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 |
|---|---|---|---|
| 1/26/2026 | $195.00 | Buy | BofA Securities |
| 1/6/2026 | $191.00 | Overweight | Morgan Stanley |
| 12/2/2025 | $194.00 | Neutral → Outperform | Mizuho |
| 11/24/2025 | $154.00 | Overweight | Cantor Fitzgerald |
| 11/20/2025 | $105.00 | Neutral | Mizuho |
| 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 |
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4 - BELITE BIO, INC (0001889109) (Issuer)
4 - BELITE BIO, INC (0001889109) (Issuer)
4 - BELITE BIO, INC (0001889109) (Issuer)
4 - BELITE BIO, INC (0001889109) (Issuer)
4 - BELITE BIO, INC (0001889109) (Issuer)
4 - BELITE BIO, INC (0001889109) (Issuer)
4 - BELITE BIO, INC (0001889109) (Issuer)
4 - BELITE BIO, INC (0001889109) (Issuer)
4 - BELITE BIO, INC (0001889109) (Issuer)
4 - BELITE BIO, INC (0001889109) (Issuer)
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BofA Securities initiated coverage of Belite Bio with a rating of Buy and set a new price target of $195.00
Morgan Stanley initiated coverage of Belite Bio with a rating of Overweight and set a new price target of $191.00
Mizuho upgraded Belite Bio from Neutral to Outperform and set a new price target of $194.00
Cantor Fitzgerald resumed coverage of Belite Bio with a rating of Overweight and set a new price target of $154.00
Mizuho initiated coverage of Belite Bio with a rating of Neutral and set a new price target of $105.00
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
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Tinlarebant is the first therapeutic candidate to demonstrate clinical efficacy in Stargardt disease type 1, having met the primary efficacy endpoint, reduction in lesion growth Presentation to include positive update on secondary endpoints, with quantitative autofluorescence showing a marked divergence between treatment groupsNew Drug Application to the U.S. Food and Drug Administration for tinlarebant completed SAN DIEGO, July 20, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ:BLTE) ("Belite Bio®" 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
SAN DIEGO, July 15, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ:BLTE) ("Belite Bio®" 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 Company will participate in a panel discussion at the H.C. Wainwright 6th Annual Ophthalmology Virtual Conference on Wednesday, July 22, 2026, at 3:00 pm ET. Webcast Link InstructionsA webcast of the panel can be accessed under "Events" in the investor relations section of the Belite Bio website at: https://investors.belitebio.com/presentations-events/events. The replay will be archived for 90 d
SAN DIEGO, July 06, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ:BLTE) ("Belite Bio®" 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 Company will participate in a fireside chat at the Piper Sandler Virtual Ophthalmology Investor Symposium on Thursday, July 9, 2026, at 12:30 pm ET. Webcast Link InstructionsA webcast of the presentation can be accessed under "Events" in the investor relations section of the Belite Bio website at: https://investors.belitebio.com/presentations-events/events. The replay will be archived for 90 day
SAN DIEGO, July 06, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ:BLTE) ("Belite Bio®" 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 Belite data will be presented at the 63rd Annual Symposium of the International Society for Clinical Electrophysiology of Vision (ISCEV) being held on July 6-11, 2026, in Sydney, Australia, and the American Society of Retina Specialists (ASRS) 2026 Annual Meeting being held on July 15-18, 2026, in Montréal, Canada. Presentation DetailsSession: Session 2: Inherited Retinal Disorders (IRD) cont.Title:
SAN DIEGO, June 12, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ:BLTE) ("Belite Bio®" 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 the completion of its rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tinlarebant. Tinlarebant is an investigational, once-daily oral therapy for the treatment of Stargardt disease type 1 (STGD1), a rare, inherited retinal disease caused by mutations in the ABCA4 gene that leads to progressive and irreversible vision loss. STGD1 affects an estimated 53
SAN DIEGO, June 02, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ:BLTE) ("Belite Bio®" 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 Company will participate in a fireside chat at the Goldman Sachs 47th Annual Global Healthcare Conference on Monday, June 8, 2026 at 4:00 pm ET. Webcast Link InstructionsWebcasts of the presentations can be accessed under "Events" in the investor relations section of the Belite Bio website at: https://investors.belitebio.com/presentations-events/events. The replays will be archived for 90 days f
Initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tinlarebant for the treatment of Stargardt disease type 1 (STGD1); submission expected to be completed in the second quarter of 2026Commercialization preparation for STGD1 underway; hiring of all key commercial leadership positions completed Cash and cash equivalents, U.S. treasury bills and notes: $798.6 million as of March 31, 2026Conference call and webcast on Wednesday, May 20, 2026, at 4:30 p.m. ET SAN DIEGO, May 20, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ:BLTE) ("Belite Bio®" or the "Company"), a clinical-stage drug development company focused on advancing nov
Tinlarebant is the first therapeutic candidate to demonstrate clinical efficacy in Stargardt disease, having met the primary endpoint, reductions in lesion growth rate, in the pivotal, global Phase 3 DRAGON trial Company recently initiated a rolling submission of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA), which it expects to complete in 2Q 2026 Tinlarebant has previously 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 the treatment of Stargardt disease SAN DIEGO, May 18, 2026 (GLOBE NEWSWIRE) -- Belite Bi
SAN DIEGO, May 15, 2026 (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 the Company will give an oral presentation at the 27th Fundus Disease Forum and International Retinal Symposium (Retina China 2026) being held from May 21-23, 2026, in Nanjing, China. The presentation will cover the previously disclosed positive topline results from the Phase 3 DRAGON trial, which evaluated tinlarebant for the treatment of Stargardt disease type 1 (STGD1). In the
SAN DIEGO, May 13, 2026 (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 will host a webcast on Wednesday, May 20, 2026, at 4:30 p.m. Eastern Time to discuss the Company's financial results and provide a business update for the first quarter ended March 31, 2026. Webcast InformationDate: Wednesday, May 20, 2026Time: 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time)Webcast Link: https://events.q4inc.com/attendee/135456520 Webcast Link InstructionsYou
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Live Leadership Updates
Initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tinlarebant for the treatment of Stargardt disease type 1 (STGD1); submission expected to be completed in the second quarter of 2026Commercialization preparation for STGD1 underway; hiring of all key commercial leadership positions completed Cash and cash equivalents, U.S. treasury bills and notes: $798.6 million as of March 31, 2026Conference call and webcast on Wednesday, May 20, 2026, at 4:30 p.m. ET SAN DIEGO, May 20, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ:BLTE) ("Belite Bio®" or the "Company"), a clinical-stage drug development company focused on advancing nov
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
Live finance-specific insights
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