Completed enrollment with 530 subjects in the pivotal phase 3 PHOENIX trial in geographic atrophy (GA) Completed $15 million registered direct offering and $125 million private placement with potential for up to an additional $165 million upon full warrant exercise Completed pivotal phase 3 DRAGON trial in Stargardt disease (STGD); final topline data expected in Q4 2025 China’s NMPA has agreed to accept New Drug Application... Read More

SAN DIEGO, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Belite Bio , Inc (NASDAQ: BLTE), a clinical-stage 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 Monday, November 10, 2025, at 4:30 p.m. Eastern Time to discuss the Company’s financial results and provide a business update for the... Read More

MHRA response is based on the Phase 3 DRAGON interim analysis results Topline final data expected in Q4 2025 SAN DIEGO, Nov. 02, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that United Kingdom’s Medicines and Healthcare Products... Read More

SAN DIEGO, Oct. 16, 2025 (GLOBE NEWSWIRE) -- Belite Bio Inc (NASDAQ: BLTE) (“Belite” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that the executive management team will be participating in the Maxim Growth Summit on October 22, 2025. To schedule a one-on-one meeting with... Read More

NMPA’s response is based on the Phase 3 DRAGON interim analysis results Topline final data expected in Q4 2025 SAN DIEGO, Oct. 15, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that the Center for Drug Evaluation of China’s National... Read More

Tinlarebant has been granted Breakthrough Therapy, Fast Track, and Rare Pediatric Disease Designations in the U.S.; Orphan Drug Designation in the U.S., Europe, and Japan; and Pioneer Drug Designation in Japan for Stargardt disease Last subject visit completed in the pivotal Phase 3 DRAGON trial of Tinlarebant in Stargardt disease Topline data expected in Q4 2025 SAN DIEGO, Sept. 12, 2025 (GLOBE NEWSWIRE) -- Belite Bio Inc... Read More

Transaction led by RA Capital Management with participation from Eventide Asset Management, Marshall Wace, RTW Investments, Soleus Capital and Vestal Point Capital $125 million financing upfront with up to an additional $150 million tied to exercise of warrants Warrants exercisable at a 20% premium to purchase price SAN DIEGO, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc ("Belite Bio" or the "Company") (Nasdaq: BLTE),... Read More

SAN DIEGO, Aug. 27, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that the executive management team will participate in three upcoming investor conferences. Details of the presentations are as follows: Cantor Global Healthcare... Read More

Tinlarebant granted Breakthrough Therapy Designation for Stargardt disease (STGD1) by the U.S. Food and Drug Administration (FDA) DRAGON trial completion expected by Q4 2025 (including a three-month follow-up period) Enrollment completed with 529 subjects in the pivotal phase 3 PHOENIX trial in geographic atrophy (GA) Raised approximately $15 million in gross proceeds in a registered direct offering on August 8, 2025... Read More

The offering was to a single large existing institutional shareholder SAN DIEGO, Aug. 07, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc ("BLTE" or the "Company") (Nasdaq: BLTE), a clinical-stage 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 for the purchase... Read More

SAN DIEGO, Aug. 06, 2025 (GLOBE NEWSWIRE) -- Belite Bio , Inc (NASDAQ: BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that the executive management team will participate in a panel discussion and corporate presentation at the H.C. Wainwright Annual Ophthalmology Virtual Conference on... Read More

SAN DIEGO, Aug. 04, 2025 (GLOBE NEWSWIRE) -- Belite Bio , Inc (NASDAQ: BLTE), a clinical-stage 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 Monday, August 11, 2025, at 4:30 p.m. Eastern Time to discuss the Company’s financial results and provide a business update for the second... Read More

SAN DIEGO, July 23, 2025 (GLOBE NEWSWIRE) -- Belite Bio , Inc (NASDAQ: BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that the executive management team will be participating in the BTIG Virtual Biotechnology Conference being held July 29-30, 2025. To schedule a one-on-one meeting with... Read More

