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) 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.
Belite Bio (NASDAQ:BLTE), a clinical-stage drug development company focused on degenerative retinal diseases, has announced a $15 million registered direct offering to a single large existing institutional shareholder. The offering consists of 230,770 American Depositary Shares (ADSs) and warrants at $65 per ADS and accompanying warrant.
The transaction includes five-year warrants that could generate an additional $15 million in proceeds if exercised. The offering is expected to close around August 8, 2025, with Titan Partners Group acting as the sole placement agent. The company plans to use the proceeds for working capital and general corporate purposes.
Belite Bio (NASDAQ: BLTE), a clinical-stage drug development company specializing in novel therapeutics for degenerative retinal diseases, will participate in the H.C. Wainwright Annual Ophthalmology Virtual Conference on August 13, 2025.
The company's executive management team will deliver two presentations: an on-demand corporate presentation at 7:00 AM ET and participate in a panel discussion on "Pivotal-Stage Assets for Retinal Disorders" at 11:00 AM ET. Both presentations will be accessible via webcast through Belite Bio's investor relations website, with replays available for 90 days.
Belite Bio (NASDAQ: BLTE), a clinical-stage drug development company specializing in novel therapeutics for degenerative retinal diseases, has scheduled a webcast for Monday, August 11, 2025, at 4:30 p.m. Eastern Time. During this event, the company will discuss its Q2 2025 financial results and provide a business update for the quarter ended June 30, 2025.
The webcast will be accessible through the company's investor relations website, and a replay will remain available for approximately 90 days following the event.
Belite Bio (NASDAQ: BLTE), a clinical-stage biopharmaceutical company developing treatments for degenerative retinal diseases, announced its participation in the upcoming BTIG Virtual Biotechnology Conference scheduled for July 29-30, 2025.
The company's executive management team will be available for one-on-one meetings with investors during the conference, which can be arranged through BTIG representatives.
Belite Bio (NASDAQ: BLTE) has announced the completion of enrollment in its pivotal global Phase 3 PHOENIX trial evaluating Tinlarebant for geographic atrophy (GA) in dry age-related macular degeneration (AMD). The trial has successfully enrolled 500 subjects across multiple countries including the United States, United Kingdom, France, Czech Republic, Switzerland, China, Taiwan, and Australia.
The 24-month, randomized, double-masked, placebo-controlled, multicenter study aims to evaluate the safety and tolerability of Tinlarebant and its potential to reduce atrophic lesion growth rate in GA patients. The United States led enrollment numbers, highlighting strong interest in the oral treatment option compared to existing invasive alternatives.
This milestone is particularly significant as there are currently no approved oral treatments for GA, which is an advanced stage of dry AMD causing progressive vision loss through expanding lesions in the retina. The company plans to share interim results at the trial's midpoint.
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