Belite Bio Completes Enrollment in the DRAGON II Clinical Trial of Tinlarebant for Stargardt Disease (STGD1)

Rhea-AI Summary

Belite Bio (NASDAQ: BLTE) announced completion of enrollment in the Phase 2/3 DRAGON II trial of tinlarebant for Stargardt disease type 1 (STGD1). The global, 24-month, randomized, double-masked, placebo-controlled study enrolled 60 adolescent subjects (ages 12–20) across Japan, the United States, and the United Kingdom, including 15 Japanese subjects. Tinlarebant previously met the primary endpoint in the pivotal Phase 3 DRAGON trial with a 36% reduction in lesion growth (p=0.0033). Belite Bio said it remains on track to file a NDA with the FDA in 1H 2026 and designed DRAGON II to align with PMDA requirements to support potential approval in Japan.

Positive

• Phase 3 DRAGON showed 36% reduction in lesion growth (p=0.0033)
• DRAGON II achieved target enrollment of 60 adolescents
• DRAGON II includes 15 Japanese subjects to support PMDA alignment
• Company plans to file a NDA in 1H 2026

Negative

• None.

News Market Reaction – BLTE

+3.00%

2 alerts

+3.00% News Effect

+$186M Valuation Impact

$6.38B Market Cap

0.2x Rel. Volume

On the day this news was published, BLTE gained 3.00%, reflecting a moderate positive market reaction. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $186M to the company's valuation, bringing the market cap to $6.38B at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Lesion growth reduction: 36% P-value: p=0.0033 DRAGON II enrollment: 60 adolescent subjects +5 more

8 metrics

Lesion growth reduction 36% Primary endpoint in pivotal Phase 3 DRAGON trial (Stargardt disease)

P-value p=0.0033 Statistical significance for lesion growth reduction in DRAGON

DRAGON II enrollment 60 adolescent subjects Phase 2/3 DRAGON II trial in STGD1 across Japan, US, UK

Japanese subjects 15 subjects Subset of DRAGON II enrollment supporting Japan PMDA pathway

Study duration 24 months Global randomized, double-masked, placebo-controlled DRAGON II design

Age range 12–20 years Adolescent STGD1 population in DRAGON II

Randomization ratio 1:1 Tinlarebant vs placebo allocation in DRAGON II

Planned NDA timing 1H 2026 Company plan to file NDA with U.S. FDA for tinlarebant

Market Reality Check

Price: $180.95 Vol: Volume 427,064 vs 20-day ...

high vol

$180.95 Last Close

Volume Volume 427,064 vs 20-day average 231,618 (relative volume 1.84) ahead of the news. high

Technical Shares at $162.47, trading above 200-day MA of $88.72 and 7.04% below the 52-week high.

Peers on Argus

BLTE was down 1.28% pre-news while only one scanned peer (IBRX) showed momentum,...

1 Down

BLTE was down 1.28% pre-news while only one scanned peer (IBRX) showed momentum, moving -4.51% without news, suggesting a stock-specific setup rather than a broad biotech move.

Previous Clinical trial Reports

5 past events · Latest: Dec 01 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 01	Phase 3 topline data	Positive	+12.1%	Positive Phase 3 DRAGON topline data with 35.7% lesion-growth reduction and strong stats.
Oct 15	Regulatory trial update	Positive	+2.5%	China NMPA agreed to NDA with priority review based on DRAGON interim results.
Sep 12	Trial completion	Positive	+1.4%	Completion of pivotal Phase 3 DRAGON trial in STGD1 with 104 adolescents enrolled.
Jul 02	GA trial enrollment	Positive	-0.6%	Completion of enrollment in Phase 3 PHOENIX GA trial with 500 subjects globally.
Feb 27	Interim trial results	Positive	+5.0%	Interim DRAGON analysis showed good tolerability and stable visual acuity, DSMB backed continuation.

Pattern Detected

Clinical-trial news for Tinlarebant has typically seen positive price reactions, with only one mild divergence despite generally favorable updates.

Recent Company History

Over the past year, Belite Bio has repeatedly advanced Tinlarebant in Stargardt disease and geographic atrophy. Key milestones include completion of the pivotal Phase 3 DRAGON trial with 104 subjects, interim and topline data showing statistically significant lesion-growth reduction, and completion of enrollment in the PHOENIX GA trial with 500 subjects. Several updates flagged plans to file NDAs in 1H 2026. Today’s DRAGON II enrollment completion in adolescent STGD1 aligns with this progression of late-stage clinical execution.

