Welcome to our dedicated page for Belite Bio news (Ticker: BLTE), a resource for investors and traders seeking the latest updates and insights on Belite Bio stock.
Stay informed about the latest developments from Belite Bio Inc, a clinical-stage biopharmaceutical company advancing novel oral therapies for retinal degenerative diseases and metabolic disorders. This news feed aggregates press releases, regulatory announcements, clinical trial updates, and market-moving events related to BLTE stock and the company's drug development programs.
Belite Bio focuses on developing treatments for conditions with significant unmet medical needs, including Stargardt disease type 1 (the most common inherited retinal dystrophy) and geographic atrophy (advanced dry age-related macular degeneration). The company's lead product candidate, Tinlarebant, represents a first-in-class oral RBP4 antagonist designed to reduce the accumulation of toxic bisretinoids that cause progressive vision loss in these blinding conditions.
Key news topics covered include clinical trial results and milestones for Tinlarebant in Stargardt disease and geographic atrophy patient populations, regulatory designations and approvals from the FDA and international health authorities, pipeline updates related to LBS-009 for metabolic diseases, corporate partnerships and licensing agreements, equity financing and capital markets activities, scientific presentations at ophthalmology and biotechnology conferences, and intellectual property developments protecting the company's anti-RBP4 platform technology.
Investors and patients following Belite Bio should pay particular attention to announcements regarding pivotal trial readouts, regulatory submission timelines, and commercialization strategies for Tinlarebant. The company has received multiple regulatory designations including Orphan Drug, Fast Track, and Breakthrough Therapy status, which may accelerate development timelines and facilitate market entry. As a clinical-stage company with no marketed products, news flow typically centers on clinical data releases, regulatory interactions, and funding activities that support advancement of the pipeline.
The company's expansion beyond ophthalmology into metabolic diseases with LBS-009 represents a strategic diversification that leverages the established safety and pharmacology of RBP4 modulation. News regarding preclinical data, investigational new drug applications, and early-stage clinical development of this program may signal long-term value creation opportunities in large patient populations affected by liver disease, diabetes, and metabolic syndrome.
Belite Bio (NASDAQ: BLTE) priced an underwritten public offering of 2,272,727 ADSs at $154.00 per ADS, with gross proceeds expected to be approximately $350.0 million before underwriting discounts, commissions and expenses. The company granted underwriters a 30-day option to purchase up to 340,909 additional ADSs. Closing is expected on or about December 3, 2025, subject to customary closing conditions.
Belite said it intends to use net proceeds for commercialization preparation, pipeline development and working capital. Joint active book-runners include Morgan Stanley, Leerink Partners, BofA Securities and Cantor; H.C. Wainwright is lead manager.
Belite Bio (NASDAQ: BLTE) announced on December 1, 2025 that it has commenced an underwritten public offering of American Depositary Shares (ADSs), with all offered securities to be sold by the company.
The company said it will grant underwriters a 30-day option to buy additional ADSs and that the offering is subject to market conditions. Net proceeds are intended for commercialization preparation, pipeline development and working capital. Joint book-running managers include Morgan Stanley, Leerink Partners, BofA Securities and Cantor. The offering will be made only by a prospectus supplement to the company’s Form F-3ASR registration statement.
Belite Bio (NASDAQ: BLTE) reported positive topline results from the global Phase 3 DRAGON trial of Tinlarebant in adolescent Stargardt disease (Dec 1, 2025). The trial (n=104) met its primary endpoint, showing a 35.7% reduction in retinal lesion growth versus placebo (p=0.0033) with supportive post‑hoc analyses (p<0.0001). Key secondary endpoints and fellow‑eye analyses were also statistically significant. Tinlarebant (5 mg daily) reduced RBP4 ~80% and was generally well tolerated. The company plans to file an NDA in 1H 2026.
Belite Bio (NASDAQ: BLTE) reported Q3 2025 results and clinical progress on November 10, 2025. Key corporate and clinical highlights include completion of PHOENIX enrollment with 530 subjects, completion of the pivotal DRAGON trial (104 subjects) with final topline data expected in Q4 2025, and regulatory acceptances: China NMPA agreed to accept an NDA with priority review and the UK MHRA agreed to accept a Conditional Marketing Authorization application for Tinlarebant based on interim DRAGON results. The company closed a $15M registered direct offering and a $125M private placement with potential for up to $165M more upon full warrant exercise, and held $275.6M cash and equivalents as of September 30, 2025. Q3 net loss was $21.7M; year-to-date net loss was $52.3M.
Belite Bio (NASDAQ: BLTE) will host a live webcast on Monday, November 10, 2025 at 4:30 p.m. ET (1:30 p.m. PT) to discuss third quarter 2025 financial results and provide a business update for the period ended September 30, 2025.
Investors can join at https://events.q4inc.com/attendee/847711723 or via the company’s Investor Relations "Presentations & Events" page. A replay will be available for approximately 90 days after the event.
Belite Bio (NASDAQ: BLTE) said the UK Medicines and Healthcare Products Regulatory Agency agreed to accept a Conditional Marketing Authorization application for Tinlarebant to treat Stargardt disease based on the Phase 3 DRAGON interim analysis.
The pivotal DRAGON trial enrolled 104 subjects across 11 jurisdictions with 2:1 randomization; the primary endpoint is atrophic lesion growth rate. The company expects topline final data in Q4 2025, which it plans to submit to MHRA for a full Marketing Authorization application.
Belite Bio (NASDAQ: BLTE) announced that its executive management team will present at the Deutsche Bank ADR Virtual Investor Conference on November 4, 2025 at 10:30 AM ET. The presentation will be webcast and accessible via the conference site at www.adr.db.com/dbvic. A replay will be available for 90 days after the presentation.
The presentation covers corporate strategy and clinical-stage programs focused on degenerative retinal diseases; investors can access the live webcast and on-demand replay through the conference platform.
Belite Bio (NASDAQ: BLTE) announced that its executive management team will participate in the Maxim Growth Summit on October 22, 2025.
Belite is a clinical-stage company developing novel therapeutics for degenerative retinal diseases. Investors or partners seeking a one-on-one meeting are instructed to contact their Maxim representative to schedule.
Belite Bio (NASDAQ: BLTE) announced that China’s NMPA agreed to accept a New Drug Application with priority review for Tinlarebant to treat Stargardt disease based on interim results from the Phase 3 DRAGON trial.
The interim analysis showed statistical significance on the trial’s primary endpoint (growth rate of atrophic lesions). The global, randomized 2:1 DRAGON trial enrolled 104 subjects across 11 jurisdictions. Final topline data are expected in Q4 2025, and the NDA package is being prepared for submission to China CDE per guidance.
Belite Bio (NASDAQ: BLTE) has announced the completion of its pivotal Phase 3 DRAGON clinical trial evaluating Tinlarebant for treating Stargardt disease type 1 (STGD1). The trial enrolled 104 adolescent subjects across 11 jurisdictions, with 94 subjects completing the study.
Tinlarebant has received multiple regulatory designations, including Breakthrough Therapy, Fast Track, and Rare Pediatric Disease Designations in the U.S., Orphan Drug Designation in the U.S., Europe, and Japan, and Pioneer Drug Designation in Japan. The company expects to report topline results in Q4 2025 and plans to file New Drug Applications in 1H 2026.
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