Price$142.68-7.07 (-4.72%)
2026-07-162026-10-16
News · 26 weeks58-57%
2026-04-192026-10-11
Mix1990d
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Latest news
25 items- PRBelite Bio Announces Multi-Market Submission of Marketing Authorization Applications Via the Access Consortium Pathway for Tinlarebant for the Treatment of Stargardt Disease Type 1If approved, tinlarebant would be the first-ever approved treatment for Stargardt Disease Type 1 in Singapore, United Kingdom, and SwitzerlandAccess pathway submission combined with accepted new drug applications in the U.S. (Prescription Drug User Fee Act target action date of February 12, 2027) and in Japan, further advance the Company’s goal to bring tinlarebant to Stargardt disease type 1 patients around the world SAN DIEGO, Oct. 14, 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, t
- INSIDERSEC Form 4 filed by Belite Bio Inc4 - BELITE BIO, INC (0001889109) (Issuer)
- PRBelite Bio Announces Oral Presentations at Two Upcoming Medical ConferencesSAN DIEGO, Sept. 28, 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 its data will be presented at the Euretina Innovation Spotlight (EIS) being held on September 30, 2026, and Euretina being held on October 1-4, 2026, in Vienna, Austria. EIS Presentation DetailsSession: EURETINA Innovation Spotlight – Inherited and Rare Retinal DiseasesTitle: Belite Bio Company OverviewPresenter: Hendrik Scholl, M.D., Chief Medical Officer, Belite BioDate and Time: September 30, 20
- INSIDERChief Executive Officer Lin Yu-Hsin sold $19,082,549 worth of American depositary share (100,435 units at $190.00) as part of a pre-agreed trading plan, decreasing direct ownership by 59% to 70,134 units (SEC Form 4)4 - BELITE BIO, INC (0001889109) (Issuer)
- INSIDERChief Financial Officer Chuang Hao-Yuan sold $12,803,528 worth of American depositary share (67,395 units at $189.98) as part of a pre-agreed trading plan, decreasing direct ownership by 72% to 26,038 units (SEC Form 4)4 - BELITE BIO, INC (0001889109) (Issuer)
- SECSEC Form 6-K filed by Belite Bio Inc6-K - BELITE BIO, INC (0001889109) (Filer)
- PRBelite Bio Announces Submission of New Drug Application to the Ministry of Health, Labour, and Welfare in Japan under the Sakigake Designation System for Tinlarebant for the Treatment of Stargardt Disease Type 1U.S. Food and Drug Administration accepted the New Drug Application with Priority Review for tinlarebant for the treatment of Stargardt disease type 1; Prescription Drug User Fee Act target action date of February 12, 2027If approved, tinlarebant would be the first-ever approved treatment for Stargardt Disease Type 1 and could become the first Sakigake pharmaceutical product for ophthalmology disease in Japan SAN DIEGO, Sept. 08, 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 a
- ANALYSTCanaccord Genuity initiated coverage on Belite Bio with a new price targetCanaccord Genuity initiated coverage of Belite Bio with a rating of Buy and set a new price target of $303.00
- PRBelite Bio to Participate in Four Upcoming Investor ConferencesSAN DIEGO, Sept. 01, 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 four upcoming investor conferences. Details of the presentations are as follows: Wells Fargo 21st Annual Healthcare Conference (Boston, MA) September 8, 2026, at 8:45 am ET, fireside chat 2026 Cantor Global Healthcare Conference (New York, NY) September 11, 2026, at 10:55 am ET, fireside chat Morgan Stanley 24th Annual Global Healthcare Conference (New York,
- PRBelite Bio to Host Virtual Commercial Day on September 2, 2026SAN DIEGO, Aug. 24, 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 it will host a Virtual Commercial Day on Wednesday, September 2, 2026, from 8:00 – 9:30 a.m. ET. Belite Bio’s management team will be joined by leading experts in ophthalmology and people living with Stargardt disease type 1 (STGD1), and will provide an overview of STGD1, the unmet need of people living with the disease, and the current treatment landscape. Management will also provide an update on
- PRBelite Bio Announces Oral Presentations at Two Upcoming Medical ConferencesSAN DIEGO, Aug. 21, 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 its data will be presented at the Schweizerische Ophthalmologische Gesellschaft (SOG) Annual Congress being held on August 26-28, 2026, in Lausanne, Switzerland and the 19th Asia-Pacific Vitreo-retina Society (APVRS) Congress being held on August 28-30, 2026, in Gold Coast, Australia. SOG Presentation DetailsSession: Free Communications I – Retina VitreousTitle: Results from the Phase 3 Dragon Study
