SAN DIEGO, Jan. 29, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that the Company will participate in the upcoming Asia-Pacific Academy of Ophthalmology (APAO) 2026 Congress, taking place February 5-7, 2026 in Hong Kong. The presentations will include previously disclosed topline result ...

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 KingdomBelite 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) -- Be ...

Core Viewpoint - Belite Bio, Inc has announced a public offering of 2,272,727 American Depositary Shares (ADSs) at a price of $154.00 per ADS, aiming to raise approximately $350 million for commercialization and pipeline development [1][2]. Group 1: Offering Details - The public offering consists of 2,272,727 ADSs priced at $154.00 each, with an additional option for underwriters to purchase up to 340,909 more ADSs [1]. - The expected gross proceeds from the offering are approximately $350 million before deducting underwriting discounts and commissions [1]. - The closing of the offering is anticipated to occur around December 3, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be allocated for commercialization preparation, including building an in-house commercialization team and establishing sales networks [2]. - Funds will also be used for the development and expansion of the company's drug pipeline [2]. - Additional proceeds will support working capital and other general corporate purposes [2]. Group 3: Company Overview - Belite Bio is focused on developing novel therapeutics for degenerative retinal diseases with significant unmet medical needs, such as Stargardt disease type 1 and geographic atrophy in advanced dry age-related macular degeneration [6]. - The company's lead candidate, Tinlarebant, is an oral therapy aimed at reducing bisretinoid toxins in the eye and has completed a Phase 3 trial in adolescent STGD1 subjects [6].

Core Viewpoint - Belite Bio is experiencing positive market sentiment due to the successful results of its experimental drug for a rare genetic eye disease, leading to a new price target set by H.C. Wainwright, indicating potential growth in the company's market performance [1][2][5] Company Performance - Belite Bio's stock is currently priced at $147.01, reflecting a 6.96% increase following the positive trial results [3][5] - The stock has shown significant volatility, with a trading range between $130.06 and $159.71, and a yearly high of $154.99 and a low of $49 [3] - The company's market capitalization is approximately $5.13 billion, indicating a substantial presence in the biopharmaceutical industry [4] Market Sentiment - H.C. Wainwright has set a new price target of $185 for Belite Bio, representing a 20.4% potential upside from its current trading price [1][5] - The positive trial results and the new price target have likely driven active investor interest, as evidenced by a trading volume of 651,051 shares [4]

Core Viewpoint - Belite Bio is nearing the commercialization of its leading drug candidate, tinlarebant, following positive results from a phase 3 trial, which significantly boosted its stock price by 12% [1][2]. Group 1: Drug Candidate and Trial Results - Tinlarebant met its primary endpoint in a phase 3 trial aimed at treating adolescents with Stargardt disease, a condition that can lead to loss of central vision [2][4]. - The drug demonstrated a nearly 36% reduction in lesion growth compared to a placebo, indicating its efficacy in slowing the progression of the disease [3]. - Minimal change in visual acuity was recorded after 24 months, further supporting the drug's potential [3]. Group 2: Company Statements and Future Plans - CEO Tom Lin highlighted that tinlarebant is the first oral treatment to show a clinically meaningful outcome in retinal degenerative disease [4]. - Belite Bio plans to submit New Drug Applications for tinlarebant in the first half of next year, indicating a proactive approach towards regulatory approval [4]. Group 3: Market Reaction and Financial Data - Following the announcement, Belite Bio's stock price rose to $16.58, reflecting a market capitalization of $5 billion [5]. - The stock's trading range for the day was between $130.06 and $154.99, with a 52-week range of $49.00 to $154.99 [6].

Core Viewpoint - Belite Bio Inc. has received a stock upgrade to "Buy" with a price target increase, driven by positive trial results for its drug Tinlarebant targeting a rare eye disease [1][5]. Group 1: Stock Performance - H.C. Wainwright upgraded Belite Bio's stock from a price target of $98 to $185, reflecting strong market sentiment [1][5]. - Following the successful trial results, the stock price rose to approximately $153.59, marking an increase of about 11.75% or $16.15 [4]. - The stock has fluctuated between $130.06 and $154.99, with the latter being its highest price in the past year [4]. - Belite Bio's market capitalization is approximately $5.36 billion, with a trading volume of 596,581 shares, indicating strong investor interest [4]. Group 2: Clinical Trial Results - The Phase 3 DRAGON trial for Tinlarebant demonstrated a 36% reduction in lesion growth compared to placebo, marking a significant milestone for treating Stargardt disease type 1 (STGD1) [2][5]. - The trial enrolled 104 patients and is noted as the first successful pivotal trial for STGD1, a rare eye disease causing progressive vision loss [2]. Group 3: Future Plans - Belite Bio plans to file a New Drug Application (NDA) with the FDA in the first half of 2026, which is a crucial step towards commercialization [3][5]. - Tinlarebant works by lowering serum retinol binding protein 4 (RBP4) levels, thereby reducing harmful bisretinoids in the eye, offering hope for over 50,000 STGD1 patients in the U.S. [3].

