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.
Belite Bio, Inc. reports clinical and regulatory developments for tinlarebant, an oral investigational therapy for degenerative retinal diseases. The company focuses on Stargardt disease type 1 (STGD1) and geographic atrophy in advanced dry age-related macular degeneration, with a program designed to reduce accumulation of bisretinoid toxins in the eye.
Recurring updates include DRAGON and DRAGON II Stargardt disease studies, PHOENIX geographic atrophy development, FDA interactions, scientific meeting presentations, investor-conference appearances, financial results, annual Form 20-F availability, and capital actions involving American Depositary Shares. Company news also covers corporate updates for a foreign private issuer whose securities trade under BLTE.
Belite Bio (NASDAQ: BLTE) will host a live webcast on March 2, 2026 at 4:30 p.m. ET to discuss preliminary, unaudited fourth quarter and full year 2025 financial results and provide a business update.
According to the company, the webcast link is available at the events page and a replay will be accessible for approximately 90 days after the event.
Belite Bio (NASDAQ: BLTE) will participate at the 41st APAO Congress in Hong Kong, Feb 5-7, 2026, featuring oral presentations, a sponsored lunch symposium, and an exhibition booth.
Presentations include previously disclosed topline results from the Phase 3 DRAGON study of tinlarebant in adolescents with Stargardt disease type 1 and individual patient case reports.
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.
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.