit
Stargardt disease type 1source ↗
Drug Pipeline Intelligence
D38
Pipeline Score $442M
Pipeline ValueRichly Valued
Valuation Signal3
Drugs Scored0.1x
rNPV / MCap Top 54%
Small Cap (rank 418 of 906)
Percentile RankBelite Bio, Inc faces pipeline headwinds (38/100), with $729M risk-adjusted pipeline value, led by Tinlarebant in Healthy Volunteer (Phase 1).
Showing 1 of 1 assets
| Drug | Indication | Phase | NCT ID | PTRS | rNPV | Status | Enrollment | Velocity | Design | Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Tinlarebant Small molecule | Stargardt Disease 1 | Phase 3 | NCT05244304 | 90% | $586M | COMPLETED | 104 | - | - | Sep 12, 2025 | - | Oct 31, 2025 |
Clinical Trial Results
| Drug Name | Indications | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
tinlarebant | 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 | |
tinlarebant | 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 | |
tinlarebant | 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
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLDINSIDERS
BOUGHT
SOLDINSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Hedge Funds
Shares Held
HEDGE FUNDS
SOLDHEDGE FUNDS
BOUGHT
SOLDHEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Hedge Funds invested in BLTE
| HedgeFund Name ( 3 ) | % of Portfolio | Current MV - | Shares Owned - | Activity Avg Price $0 |
|---|---|---|---|---|
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K |
BLTE Institutional Ownership Trends
Current Insider %
5.20%
—+0.00%
Current Institutional %
62.40%
—+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
| Expiration | Volume | Open Interest | Implied Volatility Calls | Implied Volatility Puts | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calls | Puts | Put-Call Ratio | Calls | Puts | Put-Call Ratio | IV | OiWaIv | VWaIv | IV | OiWaIv | VWaIv | |
Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last Price | Volume | Open Interest | Last Price | Volume | Open Interest | |
| No data available | ||||||
Open interest
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
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 →BLTEBelite 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 →BLTEBelite Bio to Participate in Four Upcoming Investor Conferences
Belite Bio, a clinical-stage drug development company, has announced its participation in four upcoming investor conferences. These events include presentations at the Deutsche Bank American Depositary Receipt Virtual Investor Conference, BofA Securities Health Care Conference, H.C. Wainwright BioConnect Nasdaq Investor Conference, and Stifel Virtual Ophthalmology Forum. The company aims to showcase its advancements in therapeutics for degenerative retinal diseases.
Read more →BLTEBelite Bio to Present at the Deutsche Bank American Depositary Receipt Virtual Investor Conference on April 28th
Belite Bio, Inc. (NASDAQ: BLTE) will present at the Deutsche Bank American Depositary Receipt Virtual Investor Conference on April 28, 2026. Dr. Hendrick Scholl, the Chief Medical Officer, will lead the presentation, which allows for real-time interaction with investors. This comes shortly after the company initiated a New Drug Application for its product, tinlarebant, targeting Stargardt disease, following promising results from a Phase 3 trial.
Read more →BLTEBelite Bio Initiates Rolling Submission of New Drug Application to the U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt Disease
Belite Bio has initiated a rolling submission of a New Drug Application (NDA) for tinlarebant, an oral therapy aimed at treating Stargardt disease type 1. The FDA has granted Breakthrough Therapy Designation for this investigational drug, which is expected to complete its NDA submission by the second quarter of 2026. This marks a significant step for patients suffering from this rare retinal disorder.
Read more →BLTEBelite Bio Announces Availability of Annual Report on Form 20-F Through Company Website
Belite Bio, Inc. has announced the availability of its annual report on Form 20-F for the year ended December 31, 2025. The report includes audited financial statements and is accessible on the company's website. Shareholders can request a hard copy free of charge. The company continues to focus on developing treatments for degenerative retinal diseases.
Read more →BLTEBelite Bio to Participate in the Leerink Global Healthcare Conference
Belite Bio, Inc. will participate in the Leerink Global Healthcare Conference on March 9, 2026. The company focuses on developing therapies for degenerative retinal diseases, including Stargardt disease and geographic atrophy. Their lead candidate, tinlarebant, aims to reduce harmful toxins in the eye and has completed a Phase 3 trial.
Read more →BLTEBelite Bio Reports Preliminary, Unaudited Fourth Quarter and Full Year 2025 Financial Results and Provides a Corporate Update
Belite Bio reported positive topline results from its Phase 3 DRAGON trial for tinlarebant, a potential treatment for Stargardt disease. The company is set to submit a New Drug Application to the FDA in Q2 2026. They also completed a significant public offering, raising $402 million. However, the company reported increased net losses for both the fourth quarter and full year of 2025.
Read more →BLTEBelite Bio to Host Webcast on March 2, 2026, to Discuss Preliminary, Unaudited Fourth Quarter and Full Year 2025 Financial Results
Belite Bio, Inc. will host a webcast on March 2, 2026, to discuss its preliminary, unaudited financial results for Q4 and the full year 2025. The company is dedicated to developing therapeutics for degenerative retinal diseases and has ongoing clinical trials for its lead candidate, tinlarebant. The webcast will provide insights into the company's financial performance and business updates.
Read more →BLTEBelite Bio Announces Participation at the 41st Asia-Pacific Academy of Ophthalmology Congress (APAO)
Belite Bio, Inc. will participate in the 41st Asia-Pacific Academy of Ophthalmology Congress in Hong Kong from February 5-7, 2026. The company will present topline results from its Phase 3 DRAGON study of tinlarebant for Stargardt disease type 1, alongside individual patient case reports. The event will feature an oral presentation, a sponsored lunch symposium, and an exhibition booth.
Read more →BLTEBelite Bio Completes Enrollment in the DRAGON II Clinical Trial of Tinlarebant for Stargardt Disease (STGD1)
Belite Bio has completed enrollment of 60 subjects in the Phase 2/3 DRAGON II clinical trial for tinlarebant, aimed at treating Stargardt disease type 1. The trial, which includes participants from Japan, the U.S., and the U.K., is designed to assess the drug's efficacy and safety. The company plans to submit a New Drug Application to the FDA in early 2026.
Read more →BLTENew Hope for People Living with a Disease Once Deemed Untreatable: Belite Bio Announces Positive Topline Results from the Pivotal Global, Phase 3 DRAGON Trial of Tinlarebant in Adolescents with Stargardt Disease
Belite Bio announced positive topline results from the Phase 3 DRAGON trial of Tinlarebant, showing a 36% reduction in retinal lesion growth in adolescents with Stargardt disease type 1. This marks a significant milestone as it is the first successful pivotal trial for this previously untreatable condition. The results support the potential for regulatory approval and a new treatment option for patients.
Read more →BLTEBelite Bio Announces Pricing of $350.0 Million Underwritten Public Offering of American Depositary Shares
Belite Bio has announced the pricing of its underwritten public offering of 2,272,727 American Depositary Shares at a price of $154.00 per share, aiming to raise approximately $350 million. The funds raised will be utilized for commercialization efforts, development of drug pipelines, and general corporate expenses. This offering is set to close on or about December 3, 2025, pending customary conditions. The company is actively progressing with its lead candidate, Tinlarebant, for treating degenerative retinal diseases.