500 subjects enrolled across the United States, the United Kingdom, France, Czech Republic, Switzerland, China, Taiwan, and Australia SAN DIEGO, July 02, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced the completion of enrollment in the... Read More

Designation is based on the pivotal Phase 3 DRAGON trial interim analysis results demonstrating Tinlarebant’s efficacy and favorable safety profile Trial completion expected by Q4 2025 (including a three-month follow-up period) Tinlarebant has previously 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... Read More

Following a pre-specified interim analysis, an independent Data Safety Monitoring Board (DSMB) recommended the pivotal Phase 3 trial (DRAGON) of Tinlarebant in adolescent Stargardt disease (STGD1) patients proceed without any modification; trial completion expected Q4 2025 (including a three-month follow-up period) DSMB also recommended the Company submit the interim data for further regulatory review for drug approval A... Read More

SAN DIEGO, May 12, 2025 (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 the executive management team will participate in four upcoming investor conferences. Details of the presentations are as follows: Deutsche Bank... Read More

SAN DIEGO, May 07, 2025 (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 Wednesday, May 14, 2025, at 4:30 p.m. Eastern Time to discuss the Company’s financial results and provide a business... Read More

SAN DIEGO, April 29, 2025 (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 the Company will give two poster presentations at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting being held May... Read More

SAN DIEGO, March 17, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE), a San Diego based clinical stage biopharmaceutical drug development company, today announced that its annual report on Form 20-F, containing audited consolidated financial statements for the year ended December 31, 2024, as filed with the Securities and Exchange Commission on March 17, 2025, is available through its website (... Read More

Following a pre-specified interim analysis, the Data Safety Monitoring Board (DSMB) recommended the DRAGON trial, a pivotal Phase 3 trial in adolescent Stargardt 1 (STGD1) subjects, proceed without any modification; trial completion expected Q4 2025 (including a three-month follow-up period) Pivotal global Phase 3 PHOENIX trial of Tinlarebant in geographic atrophy (GA) subjects is ongoing with 406 subjects enrolled Raised... Read More

SAN DIEGO, March 11, 2025 (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 Monday, March 17, 2025, at 4:30 p.m. Eastern Time to discuss the Company’s financial results and provide a business... Read More

SAN DIEGO, March 04, 2025 (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 the executive management team will participate in the Leerink Partners Global Healthcare Conference being held on March 10-12, 2025, in Miami,... Read More

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... Read More

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... Read More

Fast Track designation indicates LBS-007’s potential in filling the unmet medical need of acute leukemia LBS-007 is the Company’s investigational medicinal product for the treatment of acute leukemia A Phase 1/2 trial in patients with relapsed or resistant acute leukemias is ongoing LBS-007, the Company’s lead asset, has been granted orphan drug designations for acute myeloid leukemia and acute lymphocytic leukemia by the... Read More

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 enrolled Appointed 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... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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 Japan Phase 1b of DRAGON II trial to evaluate pharmacokinetics and pharmacodynamics of Tinlarebant in Japanese subjects was recently completed Tinlarebant granted Orphan Drug and Sakigake (Pioneer Drug) Designation in Japan for the treatment of STGD1... Read More

SAN DIEGO, Sept. 03, 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 the executive management team will participate in three upcoming investor conferences. Details for the presentations are as follows: H.C.... Read More

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... Read More

Tinlarebant, a novel oral therapy, is intended to slow disease progression in patients affected with Stargardt Disease (STGD1) and Geographic Atrophy (GA) in advanced Dry Age-related Macular Degeneration (Dry AMD) Phase 1b & 2/3 (“DRAGON II”) trial of Tinlarebant in adolescent STGD1 patients has been initiated and have completed enrollment for Phase 1b with six subjects in Japan Tinlarebant granted Orphan Drug and Sakigake... Read More

SAN DIEGO, Aug. 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 Dr. Nathan Mata, Chief Scientific Officer of Belite Bio, will present a corporate update at the H.C. Wainwright 4 th Annual Ophthalmology Virtual... Read More

