SAN DIEGO, Feb. 23, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that it will host a webcast on Monday, March 2, 2026, at 4:30 p.m. Eastern Time to discuss the Company’s financial results and provide a business update for the fourth quarter and full year ended December 31, 2025. Webcast InformationDate: Monday, March ...

Core Insights - Belite Bio, Inc is participating in the Asia-Pacific Academy of Ophthalmology (APAO) 2026 Congress to present findings related to its drug tinlarebant for Stargardt disease type 1 (STGD1) [1][2] Company Overview - Belite Bio is a clinical-stage drug development company focused on novel therapeutics for degenerative retinal diseases, including STGD1 and geographic atrophy (GA) in advanced dry age-related macular degeneration (AMD) [8] - The lead candidate, tinlarebant, is designed to reduce the accumulation of bisretinoid toxins in the eye, which are linked to retinal diseases [8] Upcoming Presentations - The company will present topline results from the Phase 3 DRAGON study of tinlarebant for adolescents with STGD1 during the APAO Congress [2][3] - An oral presentation is scheduled for February 6, 2026, and a sponsored lunch symposium will take place on February 7, 2026 [3] Exhibition Details - Belite Bio will have an exhibition booth at the APAO Congress from February 5-7, 2026, located at Hall 5E, Booth 5E-C03 [4] About Tinlarebant - Tinlarebant is an oral therapy that aims to reduce vitamin A-based toxins causing retinal disease in STGD1 and contributes to disease progression in GA [4] - The drug has received multiple designations, including Breakthrough Therapy and Fast Track in the U.S., and Orphan Drug Designation in the U.S., Europe, and Japan [4] About Stargardt Disease Type 1 (STGD1) - STGD1 is the most common inherited macular dystrophy, leading to central vision loss due to mutations in the ABCA4 gene [5] - There are currently no FDA-approved treatments for STGD1, highlighting the unmet medical need in this area [5]

Core Insights - Belite Bio has completed enrollment of 60 subjects in the Phase 2/3 DRAGON II clinical trial for tinlarebant, targeting Stargardt disease type 1 (STGD1) [1][2][7] - The trial is a global, 24-month, randomized, double-masked, placebo-controlled study involving participants aged 12 to 20 years from Japan, the United States, and the United Kingdom [2] - The company plans to submit a New Drug Application (NDA) to the FDA for tinlarebant in the first half of 2026 [3][7] Clinical Trial Details - The DRAGON II trial aims to evaluate the efficacy, safety, and tolerability of tinlarebant in adolescent patients with STGD1 [2] - Participants are randomized 1:1 to receive either tinlarebant or placebo [2] - The completion of enrollment reflects strong engagement from the Stargardt disease community [3] Drug Information - Tinlarebant is an oral therapy designed to reduce the accumulation of vitamin A-based toxins (bisretinoids) that cause retinal disease in STGD1 [4] - The drug works by modulating serum retinol binding protein 4 (RBP4) levels, thereby reducing bisretinoid formation [4] - Tinlarebant has received multiple designations, including Breakthrough Therapy Designation and Fast Track Designation in the U.S. [4] Company Overview - Belite Bio focuses on developing novel therapeutics for degenerative retinal diseases and specific metabolic diseases [5] - The company has completed a Phase 3 trial (DRAGON) in adolescent STGD1 subjects and is also evaluating tinlarebant in a Phase 3 trial (PHOENIX) for geographic atrophy [5] - The company is committed to advancing research for adolescents with Stargardt disease globally [3]

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]