Read more →BLTEBELITE BIO, INC CONDENSED CONSOLIDATED BALANCE SHEETS (Amounts in thousands of US Dollars, except share and per share amounts) (Unaudited)
Belite Bio, Inc. reported its condensed consolidated balance sheets and statements of operations for the nine months ending September 30, 2025. The company experienced a substantial increase in net loss, rising to $52,287 compared to $26,044 in the previous year. Operating expenses also more than doubled, primarily due to increased research and administrative costs. Additionally, the accumulated deficit saw a significant increase from $107,647 in 2024 to $159,934 in 2025.
Read more →BLTEBelite Bio Announces Proposed Underwritten Public Offering of American Depositary Shares
Belite Bio announced a proposed underwritten public offering of American Depositary Shares (ADSs) to raise funds for various corporate purposes. The company intends to use the net proceeds to support commercialization efforts, expand its pipeline, and for general working capital. The offering, which is subject to market conditions, allows underwriters a 30-day option to purchase additional ADSs. Belite's lead candidate, Tinlarebant, has completed a Phase 3 trial and is currently involved in ongoing clinical evaluations.
Read more →BLTEBelite Bio Reports Third Quarter 2025 Financial Results and Provides a Corporate Update
Belite Bio reported its financial results for Q3 2025, highlighting progress in developing Tinlarebant for Stargardt disease. The company received positive feedback from regulatory bodies in China and the UK regarding its New Drug Application. Despite a significant net loss, Belite maintains a strong financial position with over $275 million in assets.
Read more →BLTEBelite Bio to Host Webcast on November 10, 2025, to Discuss Third Quarter 2025 Financial Results
Belite Bio, Inc. will host a webcast on November 10, 2025, to discuss its third quarter financial results and provide a business update. The event will take place at 4:30 p.m. Eastern Time. The company is focused on developing therapeutics for degenerative retinal diseases and is currently evaluating its lead candidate in multiple clinical trials.
Read more →BLTEBelite Bio Announces UK’s Medicines and Healthcare Products Regulatory Agency Agrees to Conditional Marketing Authorization Application Based on Interim Analysis Results for the Treatment of Stargardt Disease with Tinlarebant
Belite Bio announced that the UK's MHRA has accepted a Conditional Marketing Authorization application for Tinlarebant, based on interim results from the Phase 3 DRAGON trial for Stargardt disease. The company aims to provide the first approved therapy for this condition, which currently has no approved treatments. Final data from the trial is expected in Q4 2025.
Read more →BLTEBelite Bio to Participate in the Deutsche Bank ADR Virtual Investor Conference
Belite Bio Inc. will present at the Deutsche Bank ADR Virtual Investor Conference on November 4, 2025. The company is focused on developing therapeutics for degenerative retinal diseases. Their lead candidate, Tinlarebant, is currently undergoing evaluation in multiple clinical studies. A webcast of the presentation will be available for 90 days post-event.
Read more →BLTEBelite Bio to Present at the dbVIC - Deutsche Bank ADR Virtual Investor Conference November 4th
Belite Bio Inc. (NASDAQ: BLTE) announced that CFO Hao-Yuan Chuang will present at the dbVIC - Deutsche Bank ADR Virtual Investor Conference on November 4, 2025. This event is designed to facilitate introductions between global ADR companies and investors, allowing for live interaction and questions. Investors unable to attend will have access to an archived webcast, ensuring broader accessibility to the presentation.
Read more →BLTEBelite Bio to Participate in the 2025 Maxim Growth Summit
Belite Bio Inc. announced its participation in the Maxim Growth Summit on October 22, 2025. The company focuses on developing therapies for degenerative retinal diseases and is currently advancing its lead candidate, Tinlarebant, through multiple clinical trials. This engagement highlights Belite's commitment to addressing unmet medical needs in the field.
Read more →BLTEBelite Bio Announces China NMPA Agrees to New Drug Application with Priority Review based on Interim Analysis Results for the Treatment of Stargardt Disease with Tinlarebant
Belite Bio announced that the NMPA in China has agreed to a priority review of their New Drug Application for Tinlarebant, based on interim analysis from the Phase 3 DRAGON trial for Stargardt disease. This milestone highlights the urgent need for effective treatments in a condition with no approved options. The company plans to submit final data by Q4 2025.
Read more →BLTEBelite Bio Announces Completion of DRAGON, a 2-Year, Phase 3 Trial of Oral Tinlarebant in the Treatment of Stargardt Disease
Belite Bio has successfully completed the Phase 3 DRAGON trial for Tinlarebant, aimed at treating Stargardt disease. The trial involved 104 adolescent subjects across 11 countries, with 94 completing the study. Results are expected in Q4 2025, and the company plans to file for New Drug Applications in the first half of 2026. Tinlarebant could be the first approved therapy for this condition.
Read more →BLTEBelite Bio Announces Up to $275 Million Upsized Private Placement Financing by Leading Healthcare Investors
Belite Bio has announced a private placement financing expected to yield up to $275 million, aimed at advancing its drug development for retinal diseases. The financing includes an initial $125 million with potential additional funds from warrant exercises. The company plans to utilize the proceeds for commercialization and working capital.
Read more →BLTEBelite Bio to Participate in Three Upcoming Investor Conferences
Belite Bio, a clinical-stage drug development company, will participate in three upcoming investor conferences. The management team aims to showcase their advancements in therapeutics for degenerative retinal diseases. Their lead candidate, Tinlarebant, is currently undergoing evaluation in multiple clinical studies, targeting conditions like Stargardt disease and Geographic Atrophy.
Read more →BLTEBelite Bio Reports Second Quarter 2025 Financial Results and Provides a Corporate Update
Belite Bio, Inc. (BLTE) announced its Q2 2025 financial results, highlighting significant milestones including the completion of enrollment in its Phase 3 PHOENIX trial for geographic atrophy and the granting of Breakthrough Therapy Designation for Tinlarebant for Stargardt disease by the FDA. The company raised approximately $15 million through a direct offering but also reported increased net losses and rising research and administrative expenses. A conference call is scheduled for August 11, 2025, to discuss the financial results and strategic objectives.
Read more →BLTEBelite Bio Reports Second Quarter 2025 Financial Results and Provides
Belite Bio, Inc. announced its financial results for the second quarter of 2025, highlighting its ongoing clinical development and financial stability. The company has successfully completed enrollment in the Phase 3 PHOENIX trial and received Breakthrough Therapy Designation for its lead candidate Tinlarebant, targeting Stargardt disease. However, Belite reported a net loss of $16.3 million for the quarter, a significant increase from the previous year, primarily driven by rising administrative costs. Despite this, the positive progress in clinical trials and substantial cash reserves suggest a focused path forward.
Read more →BLTEBelite Bio Announces Registered Direct Offering of $15 Million The offering was to a single large existing institutional shareholder
Belite Bio, Inc. has announced a registered direct offering of $15 million, intended for a single existing institutional shareholder. The offering will involve American Depositary Shares and warrants at a purchase price of $65 per ADS. Proceeds from this offering will be allocated for working capital and general corporate purposes. The closing is expected to occur around August 8, 2025, subject to customary conditions.