Core Viewpoint - Belite Bio, Inc has initiated an underwritten public offering of American Depositary Shares (ADSs) to support its commercialization and development efforts in the field of degenerative retinal diseases [1][2] Group 1: Offering Details - The public offering consists of ADSs, each representing one ordinary share, with all securities being sold by Belite Bio [1] - The company plans to grant underwriters a 30-day option to purchase additional ADSs at the public offering price, subject to market conditions [1] - The offering is contingent on market conditions, and there is no assurance regarding its completion or the actual size and terms [1] Group 2: Use of Proceeds - Net proceeds from the offering will be allocated for commercialization preparation, including building an in-house commercialization team and establishing sales networks [2] - Funds will also be used for the development and expansion of the company's pipelines [2] - Additional proceeds will support working capital and other general corporate purposes [2] Group 3: Company Overview - Belite Bio is focused on developing novel therapeutics for degenerative retinal diseases with significant unmet medical needs, such as Stargardt disease type 1 and geographic atrophy in advanced dry age-related macular degeneration [6] - The lead candidate, Tinlarebant, is an oral therapy aimed at reducing the accumulation of bisretinoid toxins in the eye and has completed a Phase 3 trial in adolescent STGD1 subjects [6] - The company is currently evaluating Tinlarebant in a Phase 2/3 trial and a Phase 3 trial for different indications [6]

Core Insights - Belite Bio presented topline data from its Phase III trial of Tinlarebant for Stargardt disease, known as the DRAGON study, which is the largest interventional trial conducted in adolescent patients with this condition [2] Group 1: Study Overview - The DRAGON study is a pivotal 2-year trial focusing on the efficacy of Tinlarebant in treating Stargardt disease [2] - The trial involved a significant number of adolescent patients, highlighting its scale and importance in the field of retinal diseases [2] Group 2: Leadership and Expertise - The conference call featured key executives from Belite Bio, including Dr. Tom Lin (Chairman and CEO) and Dr. Hendrik Scholl (Chief Medical Officer), who provided insights into the study [4] - Dr. Hendrik Scholl, a notable figure in retinal disease research, served as the coordinating principal investigator for the ProgStar Study, adding credibility to the DRAGON study [4]

Core Insights - Belite Bio Inc. announced successful topline results from the Phase 3 DRAGON trial of Tinlarebant for treating Stargardt disease type 1 (STGD1), marking a significant milestone in the development of therapies for this condition [1] Group 1: Trial Results - The Phase 3 DRAGON trial enrolled 104 patients and demonstrated a statistically significant reduction in lesion growth rate of 35.7% compared to placebo (p-value of 0.0033) [3] - A treatment effect was also observed in the fellow eye, with a 33.6% reduction in lesion growth (p = 0.041) [3] - Tinlarebant slowed decreased autofluorescence (DAF) lesion growth by 33.7% in the study eye (p = 0.027) and 32.7% in the fellow eye (p = 0.017) [4] Group 2: Mechanism of Action - Tinlarebant reduces the accumulation of vitamin A-based toxins (bisretinoids) by modulating retinol transport to the eye, specifically by reducing serum retinol binding protein 4 (RBP4) levels [2] - The 5 mg daily dose achieved an approximate 80% reduction in RBP4 levels relative to baseline, with levels returning to 84% of baseline at the end of the study [4] Group 3: Safety and Future Plans - The safety profile of Tinlarebant was consistent with previous reports, with only four treatment-related discontinuations noted [6] - The company plans to engage regulatory authorities and submit New Drug Applications for Tinlarebant in the first half of 2026 [6] Group 4: Market Reaction - Following the announcement, Belite Bio Inc.'s stock rose by 11.3%, reaching $153.05 during premarket trading [6]

Summary of Belite Bio's Phase Three DRAGON Study Conference Call Company and Industry - **Company**: Belite Bio - **Industry**: Biotechnology, specifically focusing on treatments for retinal diseases, particularly Stargardt disease Core Points and Arguments 1. **Study Overview**: The DRAGON Study is a phase three trial evaluating Tinlarebant for treating Stargardt disease, the largest interventional trial conducted in adolescent patients with this condition [2][4][6] 2. **Significant Results**: Tinlarebant demonstrated a statistically significant and clinically meaningful reduction in the annualized rate of lesion growth in Stargardt disease, achieving a treatment effect size of 36% compared to placebo [17][24] 3. **Mechanism of Action**: Tinlarebant is an orally administered small molecule that targets retinal binding protein 4 (RBP4) to reduce vitamin A delivery to the eye, thereby slowing disease progression [5][24] 4. **Patient Impact**: The slowing of lesion growth is expected to lead to a longer preservation of vision, allowing patients to maintain daily activities longer [26][32] 5. **Safety Profile**: The treatment maintained an excellent safety and tolerability profile over the two-year study period, with no serious treatment-related adverse events reported [22][23][33] 6. **Regulatory Pathway**: Belite Bio plans to submit the full data package to regulatory agencies, with confidence that the DDAF (definitely decreased autofluorescence) endpoint will be accepted for approval [41][48] Additional Important Content 1. **Epidemiology**: Stargardt disease affects approximately 53,000 people in the U.S. and over 100,000 in Europe and China, making it one of the most prevalent inherited retinal diseases [8][57] 2. **Visual Acuity Findings**: Best-corrected visual acuity did not show significant changes over the study duration, which aligns with the natural history of Stargardt disease [20][21] 3. **Fellow Eye Data**: Statistically significant treatment effects were also observed in the fellow eye, providing strong confirmatory evidence for the treatment's efficacy [18][52] 4. **Market Potential**: The estimated patient population for Stargardt disease is around 50,000 in the U.S., with expectations of increased diagnosis rates following the introduction of a treatment [56][57] 5. **Future Directions**: The company aims to transform the management of Stargardt disease by shifting focus to earlier diagnosis and treatment, potentially before significant vision loss occurs [35][36] This summary encapsulates the key findings and implications from the conference call regarding Belite Bio's Tinlarebant and its potential impact on the treatment of Stargardt disease.