Historical Comparison

+4.3% avg move · In the past 12 months, BLTE reported 5 clinical-trial updates with an average move of 4.3%. Today’s ...

clinical trial

+4.3%

Average Historical Move clinical trial

In the past 12 months, BLTE reported 5 clinical-trial updates with an average move of 4.3%. Today’s DRAGON II enrollment news fits the pattern of steady, execution-driven catalysts.

Clinical updates show a clear path: interim DRAGON data, trial completion, regulatory acceptance, positive Phase 3 topline results, and now completion of DRAGON II enrollment in adolescent STGD1.

Market Pulse Summary

This announcement highlights completion of enrollment in the global Phase 2/3 DRAGON II trial for ad...

Analysis

This announcement highlights completion of enrollment in the global Phase 2/3 DRAGON II trial for adolescent Stargardt disease, reinforcing Tinlarebant’s late-stage development and a planned NDA filing in 1H 2026. Prior DRAGON data showed statistically significant lesion-growth reduction in STGD1. Historically, clinical-trial updates produced moderate average moves of 4.3%. Key factors to watch include DRAGON II readouts, alignment with earlier efficacy signals, and subsequent regulatory feedback in the U.S. and Japan.

Key Terms

stargardt disease, new drug application, nda, u.s. food and drug administration, +4 more

8 terms

stargardt disease medical

"Tinlarebant is the first therapeutic candidate to demonstrate clinical efficacy in Stargardt disease"

A hereditary eye disorder that gradually destroys the macula, the small central part of the retina responsible for sharp, straight‑ahead vision; imagine the center of a camera sensor losing pixels so faces and words become blurred while peripheral sight stays. It matters to investors because it defines the size and urgency of the market for new drugs, gene therapies and diagnostics, shapes clinical trial design and regulatory risk, and influences potential future revenue and valuation for companies developing treatments.

new drug application regulatory

"Belite Bio plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

nda regulatory

"Belite Bio plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration"

An NDA, or nondisclosure agreement, is a legal contract that keeps certain information private between parties. It’s like a promise not to share sensitive details, helping protect business ideas, strategies, or data from being leaked or used without permission. For investors, NDAs help ensure that confidential information remains secure, enabling trust and open communication during business discussions.

u.s. food and drug administration regulatory

"Belite Bio plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA)"

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

randomized technical

"24-month, randomized, double-masked, placebo-controlled study designed to evaluate the efficacy"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

double-masked technical

"24-month, randomized, double-masked, placebo-controlled study designed to evaluate the efficacy"

Double-masked describes a clinical study setup where neither the people receiving treatments nor the researchers who administer or assess them know who gets the active therapy versus a placebo or comparison. This reduces conscious or unconscious bias and makes results more reliable for regulators and doctors. For investors, double-masked trials carry more credibility—like a taste test where neither the tasters nor the servers know which sample is which—so positive outcomes and approvals are taken more seriously.

placebo-controlled technical

"24-month, randomized, double-masked, placebo-controlled study designed to evaluate the efficacy"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

pharmaceuticals and medical devices agency regulatory

"aligns with the requirements of the Japanese Pharmaceuticals and Medical Devices Agency (PMDA)"

A pharmaceuticals and medical devices agency is a government or independent regulator that reviews, approves and monitors medicines and medical devices to ensure they are safe, work as intended and meet quality standards. Investors care because its decisions control whether and when products can be sold, affect development costs, timelines and legal risk, and therefore have a direct impact on a company’s future revenue and valuation—much like a building inspector who must sign off before occupancy.

AI-generated analysis. Not financial advice.

• Tinlarebant is the first therapeutic candidate to demonstrate clinical efficacy in Stargardt disease, having met the primary endpoint in the pivotal, global Phase 3 DRAGON trial with 36% reduction in lesion growth (p-value=0.0033)
• 60 adolescent STGD1 subjects enrolled in DRAGON II clinical trial across Japan, the United States, and the United Kingdom
• Belite Bio plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in 1H 2026
  
  

SAN DIEGO, Jan. 27, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced the completion of enrollment of 60 subjects, including 15 Japanese subjects, in the Phase 2/3 DRAGON II clinical trial evaluating tinlarebant for the treatment of Stargardt disease type 1 (STGD1).

DRAGON II clinical trial is a global, 24-month, randomized, double-masked, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of tinlarebant in adolescent patients with STGD1. The trial had a targeted enrollment of 60 adolescent subjects aged 12 to 20 years old across Japan, the United States, and the United Kingdom, with participants randomized 1:1 to receive either tinlarebant or placebo.

“We are pleased to complete enrollment in the DRAGON II clinical trial and sincerely thank the investigators, the adolescent participants, and their families who made this study possible,” said Dr. Tom Lin, Chairman and CEO of Belite Bio. “Their commitment reflects the strong engagement of the Stargardt disease community and supports our broader clinical development and commercialization efforts. Importantly, we remain on track to submit an NDA to the FDA for tinlarebant in the first half of 2026.”