Read more →BLTEBelite Bio to Participate in the H.C. Wainwright Annual Ophthalmology Virtual Conference
Belite Bio, Inc. announced its planned participation in the H.C. Wainwright Annual Ophthalmology Virtual Conference. The company's executive management team will engage in a panel discussion and present corporate information on August 13, 2025. The conference will include a focus on pivotal-stage assets related to retinal disorders, showcasing Belite's commitment to developing therapeutics for these unmet medical needs. Webcast links for the presentations will be available on their investor relations website.
Read more →BLTEBelite Bio to Host Webcast on August 11, 2025, to Discuss Second Quarter 2025 Financial Results
Belite Bio, Inc., a clinical-stage drug development company, has announced a webcast to discuss its financial results and give a business update for the second quarter of 2025. The event is scheduled for August 11, 2025, at 4:30 p.m. Eastern Time. Participants can access the webcast through a provided link or the company's Investor Relations website. A replay will be available for 90 days following the event.
Read more →BLTEBelite Bio to Participate in the BTIG Virtual Biotechnology Conference
Belite Bio, Inc., a clinical-stage drug development company, announced participation in the upcoming BTIG Virtual Biotechnology Conference scheduled for July 29-30, 2025. The event aims to facilitate engagement between the company's executive management team and interested investors. The company's focus is on developing novel therapeutics for degenerative retinal diseases, an area with substantial unmet medical needs.
Read more →BLTEBelite Bio Announces Completion of Enrollment in the Pivotal Global Phase 3 PHOENIX Trial Evaluating Oral Tinlarebant in Geographic Atrophy - 500 subjects enrolled across the United States, the United Kingdom, France, Cz
Belite Bio has completed enrollment in the global Phase 3 PHOENIX trial for its oral drug Tinlarebant, aimed at treating geographic atrophy in patients with dry age-related macular degeneration. The trial will evaluate the drug's efficacy in slowing atrophic lesion growth over a 24-month period. With no currently approved oral treatments for this condition, the outcome of this study is crucial for addressing a significant gap in treatment options. Belite Bio plans to share interim results during the study's midpoint, illustrating their commitment to the development of this therapy.
Read more →BLTEBelite Bio Announces FDA Granting of Breakthrough Therapy Designation for Tinlarebant for the Treatment of Stargardt Disease - Designation is based on the pivotal Phase 3 DRAGON trial interim analysis results demonstrati
Belite Bio has received FDA Breakthrough Therapy Designation for Tinlarebant, aimed at treating Stargardt disease based on interim results from the Phase 3 DRAGON trial. This designation highlights the drug's significant potential to address the unmet needs of patients suffering from STGD1, a condition with no current approved therapies. The interim analysis indicates a favorable safety profile, with the majority of participants maintaining stable visual acuity. Belite Bio plans to advance the drug further, with the full trial results expected by the end of the year.
Read more →BLTEBelite Bio Reports First Quarter 2025 Financial Results and Provides Corporate Update Following a pre-specified interim analysis, an independent Data Safety Monitoring Board (DSMB) recommended the pivotal Phase 3 trial (
Belite Bio, Inc. has reported its financial results for the first quarter of 2025, noting a significant net loss of $14.3 million. The company highlighted a favorable interim analysis from the Data Safety Monitoring Board regarding its pivotal Phase 3 DRAGON trial for Tinlarebant. As of the end of March 2025, Belite reported a strong cash position of $157.4 million. The company continues to address the unmet medical needs associated with degenerative retinal diseases while facing increasing expenses in research and development.
Read more →BLTEBelite Bio, Inc to Present at the dbVIC - Deutsche Bank ADR Virtual Investor Conference May 15th
Belite Bio, Inc (NASDAQ: BLTE) announced that its Chief Science Officer, Dr. Nathan L. Mata, will present at the dbVIC - Deutsche Bank ADR Virtual Investor Conference on May 15, 2025. This online event is designed to connect global companies with ADR programs to potential investors. Belite Bio is currently advancing its drug development programs, including a pivotal Phase 3 trial for Tinlarebant targeting Stargardt disease, which is expected to be completed by Q4 2025. The company received a favorable recommendation for drug approval following an interim analysis of the trial.
Read more →BLTEBelite Bio to Host Webcast on May 14, 2025, to Discuss First Quarter 2025 Financial Results
Belite Bio, a clinical-stage biopharmaceutical company, will host a webcast on May 14, 2025, to discuss its financial results for the first quarter of 2025, ending March 31. This event reflects the company's commitment to keeping its investors informed about its financial performance and business developments. Participants can access the webcast via a specific link, which will remain available for 90 days post-event.
Read more →BLTEBelite Bio Announces Poster Presentations at the Association for Research in Vision and Ophthalmology 2025 Annual Meeting
Belite Bio, Inc. will present two posters at the ARVO Annual Meeting in May 2025, highlighting key findings from the DRAGON trials focused on Stargardt Disease. The presentations will emphasize baseline patient characteristics and pharmacokinetic properties of Tinlarebant, an investigational drug intended to treat patients with this condition. Tinlarebant aims to reduce the accumulation of harmful toxins associated with retinal diseases, and it has received several regulatory designations that underline its significance in addressing unmet medical needs in eye care.
Read more →BLTEBelite Bio Announces Results of 2025 General Meeting
Belite Bio, Inc. held its 2025 general meeting in San Diego on April 15, where shareholders approved several resolutions regarding board membership. The meeting resulted in the re-election of multiple existing directors, while also marking the removal of one director, Ms. Hung-Wei Chen. Additionally, Ms. Xiao-Hui Chen was elected as a new director. These changes reflect a shift in leadership and governance within the company as it continues to focus on therapies for degenerative retinal diseases.
Read more →BLTEBELITE BIO, INC NOTICE OF ANNUAL GENERAL MEETING OF SHAREHOLDERS TO BE HELD ON APRIL 15, 2025 Dear Shareholder, Notice is hereby given that Belite Bio, Inc, a Cayman Islands company (the "Company"), will hold its annual
Belite Bio, Inc. has announced its annual general meeting of shareholders scheduled for April 15, 2025, at its San Diego office. This meeting will provide an opportunity for shareholders to consider and vote on key resolutions. The notice specifies that only registered shareholders by the closing date of March 14, 2025, will be eligible to participate. Details regarding voting procedures and proxy submission are included.
Read more →BLTEBelite Bio Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update Following a pre-specified interim analysis, the Data Safety Monitoring Board (DSMB) recommended the DRAGON trial, a piv
Belite Bio, Inc. reported its financial results for the fourth quarter and full year ended December 31, 2024, showcasing important clinical progress. An independent Data Safety Monitoring Board (DSMB) recommended the continuation of the Phase 3 DRAGON trial, expressing confidence in the safety profile of the lead candidate, Tinlarebant. However, the company reported a net loss increase, highlighting rising operating expenses and a significant decrease in cash reserves. Despite these challenges, the company remains optimistic about upcoming milestones in its clinical development efforts.
