Belite Bio, Inc Stock Price, News & Analysis

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.

Belite Bio, a biopharmaceutical company focused on untreatable eye diseases, will host a conference call on August 11, 2022, at 4:30 PM ET to discuss financial results for the first half of 2022.

The results will be released on August 10, 2022. Investors can join the call through a webcast or phone registration. The company is developing treatments for conditions like dry AMD and Stargardt disease.

Belite Bio (NASDAQ: BLTE) has submitted an IND application to the FDA for LBS-008, an oral treatment for Stargardt disease (STGD1), currently with no FDA-approved therapies. This drug, a retinol binding protein 4 antagonist, aims to reduce toxic vitamin A byproducts implicated in vision loss. Two ongoing trials, including a Phase 2 and a global Phase 3 (DRAGON), have shown promising initial results, with 61.5% of Phase 2 participants gaining visual acuity. The company has received fast track, rare pediatric disease, and orphan drug designations for LBS-008.

Belite Bio, a clinical stage biopharmaceutical company focused on treating eye diseases, announced that the underwriters for its IPO exercised part of their over-allotment option. This resulted in the sale of an additional 772,091 American Depositary Shares (ADS) at $6.00 each, raising total gross proceeds to approximately $40.63 million. The funds will support the Phase 3 trial of LBS-008 for Stargardt disease and further development for dry AMD, alongside working capital needs. The SEC had declared the registration statement effective earlier in April 2022.

Belite Bio (Nasdaq: BLTE) announced interim results from its Phase 1b/2 study of LBS-008 for adolescent Stargardt disease (STGD1) at the ARVO 2022 meeting. The treatment displayed an acceptable safety profile, with mild adverse events, and a majority of participants showing stabilized or improved visual acuity. LBS-008 effectively reduced RBP4 levels by 80-90%. The study's extension phase will involve ongoing evaluation over two years, highlighting its potential for treating currently untreatable eye diseases.

Belite Bio (BLTE) has successfully closed its initial public offering, selling 6 million American Depositary Shares (ADSs) at $6.00 each, accumulating gross proceeds of $36 million. An additional 900,000 ADSs may be purchased by underwriters. Principal shareholder Lin Bioscience invested $15 million in the offering. The ADSs are now listed on the Nasdaq Capital Market, trading under BLTE since April 29, 2022. The funds will support the Phase 3 clinical trial of LBS-008 for Stargardt disease, further development for dry AMD, and general corporate purposes.

Belite Bio (Nasdaq: BLTE) announced that LBS-008, an oral tablet for treating Stargardt disease (STGD1), has received Fast Track Designation from the FDA. This designation accelerates the development of drugs for serious conditions lacking approved treatments. The company is currently conducting a Phase 2 and a Phase 3 trial for STGD1, which affects around 30,000 patients in the U.S. This follows LBS-008's recognition as a rare pediatric disease and orphan drug in both the U.S. and Europe. The next data readout for the Phase 2 trial is anticipated in Q4 2022.