SAN DIEGO, Aug. 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 Monday, August 12, 2024, at 4:30 p.m. Eastern Time to discuss the Company’s financial results and provide a business... Read More

SAN DIEGO, July 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 Dr. Nathan Mata, Chief Scientific Officer of Belite Bio, will participate in the JonesHealthcare Seaside Summit in Encinitas, CA, and present a... Read More

Tinlarebant is Belite Bio’s orally administered tablet intended to slow disease progression in patients affected with Stargardt Disease (STGD1) and Geographic Atrophy (GA) in advanced Dry Age-related Macular Degeneration (Dry AMD) Data from a 24-month Phase 2 trial in adolescent STGD1 subjects showed a sustained lower atrophic lesion growth in Tinlarebant-treated subjects compared to ProgStar participants possessing similar... Read More

SAN DIEGO, May 14, 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 the executive management team will participate in the Benchmark’s 4 th Annual Healthcare House Call Investor Conference being held virtually on May... Read More

Tinlarebant is Belite Bio’s orally administered tablet intended to slow disease progression in patients affected with Stargardt Disease (STGD1) and Geographic Atrophy (GA) in advanced Dry Age-related Macular Degeneration (Dry AMD) Data from a 24-month Phase 2 trial in adolescent STGD1 subjects showed a sustained lower atrophic lesion growth in Tinlarebant-treated subjects compared to ProgStar participants possessing similar... Read More

SAN DIEGO, May 13, 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 the executive management team will participate in the H.C. Wainwright 2nd Annual BioConnect Investor Conference being held in New York, NY, on May... Read More

SAN DIEGO, May 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 it will host a webcast on Tuesday, May 14, 2024, at 4:30 p.m. Eastern Time to discuss the Company’s financial results and provide a business update... Read More

Webinar, moderated by Cantor Fitzgerald, will be held on Monday, May 13, 2024, at 2:00 p.m. ET Discussion will feature Dr. Michel Michaelides, leading expert in the field of inherited eye disease in adults and children SAN DIEGO, May 06, 2024 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal... Read More

Additional analysis of visual acuity loss, genotypic profiles, and retinal imaging data from a 24-month Phase 2 trial of Tinlarebant in adolescent Stargardt disease patients provides further support for the potential of Tinlarebant to slow and potentially halt lesion growth In 5 of 12 subjects (42%) with known pathogenic ABCA 4 mutations, no incident atrophic (DDAF) lesions were formed during the 24-month treatment period... Read More

Tinlarebant is Belite Bio’s orally administered tablet intended to slow disease progression in patients affected with Stargardt Disease (STGD1) and Geographic Atrophy (GA) in advanced Dry Age-related Macular Degeneration (Dry AMD) Data from a 24-month Phase 2 trial in adolescent STGD1 subjects showed a sustained lower atrophic lesion growth in Tinlarebant-treated subjects compared to ProgStar participants possessing similar... Read More

SAN DIEGO, April 25, 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 it has entered into a securities purchase agreement with an institutional investor, for the purchase and sale of... Read More

Tinlarebant is Belite Bio’s orally administered tablet intended to slow disease progression in patients affected with Stargardt Disease (STGD1) and Geographic Atrophy (GA) in advanced Dry Age-related Macular Degeneration (Dry AMD) Data from a 24-month Phase 2 trial in adolescent STGD1 subjects showed a sustained lower atrophic lesion growth in Tinlarebant-treated subjects compared to ProgStar participants possessing similar... Read More

SAN DIEGO, March 11, 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 its annual report on Form 20-F, containing audited consolidated financial statements for the year ended December 31, 2023, as filed with the... Read More

Tinlarebant is Belite Bio’s orally administered tablet intended to slow disease progression in patients affected with Stargardt Disease (STGD1) and Geographic Atrophy (GA) in advanced Dry Age-related Macular Degeneration (Dry AMD) Data from a 24-month Phase 2 trial in adolescent STGD1 subjects showed a sustained lower atrophic lesion growth in Tinlarebant-treated subjects compared to ProgStar participants possessing similar... Read More