Read more →BLTEBelite Bio to Host Webcast on March 17, 2025, to Discuss Fourth Quarter and Full Year 2024 Financial Results
Belite Bio, Inc. has announced a scheduled webcast for March 17, 2025, at 4:30 p.m. Eastern Time to discuss its financial results for the fourth quarter and full year ending December 31, 2024. The event will also include a business update, reflecting the company's ongoing commitment to its development in the biopharmaceutical sector. Investors can join through a provided link and a replay will be accessible for 90 days post-event.
Read more →BLTEBelite Bio to Participate in the Leerink Partners Global Healthcare Conference
Belite Bio, Inc. will participate in the Leerink Partners Global Healthcare Conference scheduled for March 10-12, 2025, in Miami, Florida. The company's executive team will host a fireside chat on March 10, 2025, at 3:00 PM ET. This event is an opportunity for Belite Bio to showcase its advancements in therapeutics for degenerative retinal diseases. A webcast of the chat will be available for 90 days post-event.
Read more →BLTEBelite Bio Announces Interim Analysis Results from the Pivotal Global Phase 3 DRAGON trial of Tinlarebant in Adolescent Stargardt Disease Subjects An independent Data Safety Monitoring Board (DSMB) for the Phase 3 DRAGON
Belite Bio has announced the results of an interim analysis from its global Phase 3 DRAGON trial of Tinlarebant in adolescent patients with Stargardt disease. The Data Safety Monitoring Board (DSMB) has recommended that the trial continue without any modifications, suggesting that the current sample size is adequate. The trial's safety profile remains consistent, and the majority of subjects exhibited stabilized visual acuity. Belite is on track to complete the trial by Q4 2025, building on promising results identified in the previous Phase 2 trial.
Read more →BLTEBelite Bio Announces Registered Direct Offering of $15 Million
Belite Bio has announced a registered direct offering to sell $15 million worth of American Depositary Shares (ADSs) and warrants. The offering, priced at $58.07 per ADS, reflects a successful partnership with a healthcare investor. Proceeds from this transaction are aimed at supporting working capital and other corporate purposes. The closing of the offering is anticipated to occur on or around February 7, 2025, subject to customary conditions. The company is focused on developing treatments for degenerative retinal diseases with significant unmet needs.
Read more →BLTEBelite Bio Reports Third Quarter 2024 Financial Results and Provides a Corporate Update Dosed first patient in Phase 2/3 DRAGON II trial of Tinlarebant for the treatment of Stargardt disease (STGD1) Pivotal global Phase
Belite Bio reported its third quarter 2024 financial results, highlighting continued progress in its clinical programs. The company announced the successful dosing of the first patient in the Phase 2/3 DRAGON II trial of Tinlarebant for Stargardt disease. Additionally, Belite appointed Dr. Scholl as its Chief Medical Officer, who is recognized in the field of retinal diseases. Despite some growth in R&D expenses, the company reported a net loss of $8.7 million compared to $10.9 million in the prior year.
Read more →BLTEBelite Bio to Host Webcast on November 12, 2024, to Discuss Third Quarter 2024 Financial Results
Belite Bio, Inc (NASDAQ: BLTE) has announced a webcast scheduled for November 12, 2024, at 4:30 p.m. Eastern Time. The event will focus on discussing the company's financial results for the third quarter ended September 30, 2024, as well as provide a business update. Interested parties can join the webinar through a specified link. A replay will be available for 90 days after the event.
Read more →BLTEBelite Bio Announces Exercise of Warrants for US$28.75 Million Gross Proceeds
Belite Bio, Inc. has announced the immediate exercise of certain outstanding warrants, expected to generate approximately US$28.75 million in gross proceeds. This exercise involves the purchase of up to 651,380 ordinary shares at an exercise price of US$44.14 per share. Additionally, new unregistered warrants will be issued, allowing investors to purchase shares at US$70.00 each, potentially yielding gross proceeds of about US$45.6 million if fully exercised. The company plans to use the net proceeds for general corporate purposes and expects the offering to close by November 4, 2024.
Read more →BLTEBelite Bio Announces Presentations at the American Academy of Ophthalmology 2024 Annual Meeting
Belite Bio, Inc. announced that it will present data from its Phase II adolescent Stargardt disease trial at the upcoming American Academy of Ophthalmology Annual Meeting in Chicago. The presentations will include a podium presentation on the novel oral therapy Tinlarebant (LBS-008) and an e-poster on an oral retinol binding protein 4 antagonist. Tinlarebant aims to address the accumulation of bisretinoids causing vision loss in Stargardt Disease type 1, and has received several designations indicating its potential significance in treating this unmet medical need.
Read more →BLTEBelite Bio to Participate in the Maxim Group 2024 Healthcare Virtual Summit
Belite Bio, Inc. (NASDAQ: BLTE) has announced its participation in the Maxim Group 2024 Healthcare Virtual Summit. Chief Medical Officer Hendrik P.N. Scholl will be part of a panel discussion on ocular drug development scheduled for October 15, 2024. This participation highlights Belite Bio's commitment to addressing significant unmet medical needs in degenerative retinal diseases. Attendees can access the live panel discussion through Maxim's M-Vest website.
Read more →BLTEBelite Bio Announces First Patient Dosed in Phase 2/3 DRAGON II Trial of Tinlarebant for the Treatment of Stargardt Disease
Belite Bio has announced the dosing of the first patient in the Phase 2/3 DRAGON II trial of its novel oral therapy, Tinlarebant, designed to treat Stargardt Disease (STGD1). This trial will focus on the efficacy, safety, and tolerability of Tinlarebant in around 60 adolescent subjects across the U.S., U.K., and Japan. The company recently completed a Phase 1b trial in Japan, where Tinlarebant was granted Orphan Drug and Sakigake designations, emphasizing its potential importance for treating this historically untreatable condition. Enrollment in the trial is actively progressing, with notable interest from patients and healthcare professionals alike.
Read more →BLTEBelite Bio Announces Appointment of Hendrik P. N. Scholl, MD, MA, as Chief Medical Officer Dr. Scholl is a globally recognized leader in the field of ophthalmology and the coordinating principal investigator of the large
Belite Bio announced the appointment of Dr. Hendrik P. N. Scholl as its new Chief Medical Officer. Dr. Scholl, a recognized expert in ophthalmology, brings extensive experience in treating retinal diseases, particularly Stargardt disease and age-related macular degeneration (AMD). His leadership is expected to bolster Belite's clinical programs and validate the potential of their lead drug candidate, Tinlarebant, aimed at addressing unmet medical needs in these conditions. This strategic move reflects Belite Bio's commitment to advancing innovative therapies in the field of ophthalmology.
Read more →BLTEBelite Bio Reports Second Quarter 2024 Financial Results and Provides a Corporate Update Tinlarebant , a novel oral therapy, is intended to slow disease progression in patients affected with Stargardt Disease (STGD1) and
Belite Bio reported its financial results for Q2 2024, noting significant advancements in its clinical programs, particularly for Tinlarebant, aimed at treating Stargardt Disease. The company achieved Sakigake designation in Japan and progressed towards key milestones in its clinical trials. Despite a net loss of $9.5 million in the quarter and increased R&D expenses, Belite raised $25 million to bolster its financial standing. The company is optimistic about the upcoming interim analysis from its pivotal Phase 3 trial set for Q4 2024.
