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 (NASDAQ: BLTE) is a clinical-stage drug development company focused on novel oral therapeutics for degenerative retinal diseases with significant unmet medical needs, including Stargardt disease type 1 (STGD1) and geographic atrophy (GA) in advanced dry age-related macular degeneration (AMD). The BLTE news feed highlights how the company advances its lead candidate, Tinlarebant, through late-stage clinical trials and global regulatory pathways.
Investors and observers following Belite Bio’s news can track updates on pivotal clinical programs such as the Phase 3 DRAGON and DRAGON II trials in adolescent STGD1 patients and the Phase 3 PHOENIX trial in GA. Company announcements cover milestones like completion of trial enrollment, last subject visits, and the release of topline efficacy and safety data, including the reported positive Phase 3 DRAGON results showing reduced lesion growth in STGD1.
The BLTE news stream also features information on regulatory interactions and designations for Tinlarebant, including Breakthrough Therapy, Fast Track, Rare Pediatric Disease, Orphan Drug, and Sakigake (Pioneer Drug) designations, as well as decisions by agencies such as China’s NMPA and the UK’s MHRA to accept applications based on interim Phase 3 data. In addition, readers can follow Belite Bio’s capital markets activities, including registered direct offerings, private placements, and underwritten public offerings of American Depositary Shares that the company describes as supporting clinical development and commercialization preparation.
By reviewing Belite Bio news, users can see how clinical data, regulatory developments, and financing events shape the company’s efforts to develop Tinlarebant as a potential oral treatment option for inherited and degenerative retinal diseases.
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.
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.