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) announced two upcoming poster presentations at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Salt Lake City, Utah, from May 4-8, 2025.
The presentations will focus on the company's ongoing clinical trials for Stargardt disease:
- The first poster will present baseline characteristics from the Phase 3 DRAGON trial of Tinlarebant in adolescent patients, presented by Dr. Ruifang Sui
- The second poster will discuss pharmacokinetic and pharmacodynamic properties from the DRAGON II trial in Japanese adolescent patients, presented by Dr. Kaoru Fujinami
Both presentations are scheduled for Monday, May 5, from 8:30-10:15 a.m. MDT in Session 215: Retinitis Pigmentosa and IRD I.
Belite Bio (NASDAQ: BLTE) has reported its Q4 and full-year 2024 financial results. The company's Phase 3 DRAGON trial for Stargardt 1 (STGD1) treatment received DSMB recommendation to proceed without modifications, with completion expected in Q4 2025. The PHOENIX trial for geographic atrophy has enrolled 406 subjects.
Key financial highlights: Cash position of $31.7 million as of December 31, 2024, with additional $113.5 million in investments. The company raised $15 million through a registered direct offering in February 2025. Full-year 2024 results showed R&D expenses of $29.9 million (up from $24.8M in 2023) and G&A expenses of $10.1 million (up from $6.8M in 2023). Net loss for 2024 was $36.1 million or ($1.18) per share.
Tinlarebant, their lead drug candidate, is advancing in multiple trials including the DRAGON trial for STGD1 and PHOENIX trial for geographic atrophy. The drug has received Fast Track, Rare Pediatric Disease, and Orphan Drug Designations in various regions.
Belite Bio (NASDAQ: BLTE), a San Diego-based clinical stage biopharmaceutical company, has announced the availability of its annual report on Form 20-F for the fiscal year ended December 31, 2024. The report, which includes audited consolidated financial statements, was filed with the Securities and Exchange Commission on March 17, 2025, and can be accessed through the company's website at belitebio.com. Shareholders can request a free hard copy of the annual report.
Belite Bio (NASDAQ: BLTE), a clinical-stage biopharmaceutical company focused on developing treatments for degenerative retinal diseases, has scheduled a webcast for March 17, 2025, at 4:30 p.m. Eastern Time. The event will present the company's fourth quarter and full year 2024 financial results, along with a business update.
The webcast will be accessible through the company's investor relations website and will remain available for replay for approximately 90 days following the presentation.
Belite Bio (NASDAQ: BLTE), a clinical-stage biopharmaceutical company developing treatments for degenerative retinal diseases, has announced its participation in the upcoming Leerink Partners Global Healthcare Conference.
The event will take place in Miami, FL from March 10-12, 2025. The company's executive management team will host a fireside chat on Monday, March 10, 2025, at 3:00 pm ET.
Investors and interested parties can access the webcast through the 'Events' section on Belite Bio's investor relations website. The presentation recording will remain available for 90 days after the event.
Belite Bio (NASDAQ: BLTE) announced interim analysis results from its pivotal Phase 3 DRAGON trial of Tinlarebant in adolescent Stargardt disease patients. The Data Safety Monitoring Board (DSMB) recommended trial continuation without modifications, maintaining the original 104-subject sample size. The trial is expected to complete by Q4 2025.
Key findings show that Tinlarebant is well-tolerated with a consistent safety profile. Visual acuity remained stable in most subjects, with mean changes from baseline of less than three letter scores under both standard and low luminance throughout the two-year study.
The DRAGON trial is a randomized, double-masked, placebo-controlled study across 11 jurisdictions, with 2:1 randomization (active:placebo). The primary endpoint measures atrophic lesion growth rate. Tinlarebant has received multiple regulatory designations, including Fast Track and Rare Pediatric Disease in the U.S., Orphan Drug status in the U.S., Europe, and Japan, and Pioneer Drug Designation in Japan for Stargardt disease, which currently has no approved treatments.
Belite Bio (BLTE) has announced a registered direct offering expected to raise $15 million through the sale of 258,309 American Depositary Shares (ADSs) and warrants. The offering price is set at $58.07 per ADS and accompanying warrant, matching the day's closing price. The five-year warrants could potentially generate an additional $15 million if exercised.
The offering, conducted under a shelf registration statement, is expected to close around February 7, 2025. Titan Partners Group, a division of American Capital Partners, serves as the sole placement agent. The company plans to use the proceeds for working capital and general corporate purposes.
Belite Bio (NASDAQ: BLTE) reported Q3 2024 financial results and clinical progress. The company has dosed the first patient in Phase 2/3 DRAGON II trial for Stargardt disease treatment and enrolled over 280 subjects in the Phase 3 PHOENIX trial for geographic atrophy. Cash position stands at $109.0 million, with Q3 net loss of $8.7 million. R&D expenses decreased to $6.8 million from $8.7 million year-over-year. The company appointed Dr. Hendrik Scholl as CMO and received $28.75 million from warrant exercises. An interim analysis from the Phase 3 DRAGON trial is expected by end of 2024 or early 2025.
Belite Bio (NASDAQ: BLTE) announced it will host a webcast on November 12, 2024 at 4:30 p.m. Eastern Time to discuss its third quarter 2024 financial results and provide a business update. The clinical-stage biopharmaceutical company, which focuses on developing novel therapeutics for degenerative retinal diseases, will make the webcast available through their website. A replay will be accessible for approximately 90 days following the event.
Belite Bio (NASDAQ: BLTE) has secured US$28.75 million through the exercise of warrants at US$44.14 per share for 651,380 ordinary shares. In exchange for this immediate cash exercise, the company will issue new unregistered warrants for the same number of shares with an exercise price of US$70.00 per share, valid for five years. If these new warrants are fully exercised, they could generate additional gross proceeds of approximately US$45.6 million. The company plans to use the proceeds for general corporate purposes.
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