$BLTE News
Last published 1d ago
- 1d agoBLTEBelite Bio Reports Unaudited Third Quarter 2026 Financial Results and Provides a Corporate UpdateGlobeNewswireSAN DIEGO, Nov. 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 its financial results for the third quarter ended September 30, 2026, and provided a business update.
- 1w agoBLTEBelite Bio to Host Webcast on November 12, 2026, to Discuss Third Quarter 2026 Financial ResultsGlobeNewswireSAN DIEGO, Nov. 05, 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
- 3w agoBLTEBelite Bio Announces Uplisting to the Nasdaq Global Select MarketGlobeNewswireSAN DIEGO, Oct. 19, 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
- 4w agoBLTEBelite Bio Announces Multi-Market Submission of Marketing Authorization Applications Via the Access Consortium Pathway for Tinlarebant for the Treatment of Stargardt Disease Type 1GlobeNewswireIf 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
- 2mo agoBLTEBelite Bio Morgan Stanley 24th Annual Global Healthcare Conference - BELITE BIO INCEarnings Call TranscriptsAll right, welcome everyone to this session of the Morgan Stanley Global Healthcare Conference. We're very excited to have B-Lite with us this morning with Haruan and Hendrik representing the company, so thanks for being
- 2mo agoBLTEMorgan Stanley 24th Annual Global Healthcare Conference - BELITE BIO INCEarnings Call TranscriptsAll right, welcome everyone to this session of the Morgan Stanley Global Healthcare Conference. We're very excited to have B-Lite with us this morning with Haruan and Hendrik representing the company, so thanks for being
- 2mo agoBLTEBelite 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 1GlobeNewswireU.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,
- 2mo agoBLTEBelite Bio 2026 Commercial Day - BELITE BIO INCEarnings Call TranscriptsLadies and gentlemen, thank you for joining us and welcome to the BeLightBio 2026 Commercial Day. After today's prepared remarks, we will host a question and answer session. If you would like to ask a question, please ra
- 2mo agoBLTEBelite Bio to Participate in Four Upcoming Investor ConferencesGlobeNewswireSAN 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
- 2mo agoBLTEBelite Bio to Host Virtual Commercial Day on September 2, 2026GlobeNewswireSAN 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
- 2mo agoBLTEBelite Bio Announces Oral Presentations at Two Upcoming Medical ConferencesGlobeNewswireSAN 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
- 3mo agoBLTEBLTE 2Q26 Earnings Call - BELITE BIO INCEarnings Call TranscriptsLadies and gentlemen, thank you for joining us and welcome to the BeLightBio second quarter 2026 earnings call. After today's prepared remarks, we will host a question and answer session. If you would like to ask a quest
- 3mo agoBLTEBelite Bio Reports Unaudited Second Quarter 2026 Financial Results and Provides a Corporate UpdateGlobeNewswireU.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
- 3mo agoBLTEBelite 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 1GlobeNewswirePrescription 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) --
- 3mo agoBLTEBelite Bio to Host Webcast on August 13, 2026, to Discuss Second Quarter 2026 Financial ResultsGlobeNewswireSAN 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
- 3mo agoBLTEBelite 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 1GlobeNewswireTinlarebant 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
- 4mo agoBLTEBelite Bio to Participate in the H.C. Wainwright 6th Annual Ophthalmology Virtual ConferenceGlobeNewswireSAN 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
- 4mo agoBLTEBelite Bio to Participate in the Piper Sandler Virtual Ophthalmology Investor SymposiumGlobeNewswireSAN 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
- 4mo agoBLTEBelite Bio Announces Oral Presentations at Two Upcoming Medical ConferencesGlobeNewswireSAN 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
- 5mo agoBLTEBelite Bio Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt Disease Type 1GlobeNewswireSAN 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
- 5mo agoBLTEBelite Bio to Participate in the Goldman Sachs 47th Annual Global Healthcare ConferenceGlobeNewswireSAN 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
- 5mo agoBLTEBLTE 1Q26 Earnings CallBELITE BIO INCEarnings Call TranscriptsLadies and gentlemen, thank you for joining us and welcome to the BeLightBio First Quarter 2026 Earnings Call. After today's prepared remarks, we will host a question and answer session. If you would like to ask a questi
- 5mo agoBLTEBelite Bio Reports Unaudited First Quarter 2026 Financial Results and Provides a Corporate UpdateGlobeNewswireInitiated 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
- 5mo agoBLTEBelite Bio Receives Orphan Drug Status for Tinlarebant in Stargardt Disease in SwitzerlandGlobeNewswireTinlarebant 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
- 6mo agoBLTEBelite Bio Announces Oral Presentation at the 27th Fundus Disease Forum and International Retinal Symposium (Retina China 2026)GlobeNewswireSAN 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
- 6mo agoBLTE2026 GLOBAL HEALTHCARE CONFERENCEBELITE BIO INCEarnings Call TranscriptsOkay. Good afternoon. Welcome back to the Bank of America Healthcare Conference. I'm Tazina Maad. I am one of the senior biotech analysts here at the bank. It's my pleasure to have our next presenting company, BeLightBio
- 6mo agoBLTEBelite Bio to Host Webcast on May 20, 2026, to Discuss First Quarter 2026 Financial ResultsGlobeNewswireSAN 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
