Belite Bio, Inc - BLTE STOCK NEWS

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.

Belite Bio (NASDAQ: BLTE) announced the presentation of 1-year interim data from its 2-year Phase 1b/2 trial of LBS-008 for adolescent STGD1 at the American Academy of Ophthalmology Annual Meeting, scheduled for October 1, 2022, in Chicago. This novel oral therapy aims to prevent the accumulation of toxins in the eye associated with STGD1 and Dry AMD. LBS-008 has received multiple regulatory designations, including Fast Track and Orphan Drug in the U.S. and Europe, highlighting its potential as a treatment for currently untreatable eye diseases.

Belite Bio has received approval from China's National Medical Products Administration to initiate the Phase 3 clinical trial of LBS-008, an oral treatment for Stargardt disease (STGD1). The DRAGON trial, which is already underway globally, aims to evaluate the safety and efficacy of LBS-008 in adolescent STGD1 patients. Preliminary Phase 2 results show that 61.5% of participants gained visual acuity. LBS-008 has also been granted Fast Track and Orphan Drug Designations due to its potential to address significant unmet medical needs in retinal diseases.

Belite Bio has initiated a Phase 3 clinical trial for its lead asset, LBS-008 (Tinlarebant), targeting Stargardt Disease (STGD1), a degenerative eye condition with no current treatments. This randomized, double-masked, placebo-controlled study involves sites in multiple countries including the U.S. and U.K. LBS-008 has received fast track and orphan drug designations. Preliminary Phase 2 trial results show 61.5% of adolescent participants experienced visual acuity improvements, prompting optimism about its potential for STGD1 and Dry AMD treatment.

Belite Bio (NASDAQ: BLTE) reported significant advancements in its lead asset, LBS-008 (Tinlarebant), targeting Stargardt disease and Dry AMD. The ongoing Phase 3 trial (DRAGON) has commenced in multiple countries, enrolling several patients. LBS-008 has received fast track, rare pediatric disease, and orphan drug designations. Financially, as of June 30, 2022, Belite holds $48.7 million in cash, with a reduced net loss of $3.5 million compared to $4.7 million in the previous year.