Read more →BLTEBelite Bio Reports Second Quarter 2024 Financial Results and Provides a Corporate Update
Belite Bio has reported its financial results for Q2 2024, illustrating progress in its drug candidate Tinlarebant for Stargardt Disease and Geographic Atrophy. The company has initiated the DRAGON II trial and enrolled approximately 200 patients in the ongoing PHOENIX Phase 3 trial. Despite a net loss of $9.5 million in Q2, Belite secured $25 million in funding and received key designations in Japan. An interim analysis for its pivotal trials is anticipated in late 2024.
Read more →BLTEBelite Bio to Present at the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference
Belite Bio, Inc. (NASDAQ: BLTE) has announced that its Chief Scientific Officer, Dr. Nathan Mata, will present a corporate update at the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference. The event will take place on August 15, 2024, and will be broadcast at 7:00 am ET. A replay of the presentation will be accessible for 90 days on the company's investor relations website. This update highlights Belite's commitment to advancing therapies for degenerative retinal diseases.
Read more →BLTEBelite Bio to Host Webcast on August 12, 2024, to Discuss Second Quarter 2024 Financial Results
Belite Bio, Inc. has announced plans to host a webcast on August 12, 2024, at 4:30 p.m. ET to discuss its financial results for the second quarter ended June 30, 2024. The webcast aims to provide a business update and will be available for replay for approximately 90 days after the event. This initiative highlights Belite's commitment to keeping stakeholders informed about its progress in developing therapeutics for degenerative retinal diseases.
Read more →BLTEBelite Bio to Present at the JonesHealthcare Seaside Summit
Belite Bio, Inc. is set to participate in the JonesHealthcare Seaside Summit on July 15, 2024. Dr. Nathan Mata, the Chief Scientific Officer, will deliver a corporate update regarding the company's efforts in developing novel therapeutics for degenerative retinal diseases. The presentation will be accessible via webcast, with a replay available for 90 days. This engagement underscores Belite Bio's commitment to tackling significant medical needs in ophthalmology.
Read more →BLTEBelite Bio Receives Sakigake (Pioneer Drug) Designation of Tinlarebant for Stargardt Disease in Japan
Belite Bio has received Sakigake (Pioneer Drug) designation for its oral medication Tinlarebant, intended to treat Stargardt Disease (STGD1) in Japan. The designation will expedite the drug's approval process, enabling faster availability to patients. Positive results were observed in a 24-month Phase 2 trial, which showed reduced atrophic lesion growth in treated subjects. The company is currently conducting pivotal Phase 3 trials for both STGD1 and Geographic Atrophy (GA), with interim results expected in late 2024.
Read more →BLTEBelite Bio to Participate in the Benchmark’s 4th Annual Healthcare House Call Investor Conference
Belite Bio, Inc. (NASDAQ: BLTE) has announced its participation in the Benchmark's 4th Annual Healthcare House Call Investor Conference, which will take place virtually on May 21 and 22, 2024. The company's executive management will host a fireside chat at 3:00 pm ET on May 21. This event underscores Belite Bio's commitment to addressing the needs in the field of degenerative retinal diseases.
Read more →BLTEBelite Bio Reports First-Quarter 2024 Financial Results and Provides Corporate Update Tinlarebant is Belite Bio's orally administered tablet intended to slow disease progression in patients affected with Stargardt Diseas
Belite Bio, Inc reported its financial results for Q1 2024, highlighting a strong start with the launch of the DRAGON II trial and a successful $25 million funding round. The company shared positive data from its Phase 2 trial of Tinlarebant regarding its potential to slow disease progression in Stargardt Disease. However, despite these achievements, Belite recorded a net loss of $7.9 million for the quarter, reflecting higher research and development costs. The company aims to continue building on its momentum in developing treatments for degenerative retinal diseases.
Read more →BLTEBelite Bio to Participate in the H.C. Wainwright 2nd Annual BioConnect Investor Conference
Belite Bio, Inc. (NASDAQ: BLTE) announced its participation in the H.C. Wainwright 2nd Annual BioConnect Investor Conference on May 20, 2024, in New York. The company will host a fireside chat at 3:30 pm ET, focusing on its clinical-stage biopharmaceutical drug developments. This appearance underscores the company's ongoing efforts to advance its novel therapeutics targeting degenerative retinal diseases. A webcast of the session will be available on their investor relations page.
Read more →BLTEBelite Bio to Host Webcast on May 14, 2024, to Discuss First Quarter 2024 Financial Results
Belite Bio, a clinical-stage biopharmaceutical company, has announced it will host a webcast on May 14, 2024, to discuss its financial results for the first quarter of 2024. The webcast will occur at 4:30 p.m. Eastern Time, aiming to provide updates on the company's business activities. This initiative reflects the company's commitment to keeping stakeholders informed about its developments in addressing degenerative retinal diseases.
Read more →BLTEBelite Bio to Participate in Key Opinion Leader Webinar to Discuss Unmet Needs In Stargardt Disease (STGD1) and Geographic Atrophy (GA) and Perspectives On Tinlarebant
Belite Bio, Inc. will join a Key Opinion Leader Webinar on May 13, 2024, to discuss unmet treatment needs in Stargardt disease and Geographic Atrophy. Moderated by Jennifer Kim from Cantor Fitzgerald, the webinar will feature Dr. Michel Michaelides, a leading expert in inherited eye diseases. The discussion will cover the competitive landscape and the potential applications of Tinlarebant, a novel treatment currently in Phase 2 trials. Tinlarebant holds several designations that may aid in its expedited progress in treating these conditions.
Read more →BLTEBelite Bio Presents Additional Analysis from Phase 2 Study of Tinlarebant in Stargardt Disease at the ARVO Annual Meeting
Belite Bio has presented findings from its Phase 2 study of Tinlarebant, an oral treatment for Stargardt Disease, at the ARVO Annual Meeting. The analysis shows that 42% of patients with known ABCA4 mutations did not develop new atrophic lesions over 24 months, and the mean visual acuity loss was significantly lower than historical rates. The results utilized a novel lesion size quantification method which improved detection accuracy. Based on these promising outcomes, ongoing studies for Tinlarebant in adolescent Stargardt Disease and Geographic Atrophy are anticipated to yield further insights.
Read more →BLTEBelite Bio Announces Presentation at the Association for Research in Vision and Ophthalmology 2024 Annual Meeting
Belite Bio announced its participation in the ARVO 2024 Annual Meeting, where it will present data from a 24-month Phase 2 study on Tinlarebant, an oral therapy targeting Stargardt Disease. The study showed that 42% of treated adolescents did not develop new atrophic lesions, indicating potential efficacy. Additionally, the company has completed enrollment for a pivotal Phase 3 trial in this indication and is conducting ongoing trials for other related diseases. The presentation is scheduled for May 5, 2024, in Seattle, WA.
Read more →BLTEBelite Bio Announces $25 Million Registered Direct Offering SAN DIEGO, April 25 , 2024- Belite Bio, Inc (NASDAQ: BLTE) ("Belite Bio" or the "Company"), a clinical-stage biopharmaceutical drug development company focused
Belite Bio, a clinical-stage biopharmaceutical company, announced a $25 million registered direct offering to institutional investors. The offering comprises 651,380 American Depositary Shares (ADSs) priced at $38.38 each, along with warrants for additional shares. Proceeds will be used for clinical trials and the development of Tinlarebant and other pipeline products. The offering's completion is expected by April 30, 2024, pending standard closing conditions.