- INSIDERChief Financial Officer Chuang Hao-Yuan sold $66,187 worth of American depositary share (367 units at $180.35) as part of a pre-agreed trading plan, decreasing direct ownership by 0.39% to 93,433 units (SEC Form 4)4 - BELITE BIO, INC (0001889109) (Issuer)
- INSIDERChief Executive Officer Lin Yu-Hsin sold $65,827 worth of American depositary share (365 units at $180.35) as part of a pre-agreed trading plan, decreasing direct ownership by 0.21% to 170,569 units (SEC Form 4)4 - BELITE BIO, INC (0001889109) (Issuer)
- SECSEC Form 6-K filed by Belite Bio Inc6-K - BELITE BIO, INC (0001889109) (Filer)
- PRBelite Bio Reports Unaudited Second Quarter 2026 Financial Results and Provides a Corporate UpdateU.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) with Priority Review for tinlarebant for the treatment of Stargardt disease type 1 (STGD1); Prescription Drug User Fee Act (PDUFA) target action date of February 12, 2027Company presented additional positive secondary endpoint data from the Phase 3 DRAGON trial of tinlarebant at the American Society of Retina Specialists (ASRS) Annual Meeting with quantitative autofluorescence (qAF) showing a marked divergence between treatment groupsConference call and webcast on Thursday, August 13, 2026, at 4:30 p.m. ET SAN DIEGO, Aug. 12, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ:BLTE) ("Belite Bio®" or the "Company
- SECSEC Form 6-K filed by Belite Bio Inc6-K - BELITE BIO, INC (0001889109) (Filer)
- PRBelite Bio Announces U.S. Food and Drug Administration Acceptance and Priority Review of New Drug Application for Tinlarebant for the Treatment of Stargardt Disease Type 1Prescription Drug User Fee Act target action date is February 12, 2027If approved, tinlarebant would be the first-ever approved treatment for Stargardt Disease Type 1 SAN DIEGO, Aug. 11, 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 U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review designation of the New Drug Application (NDA) for tinlarebant for the treatment of Stargardt Disease Type 1 (STGD1). The FDA has set a Prescription Dr
- PRBelite Bio to Host Webcast on August 13, 2026, to Discuss Second Quarter 2026 Financial ResultsSAN DIEGO, Aug. 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 it will host a webcast on Thursday, August 13, 2026, at 4:30 p.m. Eastern Time to discuss the Company’s financial results and provide a business update for the second quarter ended June 30, 2026. Webcast InformationDate: Thursday, August 13, 2026Time: 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time)Webcast Link: https://events.q4inc.com/attendee/449343673 Webcast Link InstructionsYou can join the li
- PRBelite Bio Announces Oral Presentation at the ASRS Annual Meeting Featuring Additional Positive Secondary Endpoint Data from the Phase 3 Trial of Tinlarebant in Stargardt Disease Type 1Tinlarebant 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
- PRBelite Bio to Participate in the H.C. Wainwright 6th Annual Ophthalmology Virtual ConferenceSAN 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
- PRBelite Bio to Participate in the Piper Sandler Virtual Ophthalmology Investor SymposiumSAN 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
- PRBelite Bio Announces Oral Presentations at Two Upcoming Medical ConferencesSAN 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:
- INSIDERChief Medical Officer Scholl Hendrik Peter sold $1,452,435 worth of American depositary share (10,000 units at $145.24) (SEC Form 4)4 - BELITE BIO, INC (0001889109) (Issuer)
- INSIDERChief Medical Officer Scholl Hendrik Peter sold $1,405,729 worth of American depositary share (10,000 units at $140.57) (SEC Form 4)4 - BELITE BIO, INC (0001889109) (Issuer)
- SECSEC Form 6-K filed by Belite Bio Inc6-K - BELITE BIO, INC (0001889109) (Filer)
BLTE FAQ
7 questionsWhat does Belite Bio Inc do?
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...Where does BLTE stock trade?
Belite Bio Inc (BLTE) is listed on NASDAQ.What sector and industry is BLTE in?
Belite Bio Inc operates in the Health Care sector, Biotechnology: Pharmaceutical Preparations industry.When did Belite Bio Inc go public?
Belite Bio Inc (BLTE) completed its IPO in 2022.What are analysts saying about BLTE?
Belite Bio Inc has had 8 recent analyst actions on file. The most recent action was from Canaccord Genuity: Buy on 2026-09-04. Recent price targets cluster around $4300.00.What companies are similar to BLTE?
Notable peers in the same industry include LLY (Eli Lilly and Company), JNJ (Johnson & Johnson), ABBV (AbbVie Inc.), MRK (Merck & Company Inc.), NVS (Novartis AG). Compare BLTE side-by-side with any of them on Quantisnow.How can I track BLTE on Quantisnow?
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