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.
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Belite Bio (NASDAQ: BLTE) presented 18-month interim data from its Phase 2 study of Tinlarebant for adolescent Stargardt Disease (STGD1) at the ARVO Annual Meeting. The study shows that Tinlarebant is safe and well-tolerated, with 60% of the 12 subjects demonstrating no incident atrophic retinal lesions. The growth of retinal lesions was significantly reduced compared to a historical study. Visual acuity remained stable, and no significant retinal thickness changes were observed. The company is enrolling patients for a Phase 3 study (DRAGON) targeting STGD1 and plans to initiate another Phase 3 study for Geographic Atrophy (GA) in mid-2023. The next readout is anticipated in Q4 2023.
Belite Bio, a clinical stage biopharmaceutical company focused on eye diseases, will host a virtual event on May 3, 2023, at 1:00 PM ET. The event features key opinion leader Hendrik Scholl, M.D. from the University of Basel, who will present 18-month interim efficacy and safety data from the Phase 2 trial of tinlarebant for treating Stargardt disease (STGD1). This once-a-day oral medication is designed to inhibit RBP4 and reduce toxic vitamin A accumulation linked to STGD1 progression. Tinlarebant has received Fast Track and Orphan Drug designations in the U.S., and orphan designation in Europe. Following the presentations, a live Q&A session will be held. Interested participants can join through the webcast link, with a replay available for 90 days after the event.
Belite Bio (NASDAQ: BLTE) reported key developments in their ongoing clinical trials for Stargardt disease (STGD1) and Geographic Atrophy (GA). Interim data shows tinlarebant may slow lesion growth in STGD1 with an 18-month update expected at the ARVO meeting on April 25. The pivotal DRAGON trial has enrolled 42 of the targeted 90 subjects. Additionally, the first patient for the PHOENIX trial is anticipated mid-2023. Financially, Belite closed 2022 with $42.1 million in cash but reported a net loss of $12.6 million, increasing from $9.7 million in 2021. The company plans to use IPO proceeds to advance its Phase 3 trials and general corporate purposes.
Belite Bio, Inc (NASDAQ: BLTE), a clinical-stage biopharmaceutical company, will host a live webcast on April 3, 2023, at 4:30 p.m. Eastern time to discuss its 2022 financial results and provide a business update. The financial results will be released on March 31, 2023. The company's focus is on developing treatments for eye diseases with significant unmet needs, such as advanced age-related macular degeneration and Stargardt disease. Interested parties can join the webcast through the provided link, and a replay will be accessible for 90 days post-event.
Belite Bio (NASDAQ: BLTE) has made significant advancements with its oral therapy, Tinlarebant (LBS-008), aimed at treating Stargardt Disease (STGD1) and Dry Age-related Macular Degeneration (Dry AMD). Currently, there are no approved treatments for these diseases. The company is conducting a Phase 2 study, showing promise in slowing lesion growth, while preparing to launch a global Phase 3 study for geographic atrophy associated with Dry AMD. Tinlarebant has received Fast Track and Orphan Drug designations, emphasizing its potential in the market.
Belite Bio, Inc (NASDAQ: BLTE) is set to host a KOL event on October 27, 2022, focusing on LBS-008 (Tinlarebant), its lead oral treatment for Stargardt Disease and Dry AMD. Dr. Quan Dong Nguyen from Stanford will present one-year interim data from a Phase 1b/2 trial. Tinlarebant, aimed at reducing toxic retinal byproducts, has received Fast Track and Orphan Drug Designations. With over 11 million Dry AMD patients in the U.S. and significant global healthcare costs, advancements in treatments like LBS-008 are crucial for eye health.
Belite Bio (NASDAQ: BLTE) announced promising 12-month results from its Phase 2 study of LBS-008 (Tinlarebant) in adolescents with Stargardt Disease (STGD1). The data revealed safety and tolerability, with 92.3% of subjects showing no atrophic lesions. A significant percentage reported stabilization in visual acuity and retinal thickness. Notably, the average lesion growth rate was only 0.03 mm2/year, indicating potential to slow disease progression compared to historical data. The next data readout is anticipated in Q2 2023.