Read more →BLTEBelite Bio Announces PMDA Submission of Tinlarebant for Stargardt Disease Clinical Trial in Japan Tinlarebant is Belite Bio's orally administered tablet intended to slow disease progression in patients affected with Star
Belite Bio has announced the submission of Tinlarebant to the PMDA to initiate a clinical trial for Stargardt Disease in Japan, targeting adolescent patients. The trial, named DRAGON II, will include a Phase 1b and Phase 2/3 study, evaluating the drug's pharmacokinetics, pharmacodynamics, efficacy, and safety. This novel orally administered treatment aims to reduce harmful bisretinoid accumulation linked to retinal diseases. Belite Bio has received special designations for Tinlarebant in the U.S., marking significant progress in their effort to address STGD1.
Read more →BLTEBelite Bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update Tinlarebant is Belite Bio's orally administered tablet intended to slow disease progression in patients affected with S
Belite Bio, Inc. has announced its fourth quarter and full-year financial results for 2023, highlighting significant advancements in its clinical programs, particularly the oral therapy Tinlarebant for eye diseases. The company's cash reserves increased to $88.2 million, indicating a strong financial position as it moves forward. However, Belite reported a net loss of $31.6 million for the year, more than double the previous year's loss, underscoring rising operational costs amidst ongoing clinical trials. The company plans to share further updates from its ongoing trials in 2024.
Read more →BLTEBelite Bio to Host Webcast on March 12, 2024, to Discuss Fourth Quarter and Full Year 2024 Financial Results
Belite Bio, Inc. has announced a webcast on March 12, 2024, at 4:30 p.m. Eastern Time to discuss its financial results for the fourth quarter and full year ending December 31, 2023. The company specializes in developing therapeutics for degenerative retinal diseases. The webcast will also include a business update, highlighting the firm’s proactive approach to investor communication.
Read more →BLTEBelite Bio to Participate in the Leerink Partners Global Biopharma Conference
Belite Bio, Inc. will participate in the Leerink Partners Global Biopharma Conference from March 11-13, 2024, in Miami, FL. The company's executive management team is set to host a fireside chat on March 13 at 10:00 am ET. A webcast of this session will be available on the company's investor relations website and archived for 90 days. This engagement highlights Belite Bio's commitment to advancing therapies for retinal diseases.
Read more →BLTEBelite Bio to Present at the Oppenheimer 34th Annual Healthcare Life Sciences Conference
Belite Bio, a clinical-stage biopharmaceutical company focused on retinal disease therapeutics, will present at the Oppenheimer 34th Annual Healthcare Life Sciences Conference on February 13-14, 2024. The presentation is scheduled for February 14 at 12:40 pm ET and will be available via webcast on the company's investor relations page. A replay of the presentation will also be accessible for 90 days after the event.
Read more →BLTEBelite Bio to Participate in the Benchmark Company’s Upcoming Discovery One-on-One Investor Conference
Belite Bio, Inc. (NASDAQ: BLTE) has announced its participation in the Benchmark Company’s 12th Annual Discovery One-on-One Investor Conference, scheduled for December 7, 2023, at the New York Athletic Club. This event represents an opportunity for Belite to engage directly with investors and discuss its clinical-stage biopharmaceutical developments targeting degenerative retinal diseases. Interested investors can register for the conference and request one-on-one meetings with the company's management.
Read more →BLTEBelite Bio to Participate in the BTIG Ophthalmology Day
Belite Bio, a clinical-stage biopharmaceutical company, announced its participation in the BTIG Ophthalmology Day on November 27, 2023. The event will include a fireside chat and one-on-one meetings with investors. This initiative underscores Belite's commitment to addressing degenerative retinal diseases and engaging with the investment community.
Read more →BLTEBelite Bio Reports Third Quarter 2023 Operational Highlights and Financial Results Completed enrollment in pivotal Phase 3 "DRAGON" trial for Tinlarebant in adolescent Stargardt disease ("STGD1") with 104 subjects enroll
Belite Bio reported significant advancements in its clinical trials during the third quarter of 2023, notably completing enrollment for the pivotal Phase 3 "DRAGON" trial for Tinlarebant targeting adolescent Stargardt disease, with 104 subjects enrolled. The company also commenced dosing in the Phase 3 "PHOENIX" trial for Geographic Atrophy. Phase 2 results indicate that Tinlarebant is well tolerated and effective in slowing the progression of the disease, maintaining visual acuity in patients. However, the company warned about potential adverse tax implications for U.S. shareholders if designated as a passive foreign investment company.
Read more →BLTEBelite Bio to Host Webcast on November 14, 2023, to Discuss Third Quarter 2023 Financial Results
Belite Bio, a clinical-stage biopharmaceutical company, has announced a webcast scheduled for November 14, 2023. The event will cover the company's financial results for the third quarter of 2023, concluding on September 30. This webcast aims to provide a comprehensive business update and engage with both media and investors about the company's developments. A replay will be accessible for up to 90 days after the event.
Read more →BLTEBelite Bio Presents Results from a 24-month, Phase 2 Study of Tinlarebant in Childhood-onset Stargardt Disease at the AAO Annual Meeting Tinlarebant (a/k/a LBS-008) is Belite Bio's orally administered tablet intended to
Belite Bio has presented results from a 24-month Phase 2 study of Tinlarebant for childhood-onset Stargardt Disease at the AAO Annual Meeting. The data indicated that Tinlarebant was safe and well-tolerated, with evidence of reduced disease progression and stabilization of visual acuity in the treated adolescents. Additionally, 42% of participants did not develop retinal lesions during the study period. The company is now looking forward to seeing similar effects in their ongoing Phase 3 DRAGON study.
Read more →BLTEBelite Bio, Inc. to present at the Deutsche Bank ADR Virtual Investor Conference on 8 November 2023
Belite Bio, Inc. has announced that its Chief Scientific Officer, Nathan Mata, will present at the Deutsche Bank ADR Virtual Investor Conference on November 8, 2023. The conference aims to introduce global companies with ADR programs to investors, featuring live interaction and Q&A sessions. Belite Bio is currently focused on developing Tinlarebant, an oral medication aimed at treating severe retinal diseases with ongoing Phase 3 trials for Stargardt Disease and Geographic Atrophy. The conference participation is free, and recordings will be available for those who cannot attend live.
Read more →BLTEBelite Bio Announces Presentation at the American Academy of Ophthalmology 2023 Annual Meeting
Belite Bio, Inc. has announced that data from its Phase 1b/2 trial of Tinlarebant in adolescent Stargardt Disease will be presented at the American Academy of Ophthalmology Annual Meeting in November 2023. The company is also conducting two global Phase 3 trials targeting adolescent Stargardt Disease and Geographic Atrophy. Tinlarebant, which has received multiple designations aimed at expediting its development, specifically aims to address significant unmet medical needs for these conditions, which currently lack FDA approved treatments.
