Belite Bio, Inc, a clinical-stage biopharmaceutical drug development company, engages in the research and development of novel therapeutics targeting atrophic age-related macular degeneration and autosomal recessive stargardt diseases. Its lead product candidate is LBS-008, an oral once-a-day treatment that can reduce and maintain the delivery of vitamin A to the eye to reduce the accumulation of toxic vitamin A by-products in ocular tissue that is in phase 3 clinical trial. The company is also developing LBS-009, an anti-retinol binding protein 4 oral therapy targeting liver disease, including non-alcoholic fatty liver disease, nonalcoholic steatohepatitis, and type 2 diabetes, which is in the preclinical development phase. Belite Bio, Inc was founded in 2016 and is based in San Diego, California. Belite Bio, Inc operates as a subsidiary of Lin Bioscience International Ltd.
IPO Year: 2022
Exchange: NASDAQ
Website: https://belitebio.com
Date | Price Target | Rating | Analyst |
---|---|---|---|
12/14/2023 | $60.00 | Buy | Maxim Group |
7/28/2023 | $43.00 | Overweight | Cantor Fitzgerald |
7/26/2023 | $25.00 | Outperform | SVB Securities |
8/1/2022 | $58.00 | Buy | H.C. Wainwright |
Dr. Scholl is a globally recognized leader in the field of ophthalmology and the coordinating principal investigator of the largest ever natural history study of Stargardt disease SAN DIEGO, Sept. 01, 2024 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ:BLTE) ("Belite Bio" or the "Company"), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that its board of directors has appointed Hendrik P. N. Scholl, MD, MA, as the Chief Medical Officer of the Company, effective immediately. Dr. Scholl is the foremost globally recognized authority on Stargar
An independent Data Safety Monitoring Board (DSMB) for the Phase 3 DRAGON trial recommends trial continuation without any modifications, maintaining the sample size at 104 subjects following a planned interim efficacy analysis; trial completion expected by Q4 2025 (including a three-month follow-up period)Tinlarebant has been granted Fast Track and Rare Pediatric Disease Designations in the U.S., Orphan Drug Designation in the U.S., Europe, and Japan, and the Pioneer Drug Designation in Japan for Stargardt disease, for which there are no approved treatments SAN DIEGO, Feb. 27, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ:BLTE) ("Belite" or the "Company"), a clinical-stage biopharm
SAN DIEGO, Feb. 05, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc ("BLTE" or the "Company") (NASDAQ:BLTE), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that it has entered into a securities purchase agreement with a new, fundamental healthcare investor for the purchase and sale of 258,309 American Depositary Shares ("ADSs") and warrants to purchase 258,309 ADSs, at a purchase price of $58.07 per ADS and accompanying warrant, pursuant to a registered direct offering, equivalent to today's closing price. The offering is expected to result in gro
Fast Track designation indicates LBS-007's potential in filling the unmet medical need of acute leukemiaLBS-007 is the Company's investigational medicinal product for the treatment of acute leukemiaA Phase 1/2 trial in patients with relapsed or resistant acute leukemias is ongoingLBS-007, the Company's lead asset, has been granted orphan drug designations for acute myeloid leukemia and acute lymphocytic leukemia by the U.S. FDA TAIPEI CITY, Taiwan, Nov. 27, 2024 (GLOBE NEWSWIRE) -- Lin BioScience (6696. Taiwan OTC), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting acute leukemia that have significant unmet medical needs, today a
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,
SAN DIEGO, Nov. 05, 2024 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ:BLTE), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that it will host a webcast on Tuesday, November 12, 2024, at 4:30 p.m. Eastern Time to discuss the Company's financial results and provide a business update for the third quarter ended September 30, 2024. Webcast InformationDate: Tuesday, November 12, 2024 Time: 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time)Webcast Link: https://wsw.com/webcast/cc/blte5/1423080 Webcast Link InstructionsYou can join the live webcast
SAN DIEGO, Nov. 03, 2024 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ:BLTE) ("Belite Bio" or the "Company"), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announces the entry into a definitive agreement for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 651,380 ordinary shares of the Company originally issued in April 2024, at an exercise price of US$44.14 per share. The gross proceeds to the Company from the exercise of the warrants are expected to be approximately US$28.75 million. The Company intends to us
SAN DIEGO, Oct. 14, 2024 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ:BLTE) ("Belite" or the "Company"), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that the Company will present data from its completed Phase II adolescent Stargardt disease trial at the American Academy of Ophthalmology Annual Meeting (AAO 2024) being held October 18-21, 2024, in Chicago, IL. Podium Presentation: Title: Tinlarebant (LBS-008) for Adolescents with Stargardt DiseasePresentation Type: Late breaking developments (live broadcast)Presenting Author: Quan D
SAN DIEGO, Oct. 08, 2024 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ:BLTE), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that Hendrik P.N. Scholl, MD, MA, Chief Medical Officer of Belite Bio, will participate in the "Ocular Drug Development" panel discussion at the Maxim Group 2024 Healthcare Virtual Summit on Tuesday, October 15, 2024 at 11:00 am ET. The live panel discussion can be accessed on Maxim's M-Vest website. For more information and to sign up, please visit: https://m-vest.com/events/healthcare-10152024. About Belite Bio Bel
NEW YORK, Sept. 17, 2024 (GLOBE NEWSWIRE) -- Deutsche Bank today announced the lineup for its Depositary Receipts Virtual Investor Conference ("dbVIC") on Tuesday, September 24 and Wednesday, September 25, featuring live webcast presentations from international companies with American Depositary Receipt (ADR) programs in the US. Representatives from participating companies based in China, France, Hong Kong, Netherlands, Philippines, Portugal, Spain, Switzerland, and the United Kingdom will respond to questions during formal presentations. The conference is targeted to all categories of investors and analysts interested in international companies. There is no fee for participants to log i
Phase 2/3 of the DRAGON II trial will evaluate the efficacy, safety, and tolerability of Tinlarebant in approximately 60 adolescent STGD1 subjects across the U.S., U.K., and JapanPhase 1b of DRAGON II trial to evaluate pharmacokinetics and pharmacodynamics of Tinlarebant in Japanese subjects was recently completedTinlarebant granted Orphan Drug and Sakigake (Pioneer Drug) Designation in Japan for the treatment of STGD1Pivotal global Phase 3 trial of Tinlarebant in GA subjects ("PHOENIX") is ongoing and more than 200 subjects have been enrolled SAN DIEGO, Sept. 10, 2024 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ:BLTE) ("Belite" or the "Company"), a clinical-stage biopharmaceutical drug de
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Maxim Group initiated coverage of Belite Bio with a rating of Buy and set a new price target of $60.00
Cantor Fitzgerald initiated coverage of Belite Bio with a rating of Overweight and set a new price target of $43.00
SVB Securities initiated coverage of Belite Bio with a rating of Outperform and set a new price target of $25.00
H.C. Wainwright initiated coverage of Belite Bio with a rating of Buy and set a new price target of $58.00
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