SAN DIEGO, March 06, 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, March 12, 2024, at 4:30 p.m. Eastern Time to discuss the Company’s financial results and provide a business... Read More

SAN DIEGO, March 04, 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 the executive management team will participate in the Leerink Partners Global Biopharma Conference being held in Miami, FL, on March 11-13, 2024.... Read More

SAN DIEGO, Feb. 07, 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 the executive management team will participate at the upcoming Oppenheimer 34 th Annual Healthcare Life Sciences Conference on February 13-14 and... Read More

SAN DIEGO, Nov. 30, 2023 (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 be participating at the Benchmark Company’s 12 th Annual Discovery One-on-One Investor Conference to be held Thursday, December 7, 2023, at... Read More

SAN DIEGO, Nov. 20, 2023 (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 management will participate in a fireside chat at the BTIG Ophthalmology Day on Monday, November 27, 2023, at 3:00 p.m. ET. The Belite management... Read More

Completed enrollment in pivotal Phase 3 “DRAGON” trial for Tinlarebant in adolescent Stargardt disease (“STGD1”) with 104 subjects enrolled across 11 countries worldwide First subject dosed with Tinlarebant in pivotal global Phase 3 “PHOENIX” trial in Geographic Atrophy (“GA”) Oral, once-daily Tinlarebant continues to be safe... Read More

SAN DIEGO, Nov. 07, 2023 (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 14, 2023, at 4:30 p.m. Eastern Time to discuss the Company’s financial results for the third quarter... Read More

Tinlarebant (a/k/a LBS-008) is Belite Bio’s orally administered tablet intended to slow disease progression in patients affected with Stargardt Disease (STGD1) and Geographic Atrophy (GA) in advanced Dry Age-related Macular Degeneration (Dry AMD) Tinlarebant was safe and well-tolerated in all subjects throughout the 24-month... Read More

Two-year data from the two-year Phase 1b/2 trial of Tinlarebant (LBS-008) in adolescent Stargardt Disease (STGD1) to be presented A two-year global Phase 3 trial in adolescent STGD1 (the “DRAGON” study) and a two-year global Phase 3 trial in Geographic Atrophy (GA) patients (the “PHOENIX” study) are on-going Tinlarebant has been granted Fast Track and Rare Pediatric Disease Designations in the U.S. and Orphan Drug... Read More

Completed enrollment in pivotal Phase 3 “DRAGON” trial for Tinlarebant in adolescent Stargardt disease (“STGD1”) with 100 subjects enrolled across 11 countries worldwide First subject dosed with Tinlarebant in pivotal global Phase 3 “PHOENIX” trial in Geographic Atrophy (“GA”) Oral, once-daily Tinlarebant continues to be safe... Read More

SAN DIEGO, Aug. 04, 2023 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite” or the “Company”), a clinical stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting retinal degenerative eye diseases which have significant unmet medical needs, today announced that it will host a live webcast on Wednesday, August 9, 2023, at 4:30 p.m. Eastern Time to discuss the Company’s... Read More

Tinlarebant (a/k/a LBS-008) is Belite Bio’s orally administered tablet intended to slow disease progression in subjects with Stargardt Disease (STGD1) and Geographic Atrophy (GA) in advanced Dry Age-related Macular Degeneration (Dry AMD) There are no approved oral or non-invasive treatments for GA Enrollment of approximately 430 GA subjects across multiple centers globally SAN DIEGO, July 27, 2023 (GLOBE NEWSWIRE) -- Belite... Read More

Tinlarebant (a/k/a LBS-008) is Belite Bio’s orally administered tablet intended to slow disease progression in patients with Stargardt Disease (STGD1) and Geographic Atrophy (GA) in advanced Dry Age-related Macular Degeneration (Dry AMD) 90 patients completed enrollment across 11 countries worldwide Interim safety and efficacy data from the Phase 3 “DRAGON” trial for STGD1 is expected in mid-2024 Tinlarebant has been granted... Read More