Read more →BLTEBelite Bio Reports Second Quarter 2023 Operational Highlights and Financial Results Completed enrollment in pivotal Phase 3 "DRAGON" trial for Tinlarebant in adolescent Stargardt disease ("STGD1") with 100 subjects enrol
Belite Bio, Inc. announced its financial results for Q2 2023, revealing a net loss of $6.8 million and increased research and development expenses. The company highlighted its completion of enrollment in the pivotal Phase 3 'DRAGON' trial for Tinlarebant in adolescent Stargardt disease. Positive early outcomes from the Phase 2 STGD1 trial were noted, alongside ongoing late-stage trials for GA. With a cash reserve of $57.4 million, Belite anticipates several key data readouts in the upcoming months.
Read more →BLTEBelite Bio to Host Webcast on August 9, 2023 to Discuss Second Quarter 2023 Financial Results
Belite Bio, a clinical stage biopharmaceutical company, announced it will host a webcast on August 9, 2023, to discuss its second-quarter financial results for the period ending June 30, 2023. The event will provide an update on the company's performance and offer insights into its ongoing efforts in developing therapeutics for retinal degenerative eye diseases. Interested parties can access the webcast via the provided link or the company's Investor Relations website.
Read more →BLTEBelite Bio Doses First Subject in Pivotal Phase 3 PHOENIX Trial Evaluating Oral Tinlarebant for GA
Belite Bio has initiated its pivotal Phase 3 PHOENIX trial by successfully dosing the first subject with its oral treatment, Tinlarebant, which aims to address Geographic Atrophy (GA) in patients with advanced Dry Age-related Macular Degeneration. There are currently no approved oral treatments for GA, creating a significant unmet medical need. The trial plans to enroll approximately 430 participants globally, with an interim analysis of efficacy and safety expected mid-trial. Data from a prior Phase 2 trial shows promise for Tinlarebant's ability to slow disease progression in similar conditions.
Read more →BLTEBelite Bio Completes Enrollment in Pivotal Global Phase 3 DRAGON Trial Evaluating Oral Tinlarebant for Stargardt Disease Tinlarebant (a/k/a LBS-008) is Belite Bio's orally administered tablet intended to slow disease pro
Belite Bio has completed enrollment for its pivotal global Phase 3 DRAGON trial of Tinlarebant, an oral treatment for Stargardt Disease. The study involves 90 adolescent patients from 11 countries, marking a significant milestone for the company's clinical program. Interim safety and efficacy data are anticipated in mid-2024, as Tinlarebant aims to become the first FDA-approved therapy for a disease with no existing treatments. The trial is double-blinded and placebo-controlled, focusing on slowing the rate of disease progression.
Read more →BLTEBelite Bio Announces Proposed Underwritten Public Offering of American Depositary Shares and Warrants
Belite Bio, Inc. announced a proposed underwritten public offering of American Depositary Shares and warrants to support its therapeutic developments targeting retinal degenerative diseases. The offering, which is subject to market conditions, aims to raise funds for clinical trials of its lead drug, Tinlarebant, along with other pipeline products. Belite Bio emphasized that the completion and terms of the offering are uncertain and dependent on various market factors.
Read more →BLTEBelite Bio Announces Pricing of $30 Million Underwritten Public Offering of American Depositary Shares and Warrants
Belite Bio has priced an underwritten public offering of 2,000,000 American Depositary Shares and warrants, aiming to raise $30 million. The proceeds will be allocated to clinical trials for their lead drug Tinlarebant, among other uses in research and corporate operations. Closing of the offering is expected around June 2, 2023, contingent upon standard closing conditions. The offering involves standard risks associated with the completion and regulatory approval of drug candidates.
Read more →BLTEBelite Bio Reports First-Quarter 2023 Operational Highlights and Financial Results In 18-month interim data from ongoing 2-year, Phase 2 Stargardt disease ("STGD1") trial ("LBS-008-CT02"), we continued to observe that or
Belite Bio reported operational highlights and financial results for the first quarter of 2023, revealing encouraging interim data from its ongoing Phase 2 trial of Tinlarebant for Stargardt disease, which shows potential to slow disease progression. The company has made progress with 60% enrollment in its Phase 3 DRAGON trial and anticipates enrolling the first patient in its Phase 3 PHOENIX trial mid-2023. However, financial results indicate a considerable net loss, which raises questions about sustainability as research and development costs increase significantly.
Read more →BLTEBelite Bio to Host Webcast on May 11, 2023 to Discuss First Quarter 2023 Financial Results
SAN DIEGO, May 10, 2023 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE), a clinical stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting retinal degenerative eye diseases which have significant unmet medical needs, today announced
Read more →BLTEBelite Bio to Host Key Opinion Leader Webinar Discussing Progression of Childhood-onset STGD1 and Relevance of the Tinlarebant 18-month Phase 2 Data
The webinar will take place on Wednesday, May 10, 2023 at 1:00 PM ET SAN DIEGO, May 04, 2023 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE), a clinical stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting retinal degenerative eye
Read more →BLTEBelite Bio Presented 18-Month Interim Data from a 24-Month Phase 2 Study of Tinlarebant in Adolescent Stargardt Disease at the 2023 ARVO Meeting Tinlarebant (aka LBS-008) continues to be safe and well tolerated in adoles
Belite Bio presented interim data from its 24-month Phase 2 study of Tinlarebant in adolescent patients with Stargardt Disease at the 2023 ARVO Meeting. The results indicated that Tinlarebant remains safe and well tolerated after 18 months of treatment, with no significant loss in visual acuity observed. Notably, nearly 60% of subjects showed no increase in atrophic retinal lesions, suggesting a potential for slowing disease progression. The company plans to continue its evaluation of Tinlarebant in further studies, targeting both STGD1 and Geographic Atrophy.
Read more →BLTEBelite Bio to Host Key Opinion Leader Webinar on RBP4 Antagonist Tinlarebant in Late-Stage Development for Stargardt Disease 1
Virtual event on Wednesday, May 3rd at 1:00 PM ET will feature key opinion leader Hendrik Scholl, M.D. from the University of Basel, Switzerland 18-month interim efficacy and safety data from Belite Bio’s Phase 2 trial evaluating tinlarebant in Stargardt disease 1 will be discus
Read more →BLTEBelite Bio Reports Full-Year 2022 Operational Highlights and Financial Results 12-month interim data from the ongoing 2-year, Phase 2 Stargardt disease (STGD1) study continues to show halting or slowing of lesion growth;
Belite Bio announced its financial results for 2022 and shared significant operational highlights, including successful IPO and positive Phase 2 data for its Stargardt disease treatment, tinlarebant. The company is advancing its pivotal Phase 3 DRAGON trial and plans to present key efficacy and safety data at the upcoming ARVO meeting. Despite the optimistic results, Belite faced increased losses and rising costs in research and administration, indicating financial challenges. The company remains focused on developing therapies for eye diseases with unmet needs.
