BLTE - Earnings announcements

Tinlarebant is the first therapeutic candidate to demonstrate clinical efficacy in a global Phase 3 trial for Stargardt disease, achieving a statistically significant p-value of 0.0033Tinlarebant met the primary efficacy endpoint, demonstrating clinical benefit by significantly reducing the lesion growth rate by 36% compared to placebo, as measured by retinal imagingTinlarebant was well tolerated throughout the trial Stargardt disease impacts more than 50,000 patients in the U.S. Belite Bio plans to file an NDA with the US FDA in 1H 2026Company will host a conference call and webcast today at 8:00 a.m. ET SAN DIEGO, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ:BLTE) ("Belite

Dosed first patient in Phase 2/3 DRAGON II trial of Tinlarebant for the treatment of Stargardt disease (STGD1)Pivotal global Phase 3 PHOENIX trial of Tinlarebant in geographic atrophy (GA) subjects is ongoing with more than 280 subjects enrolledAppointed Hendrik P.N. Scholl, MD, MA, a globally recognized leader in the field of ophthalmology and the coordinating principal investigator of the largest natural history study of Stargardt disease, as Chief Medical OfficerInterim analysis from the pivotal global Phase 3 DRAGON trial of Tinlarebant in adolescent STGD1 subjects anticipated by end of 2024 or early 2025Company to host webcast on Tuesday, November 12, 2024, at 4:30 p.m. EST SAN DIEGO,

Completed enrollment in pivotal Phase 3 "DRAGON" trial for Tinlarebant in adolescent Stargardt disease ("STGD1") with 104 subjects enrolled across 11 countries worldwideFirst subject dosed with Tinlarebant in pivotal global Phase 3 "PHOENIX" trial in Geographic Atrophy ("GA")Oral, once-daily Tinlarebant continues to be safe and well tolerated, slowing expansion of autofluorescence, reducing incident atrophic retinal lesion growth rate, and stabilizing visual acuity up to 24-months in Phase 2 STGD1 trial ("LBS-008-CT02")Interim Phase 3 safety and efficacy data from pivotal "DRAGON" trial expected in 2H 2024Conference Call and Webcast Tuesday, November 14, 2023, at 4:30 p.m. ET

In 18-month interim data from ongoing 2-year, Phase 2 Stargardt disease ("STGD1") trial ("LBS-008-CT02"), we continued to observe that oral Tinlarebant is safe and well tolerated in adolescent STGD1 subjectsA continued trend of slowing expansion of autofluorescence was observed and the growth rate of incident atrophic retinal lesions was reduced with Tinlarebant in LBS-008-CT02 compared to a natural history study of the disease ("ProgStar")Stabilization of visual acuity with no significant loss and no clinically significant changes in retinal thickness observed over 18 months of treatment with Tinlarebant in LBS-008-CT0258 subjects have been enrolled in the pivotal Phase 3 "DRAGON" trial eva

SAN DIEGO, Aug. 01, 2022 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ:BLTE), a San Diego based clinical stage biopharmaceutical drug development company targeting untreatable eye diseases, will host a conference call on Thursday, August 11, 2022, at 4:30 p.m. Eastern time to discuss the Company's financial results for the first half, ended June 30, 2022, and provide a corporate progress update. The financial results will be issued in a press release on Wednesday, August 10, 2022. Belite Bio, Inc First Half 2022 Financial Result Conference Call Information: Date:Thursday, August 11, 2022Time:4:30 p.m. Eastern time (1:30 p.m. Pacific time)Webcast Link:https://edge.media-server.com/mmc/p/d