SAN DIEGO, May 30, 2023 (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 retinal degenerative eye diseases which have significant unmet medical needs, today announced that it has priced an underwritten public offering of 2,000,000 American Depositary Shares (“ADSs”), each... Read More

SAN DIEGO, May 30, 2023 (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 retinal degenerative eye diseases which have significant unmet medical needs, today announced that it has commenced an underwritten public offering of American Depositary Shares (“ADSs”), each representing one... Read More

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 subjects A continued trend of slowing expansion of autofluorescence was observed and the growth rate of incident atrophic retinal... Read More

SAN DIEGO, May 10, 2023 (GLOBE NEWSWIRE) Belite Bio , Inc (NASDAQ: BLTE), a clinical stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting retinal degenerative eye diseases which have significant unmet medical needs, today announced it will host a live webcast on Thursday, May 11, 2023, at 8:00 a.m. Eastern Time to discuss the Company’s financial results for the first quarter... Read More

The webinar will take place on Wednesday, May 10, 2023 at 1:00 PM ET SAN DIEGO, May 04, 2023 (GLOBE NEWSWIRE) -- Belite Bio , Inc (NASDAQ: BLTE), a clinical stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting retinal degenerative eye diseases which have significant unmet medical needs, today announced it will host a virtual Key Opinion Leader event on focusing on adolescent... Read More

Tinlarebant (aka LBS-008) continues to be safe and well tolerated in adolescent Stargardt Disease (STGD1) subjects at the 18-month time point A continued trend of slowing expansion of autofluorescence was observed The growth rate of incident atrophic retinal lesions was reduced compared to a natural history study of the disease (“ProgStar”) Visual acuity was stabilized with no significant loss, and no clinically significant... Read More

Virtual event on Wednesday, May 3 rd at 1:00 PM ET will feature key opinion leader Hendrik Scholl, M.D. from the University of Basel, Switzerland 18-month interim efficacy and safety data from Belite Bio’s Phase 2 trial evaluating tinlarebant in Stargardt disease 1 will be discussed SAN DIEGO, April 11, 2023 (GLOBE NEWSWIRE) -- Belite Bio , Inc (NASDAQ: BLTE), a San Diego based clinical stage biopharmaceutical drug... Read More

12-month interim data from the ongoing 2-year, Phase 2 Stargardt disease (STGD1) study continues to show halting or slowing of lesion growth; 18-month efficacy and safety update expected during the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting on April 25 42 subjects have been enrolled for the pivotal Phase 3 “DRAGON” trial evaluating oral tinlarebant in adolescent STGD1; at least 90... Read More

SAN DIEGO, March 31, 2023 (GLOBE NEWSWIRE) -- Belite Bio , Inc (NASDAQ: BLTE), a San Diego based clinical stage biopharmaceutical drug development company targeting eye diseases with significant unmet medical needs, will host a live webcast on Monday, April 3, 2023, at 4:30 p.m. Eastern time to discuss the Company’s financial results for the full year ended December 31, 2022, and provide a general business update. The... Read More

Tinlarebant (a/k/a LBS-008) is Belite Bio’s orally administered tablet intended as an early intervention to slow disease progression in patients affected with Stargardt Disease (STGD1) and Dry Age-related Macular Degeneration (Dry AMD) There are currently no approved treatments for STGD1 and Dry AMD Currently, a 2-year Phase 2 study in adolescent STGD1 patients is ongoing and a global Phase 3 study in adolescent STGD1... Read More

“Potential Early Intervention with an Oral Treatment for Stargardt Disease and Dry Age-Related Macular Degeneration” Thursday, October 27 th at 11 AM ET Belite Bio, Inc (NASDAQ: BLTE), a San Diego based clinical stage biopharmaceutical drug development company targeting currently untreatable eye diseases, will host a key opinion leader (KOL) event with a focus on LBS-008 (aka Tinlarebant), the Company’s lead asset for the... Read More

