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 (BLTE) is a clinical-stage biopharmaceutical company advancing novel therapies for retinal degenerative diseases and metabolic disorders through its proprietary anti-RBP4 platform. This page serves as the definitive source for verified company announcements, clinical development updates, and regulatory milestones.
Investors and researchers will find timely updates on BLTE's pipeline progress, including trial results for conditions like dry AMD and Stargardt disease, along with strategic partnership announcements. All content is curated to provide actionable insights into the company's scientific advancements and market positioning.
Key updates include phase trial developments, FDA designations, intellectual property milestones, and peer-reviewed research publications. Content is organized chronologically while maintaining clinical context to help users track therapeutic progress across ocular and metabolic treatment areas.
Bookmark this page for direct access to Belite Bio's official communications, presented with clarity for both professional investors and those monitoring advancements in vision preservation therapies. Check regularly for updates on groundbreaking approaches to retinal disease management and metabolic disorder treatment innovations.
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.
Belite Bio (NASDAQ: BLTE) has secured a significant private placement financing of up to $275 million from leading healthcare investors, led by RA Capital Management. The transaction includes $125 million upfront through the issuance of 1,953,124 ordinary shares and warrants at $64.00 per share, with potential for an additional $150 million through warrant exercises.
The warrants will be immediately exercisable at $76.80 per share (20% premium) and expire in two years. The financing, expected to close around September 9, 2025, includes participation from Eventide Asset Management, Marshall Wace, RTW Investments, Soleus Capital, and Vestal Point Capital. Proceeds will support commercialization preparation and general corporate purposes for tinlarebant, their treatment for Stargardt disease and geographic atrophy.
Belite Bio (NASDAQ: BLTE), a clinical-stage drug development company specializing in novel therapeutics for degenerative retinal diseases, has announced its participation in three major investor conferences in September 2025.
The company will present at the Cantor Global Healthcare Conference (September 5, 8:00 am ET), the Morgan Stanley 23rd Annual Global Healthcare Conference (September 8, 5:35 pm ET), and the H.C. Wainwright 27th Annual Global Investment Conference (September 9, 8:00 am ET). All presentations will be available via webcast on the company's investor relations website, with replays archived for 90 days.
Belite Bio (NASDAQ: BLTE) reported Q2 2025 financial results and provided significant updates on its clinical programs. The company achieved two major milestones: FDA Breakthrough Therapy Designation for Tinlarebant in treating Stargardt disease (STGD1) and completion of enrollment with 529 subjects in the Phase 3 PHOENIX trial for geographic atrophy (GA).
Financial highlights include a net loss of $16.3 million for Q2 2025, with $149.2 million in cash and equivalents. The company recently raised $15 million through a registered direct offering. R&D expenses increased to $11.0 million, up from $9.1 million in Q2 2024, while G&A expenses rose to $6.5 million from $1.4 million.
The DRAGON trial for STGD1 is expected to complete by Q4 2025, following positive DSMB recommendations for trial continuation.
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