- 6mo agoBLTEBelite Bio Announces Oral Presentation at the Retinal Therapeutics Innovation SummitGlobeNewswireSAN DIEGO, April 27, 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
- 6mo agoBLTEBelite Bio to Participate in Four Upcoming Investor ConferencesGlobeNewswireSAN DIEGO, April 23, 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
- 6mo agoBLTEBelite Bio to Present at the Deutsche Bank American Depositary Receipt Virtual Investor Conference on April 28thGlobeNewswireSAN DIEGO, April 22, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ:BLTE) a clinical stage development company based in San Diego and focused on advancing novel therapeutics targeting degenerative retinal diseases
- 6mo agoBLTEBelite Bio Initiates Rolling Submission of New Drug Application to the U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt DiseaseGlobeNewswireBelite expects to complete the new drug application submission in the second quarter of 2026Rolling submission initiated under Breakthrough Therapy Designation SAN DIEGO, April 21, 2026 (GLOBE NEWSWIRE) -- Belite
- 7mo agoBLTEBelite Bio Announces Availability of Annual Report on Form 20-F Through Company WebsiteGlobeNewswireSAN DIEGO, March 31, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ:BLTE), a clinical-stage development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant
- 8mo agoBLTEBelite Bio to Participate in the Leerink Global Healthcare ConferenceGlobeNewswireSAN DIEGO, March 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
- 8mo agoBLTEBelite Bio Reports Preliminary, Unaudited Fourth Quarter and Full Year 2025 Financial Results and Provides a Corporate UpdateGlobeNewswireFollowing positive topline results from the pivotal, global Phase 3 DRAGON trial of tinlarebant in adolescents with Stargardt disease type 1 (STGD1), the Company is on track to submit a New Drug Application (NDA) to the
- 8mo agoBLTEBelite Bio to Host Webcast on March 2, 2026, to Discuss Preliminary, Unaudited Fourth Quarter and Full Year 2025 Financial ResultsGlobeNewswireSAN DIEGO, Feb. 23, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ:BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have
- 9mo agoBLTEBelite Bio Announces Participation at the 41st Asia-Pacific Academy of Ophthalmology Congress (APAO)GlobeNewswireSAN DIEGO, Jan. 29, 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
- 9mo agoBLTEBelite Bio Completes Enrollment in the DRAGON II Clinical Trial of Tinlarebant for Stargardt Disease (STGD1)GlobeNewswireTinlarebant is the first therapeutic candidate to demonstrate clinical efficacy in Stargardt disease, having met the primary endpoint in the pivotal, global Phase 3 DRAGON trial with 36% reduction in lesion growth
- 11mo agoBLTEBelite Bio Announces Pricing of $350.0 Million Underwritten Public Offering of American Depositary SharesGlobeNewswireSAN DIEGO, Dec. 01, 2025 (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
- 11mo agoBLTEBelite Bio Announces Proposed Underwritten Public Offering of American Depositary SharesGlobeNewswireSAN DIEGO, Dec. 01, 2025 (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
- 11mo agoBLTENew Hope for People Living with a Disease Once Deemed Untreatable: Belite Bio Announces Positive Topline Results from the Pivotal Global, Phase 3 DRAGON Trial of Tinlarebant in Adolescents with Stargardt DiseaseGlobeNewswireTinlarebant 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
- 1y agoBLTEBelite Bio Reports Third Quarter 2025 Financial Results and Provides a Corporate UpdateGlobeNewswireCompleted 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
- 1y agoBLTEBelite Bio to Host Webcast on November 10, 2025, to Discuss Third Quarter 2025 Financial ResultsGlobeNewswireSAN 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
- 1y agoBLTEBelite Bio Announces UK's Medicines and Healthcare Products Regulatory Agency Agrees to Conditional Marketing Authorization Application Based on Interim Analysis Results for the Treatment of Stargardt Disease with TinlarebantGlobeNewswireMHRA 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
- 1y agoBLTEBelite Bio to Present at the dbVIC - Deutsche Bank ADR Virtual Investor Conference November 4thGlobeNewswireSAN DIEGO, Oct. 29, 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
- 1y agoBLTEBelite Bio to Participate in the Deutsche Bank ADR Virtual Investor ConferenceGlobeNewswireSAN DIEGO, Oct. 29, 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
- 1y agoBLTEBelite Bio to Participate in the 2025 Maxim Growth SummitGlobeNewswireSAN 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
- 1y agoBLTEBelite Bio Announces China NMPA Agrees to New Drug Application with Priority Review based on Interim Analysis Results for the Treatment of Stargardt Disease with TinlarebantGlobeNewswireNMPA's response is based on the Phase 3 DRAGON interim analysis resultsTopline final data expected in Q4 2025 SAN DIEGO, Oct. 15, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ:BLTE), a clinical-stage drug
- 1y agoBLTEBelite Bio Announces Completion of DRAGON, a 2-Year, Phase 3 Trial of Oral Tinlarebant in the Treatment of Stargardt DiseaseGlobeNewswireTinlarebant 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
- 1y agoBLTEBelite Bio Announces Up to $275 Million Upsized Private Placement Financing by Leading Healthcare InvestorsGlobeNewswireTransaction 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
- 1y agoBLTEBelite Bio to Participate in Three Upcoming Investor ConferencesGlobeNewswireSAN 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