LBS-008 (aka Tinlarebant) was safe and well tolerated in adolescent Stargardt Disease (STGD1) subjects at 12-month time point The majority of the subjects showed stabilization of BCVA in at least one eye A trend for preventing or slowing expansion of autofluorescence continue to be observed No atrophic lesion (DDAF) in 12 of 13 subjects at the 12-month treatment period 12-month interim data from the ongoing Phase 2 study... Read More

1-year interim data from the 2-year Phase 1b/2 trial of LBS-008 in adolescent STGD1 to be presented Belite Bio , Inc (NASDAQ: BLTE), a San Diego based clinical stage biopharmaceutical drug development company targeting currently untreatable eye diseases, today announced that the 1-year interim data from the 2-year Phase 1b/2 trial of LBS-008 in adolescent STGD1 will be presented at the “Late Breaking Development” session at... Read More

LBS-008 (aka Tinlarebant) is Belite Bio’s orally administered tablet for early intervention to maintain the health of retinal tissue in Stargardt disease (STGD1) and Dry AMD patients A 2-year Phase 2 trial in adolescent STGD1 and a global Phase 3 trial in adolescent STGD1 are ongoing The Phase 3 trial named “DRAGON” is a Multi-center, Randomized, Double Masked, Placebo Controlled Study to Evaluate the Safety and Efficacy of... Read More

LBS-008 (aka Tinlarebant) is Belite Bio’s orally administered tablet for the treatment of Stargardt disease (STGD1) and Dry AMD A 2-year Phase 2 trial in adolescent STGD1 and a global Phase 3 trial in adolescent STGD1 are ongoing The Phase 3, Multi-center, Randomized, Double Masked, Placebo Controlled Study to Evaluate the Safety and Efficacy of TinlaRebant in the Treatment of StArGardt Disease in AdOlesceNt Subjects... Read More

- LBS-008 (aka Tinlarebant) is Belite Bio’s orally administered tablet for the treatment of Stargardt disease (STGD1) and Dry AMD - A 2-year Phase 2 trial in adolescent STGD1 and a global Phase 3 trial in adolescent STGD1 are ongoing - The Phase 3, Multicenter, Randomized, D ouble Masked, Placebo Controlled Study to Evaluate the Safety and Efficacy of Tinla R ebant in the Treatment of St A r G ardt Disease in Ad O lesce N t... Read More

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,... Read More

LBS-008 (a/k/a Tinlarebant) is the Company’s orally administered tablet for the treatment of Stargardt disease (STGD1) There are currently no approved treatments for STGD1 Approximately 30,000 patients in the U.S. suffer from STGD1 A 2-year Phase 2 trial in adolescent STGD1 and a global Phase 3 trial in adolescent STGD1 are ongoing The Phase 3, Multicenter, Randomized, Double Masked, Placebo Controlled Study to Evaluate the... Read More

Belite Bio, Inc (NASDAQ: BLTE) (“Belite” or the “Company”), a clinical stage biopharmaceutical drug development company targeting currently untreatable eye diseases such as dry AMD and Stargardt disease, and metabolic diseases, today announced that the underwriters of its previously announced initial public offering (the “IPO”) have exercised in part their over-allotment option to purchase an additional 772,091 American... Read More

LBS-008 (aka Tinlarebant) showed an acceptable safety profile in adolescent Stargardt disease (STGD1) subjects A trend for stabilized or improved visual acuity was observed Observed adverse events were anticipated based on the mechanism of LBS-008 action STGD1 subjects from the Phase 1b study are now participating in the 2-year, Phase 2 extension Belite Bio , Inc (the “Company”) (Nasdaq: BLTE), a San Diego based clinical... Read More

Belite Bio, Inc (NASDAQ: BLTE) (“Belite” or the “Company”), a clinical stage biopharmaceutical drug development company targeting currently untreatable eye diseases such as dry AMD and Stargardt disease, and metabolic diseases, today announced the closing of its previously announced initial public offering of 6 million American Depositary Shares (ADSs) at a public offering price per ADS of $6.00. Each ADS represents one... Read More