Read more →BLTEBelite Bio Reports Full-Year 2022 Operational Highlights and Financial Results
12-month interim data from the ongoing 2-year, Phase 2 Stargardt disease (STGD1) study continues to show halting or slowing of lesion growth; 18-month efficacy and safety update expected during the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting on
Read more →BLTEBelite Bio to Host Webcast on April 3, 2023 to Discuss 2022 Full Year Financial Results
SAN DIEGO, March 31, 2023 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE), a San Diego based clinical stage biopharmaceutical drug development company targeting eye diseases with significant unmet medical needs, will host a live webcast on Monday, April 3, 2023, at 4:30 p.m. E
Read more →BLTEBelite Bio Finalizes Phase 3 Clinical Trial Plans for Advanced Dry AMD Treatment with Tinlarebant (LBS-008) Tinlarebant (a/k/a LBS-008) is Belite Bio's orally administered tablet intended as an early intervention to slow
Belite Bio Finalizes Phase 3 Clinical Trial Plans for Advanced Dry AMD Treatment with Tinlarebant (LBS-008) SAN DIEGO, Nov 18, 2022- Belite Bio, Inc (NASDAQ: BLTE), a San Diego based clinical stage biopharmaceutical drug development company targeting currently untreatable eye
Read more →BLTEBelite Bio to Host Key Opinion Leader Webinar on October 27, 2022 to discuss LBS-008 Interim Data
“Potential Early Intervention with an Oral Treatment for Stargardt Disease and Dry Age-Related Macular Degeneration” Thursday, October 27th at 11 AM ET SAN DIEGO, Oct. 20, 2022 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE), a San Diego based clinical stage biopharmaceutica
Read more →BLTEBelite Bio Presented 12-Month Interim Results of LBS-008 Phase 1b/2 Study in Adolescent Stargardt Disease at AAO Annual Meeting 2022 LBS-008 (aka Tinlarebant) was safe and well tolerated in adolescent Stargardt Disease (
Belite Bio Presented 12-Month Interim Results of LBS-008 Phase 1b/2 Study in Adolescent Stargardt Disease at AAO Annual Meeting 2022 SAN DIEGO, October 1, 2022- Belite Bio, Inc (NASDAQ: BLTE), a San Diego based clinical stage biopharmaceutical drug development company targetin
Read more →BLTEBelite Bio Announces Late-Breaking Presentation at the American Academy of Ophthalmology 2022 Annual Meeting
1-year interim data from the 2-year Phase 1b/2 trial of LBS-008 in adolescent STGD1 to be presented SAN DIEGO, Sept. 23, 2022 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE), a San Diego based clinical stage biopharmaceutical drug development company targeting currently untre
Read more →BLTEBelite Bio Receives Approval of LBS-008 Phase 3 Clinical Trial in China LBS-008 (aka Tinlarebant) is Belite Bio's orally administered tablet for early intervention to maintain the health of retinal tissue in Stargardt di
Belite Bio Receives Approval of LBS-008 Phase Clinical Trial in China LBS-008 (aka Tinlarebant) is Belite Bio's orally administered tablet for early intervention to maintain the health of retinal tissue in Stargardt disease (STGD1) and Dry AMD patients A 2-year Phase 2 tria
Read more →BLTEBelite Bio Initiates Pivotal Phase 3 Clinical Trial of LBS-008 in Stargardt Disease in the U.S. - LBS-008 (aka Tinlarebant) is Belite Bio's orally administered tablet for the treatment of Stargardt disease (STGD1) and Dr
Belite Bio Initiates Pivotal Phase 3 Clinical Trial of LBS-008 in Stargardt Disease in the U.S. August 22, 2022- Belite Bio, Inc (NASDAQ: BLTE), a San Diego based clinical stage biopharmaceutical drug development company targeting currently untreatable eye diseases, today ann
Read more →BLTEBelite Bio Reports First Half 2022 Operational Highlights and Financial Results - LBS-008 (aka Tinlarebant) is Belite Bio's orally administered tablet for the treatment of Stargardt disease (STGD1) and Dry AMD - A 2-year
Belite Bio Reports First Half 2022 Operational Highlights and Financial Results - LBS-008 (aka Tinlarebant) is Belite Bio's orally administered tablet for the treatment of Stargardt disease (STGD1) and Dry AMD - A 2-year Phase 2 trial in adolescent STGD1 and a global Phase 3
Read more →BLTEBelite Bio to Host Conference Call on August 11, 2022 to Discuss First Half 2022 Financial Results
SAN DIEGO, Aug. 01, 2022 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE), a San Diego based clinical stage biopharmaceutical drug development company targeting untreatable eye diseases, will host a conference call on Thursday, August 11, 2022, at 4:30 p.m. Eastern time to disc
Read more →BLTEBelite Bio Submits Investigational New Drug
Belite Bio Submits Investigational New Drug (IND) Application to FDA for Approval to Proceed with LBS-008 Phase 3 Clinical Trial for the Treatment of Stargardt Disease SAN DIEGO, July 19, 2022 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) ("Belite" or the "Company"), a Sa
Read more →BLTEBelite Bio Submits Investigational New Drug (IND) Application to FDA for Approval to Proceed with LBS-008 Phase 3 Clinical Trial for the Treatment of Stargardt Disease
LBS-008 (a/k/a Tinlarebant) is the Company’s orally administered tablet for the treatment of Stargardt disease (STGD1) There are currently no approved treatments for STGD1 Approximately 30,000 patients in the U.S. suffer from STGD1 A 2-year Phase 2 trial in adolescent STGD1 an
Read more →BLTEBelite Bio Announces Partial Exercise of Over-Allotment Option in Initial Public Offering
Bio Announces Partial Exercise of Over-Allotment Option in Initial Public Offering DIEGO, Calif., May 12, 2022--(GLOBE NEWSWIRE)-Belite Bio, Inc (NASDAQ: BLTE) ("Belite" or the "Company"), a clinical stage biopharmaceutical drug development company targeting currently untreatab
Read more →BLTEBelite Bio Presented Interim Results of LBS-008 Phase 1b/2 Study in Adolescent STGD1 at ARVO Annual Meeting 2022
LBS-008 (aka Tinlarebant) showed an acceptable safety profile in adolescent Stargardt disease (STGD1) subjects A trend for stabilized or improved visual acuity was observed Observed adverse events were anticipated based on the mechanism of LBS-008 action STGD1 subjects from th
Read more →BLTEBelite Bio Receives FDA Fast Track Designation For LBS-008 - LBS-008 (aka Tinlarebant) is the Company's orally administered tablet for the treatment of Stargardt disease (STGD1) - There are currently no approved treatmen
Belite Bio Receives FDA Fast Track Designation May 3, 2022- Belite Bio, Inc (the "Company") (Nasdaq: BLTE), a San Diego based clinical stage biopharmaceutical drug development company targeting currently untreatable eye diseases, such as atrophic Age-related Macular Degeneratio
Read more →BLTEBelite Bio Announces Closing of $36 Million Initial Public Offering
SAN DIEGO, May 03, 2022 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite” or the “Company”), a clinical stage biopharmaceutical drug development company targeting currently untreatable eye diseases such as dry AMD and Stargardt disease, and metabolic diseases, today an
Read more →BLTEBelite Bio Announces Pricing of $36 Million Initial Public Offering
SAN DIEGO, April 28, 2022 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite” or the “Company”), a clinical stage biopharmaceutical drug development company targeting currently untreatable eye diseases such as dry AMD and Stargardt disease, and metabolic diseases, today
Read more →Competitive Position
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