“Completing enrollment in DRAGON II clinical trial represents continued execution of our tinlarebant clinical development program,” said Dr. Hendrik Scholl, Chief Medical Officer of Belite Bio. “We are pleased to have implemented a registration-enabling study that aligns with the requirements of the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), supporting Belite Bio’s ability to pursue potential approval in Japan while advancing research for adolescents living with Stargardt disease globally.”

About Tinlarebant (a/k/a LBS-008)

Tinlarebant is a novel oral therapy that is intended to reduce the accumulation of vitamin A-based toxins (known as bisretinoids) that cause retinal disease in STGD1 and also contribute to disease progression in geographic atrophy (GA), or advanced dry age-related macular degeneration (AMD). Bisretinoids are by-products of the visual cycle, which is dependent on the supply of vitamin A (retinol) to the eye. Tinlarebant works by reducing and maintaining levels of serum retinol binding protein 4 (RBP4), the sole carrier protein for retinol transport from the liver to the eye. By modulating the amount of retinol entering the eye, tinlarebant reduces the formation of bisretinoids. Tinlarebant has been granted Breakthrough Therapy Designation, Fast Track Designation, and Rare Pediatric Disease Designation in the U.S., Orphan Drug Designation in the U.S., Europe, and Japan, and Sakigake Designation in Japan for the treatment of STGD1.

About Belite Bio

Belite Bio is a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical need, such as Stargardt disease type 1 (STGD1) and geographic atrophy (GA) in advanced dry AMD, in addition to specific metabolic diseases. Belite Bio’s lead candidate, tinlarebant, is an oral therapy intended to reduce the accumulation of bisretinoid toxins in the eye. The Company has completed a Phase 3 trial (DRAGON) in adolescent STGD1 subjects and is currently being evaluated in a Phase 2/3 trial (DRAGON II) in adolescent STGD1 subjects and a Phase 3 trial (PHOENIX) in subjects with GA. For more information, follow us on X, Instagram, LinkedIn, and Facebook or visit us at www.belitebio.com.

Important Cautions Regarding Forward Looking Statements

This press release contains forward-looking statements regarding future expectations, plans and prospects, as well as other statements regarding matters that are not historical facts. These statements include, but are not limited to, statements regarding the potential implications of clinical data for patients, and Belite Bio's advancement of, and anticipated preclinical activities, clinical development, regulatory milestones, and commercialization of its product candidates, the ability of Tinlarebant to treat STGD1 and GA, the timing to complete relevant clinical trials and/or to receive the interim/final data of such clinical trials; the timing to submit trial data to regulatory authorities for drug approval, as well as any other statements regarding matters that are not historical facts, and any other statements containing the words “expect”, “will”, “believe”, “target”, “plan,” and other similar expressions. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors related to Belite Bio’s business, including but not limited to Belite Bio’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; expectations for the timing of initiation, enrollment and completion of, and data relating to, its clinical trials; the timing to complete any ancillary clinical trials and/or to receive the interim/final data of such clinical trials; the timing to communicate with and submit trial data to regulatory authorities in various jurisdictions for drug approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Belite Bio’s drug candidates; timing for Belite Bio to share additional data at upcoming medical meetings; the potential efficacy of Tinlarebant to set a new benchmark for future research in inherited retinal disorders, as well as those risks more fully discussed in the “Risk Factors” section in Belite Bio’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Belite Bio, and Belite Bio undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

Media and Investor Relations Contact:
Jennifer Wu / ir@belitebio.com
Sophie Hunt / belite@argotpartners.com 

FAQ

What did Belite Bio announce about the DRAGON II trial for tinlarebant (BLTE)?

Belite Bio completed enrollment of 60 adolescent subjects in the Phase 2/3 DRAGON II trial across Japan, the US, and the UK.

How many subjects and what ages are enrolled in DRAGON II (BLTE)?

The trial enrolled 60 subjects aged 12–20 years, randomized 1:1 to tinlarebant or placebo.

What clinical evidence supports tinlarebant for Stargardt disease (BLTE)?

Tinlarebant met the Phase 3 DRAGON primary endpoint with a 36% reduction in lesion growth (p=0.0033).

When does Belite Bio plan to file an NDA for tinlarebant (BLTE)?

Belite Bio stated it is on track to submit a NDA to the FDA in 1H 2026.

Does DRAGON II support regulatory filings in Japan for tinlarebant (BLTE)?

Yes; DRAGON II was implemented to align with PMDA requirements and includes Japanese subjects to support potential approval.