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 2026 Commercialization preparation for STGD1 underway;
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
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
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
SAN 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 targeting degenerative retinal diseases that have significant unmet medical needs,
SAN 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 retinal diseases that have significant unmet medical needs, today announced that the
Belite expects to complete the new drug application submission in the second quarter of 2026 Rolling submission initiated under Breakthrough Therapy Designation SAN DIEGO, April 21, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio” or the “Company”), a clinical-stage drug
SAN 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 unmet medical needs, today announced that its annual report on Form 20-F,
SAN 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 retinal diseases that have significant unmet medical needs, today announced that
Following 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 U.S. Food and Drug Administration (FDA) in Q2 2026 Completed enrollment in the
SAN 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 significant unmet medical needs, today announced that it will host a webcast on Monday,
SAN 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 retinal diseases that have significant unmet medical needs, today announced that the
Tinlarebant 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 (p-value=0.0033) 60 adolescent STGD1 subjects enrolled in DRAGON II clinical trial
SAN 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 retinal diseases that have significant unmet medical needs, today announced that it