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BL

Mkt Cap

$5.76B

Volume

164.59K

Next Earnings

November 9th

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BLTEBelite Bio, Inc American Depositary Shares

BLTE

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BL

Mkt Cap

$6.15B

Volume

164.59K

Next Earnings

November 9th

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Belite Bio to Host Virtual Commercial Day on September 2, 2026Belite Bio announced that the FDA accepted and granted Priority Review designation for its New Drug Application for tinlarebant to treat Stargardt disease type 1 (STGD1), with a decision date set for February 12, 2027. The company will host a Virtual Commercial Day on September 2, 2026, to discuss the drug's commercial opportunity and prelaunch preparedness strategies.GlobeNewswire Inc. · Aug 24, 2026

Belite Bio to Participate in the Piper Sandler Virtual Ophthalmology Investor SymposiumBelite Bio, a clinical-stage drug development company, announced it will participate in a fireside chat at the Piper Sandler Virtual Ophthalmology Investor Symposium on July 9, 2026. The company is advancing tinlarebant, an oral therapy for degenerative retinal diseases including Stargardt disease type 1 and geographic atrophy, with completed Phase 3 trials and ongoing Phase 2/3 and Phase 3 trials.GlobeNewswire Inc. · Jul 6, 2026

Belite Bio Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt Disease Type 1Belite Bio announced the completion of its rolling NDA submission to the FDA for tinlarebant, an oral therapy for Stargardt disease type 1 (STGD1), a rare inherited retinal disease affecting approximately 53,000 people in the U.S. with no current approved treatments. The submission was made under Breakthrough Therapy Designation and will undergo a 60-day FDA review period. The Phase 3 DRAGON trial demonstrated tinlarebant's ability to significantly reduce the growth rate of retinal lesions compared to placebo.GlobeNewswire Inc. · Jun 13, 2026

Belite Bio Reports Unaudited First Quarter 2026 Financial Results and Provides a Corporate UpdateBelite Bio initiated a rolling NDA submission to the FDA for tinlarebant to treat Stargardt disease type 1 (STGD1), with completion expected in Q2 2026. The company reported Q1 2026 results showing $798.6 million in cash and investments, increased R&D and SG&A expenses due to commercialization preparation and team expansion, and a net loss of $26.9 million (GAAP). Key commercial leadership positions have been hired as the company prepares for potential market launch.GlobeNewswire Inc. · May 20, 2026

Belite Bio Receives Orphan Drug Status for Tinlarebant in Stargardt Disease in SwitzerlandBelite Bio announced that tinlarebant, its lead product candidate for Stargardt disease, has received orphan drug status from Switzerland's Swissmedic. The drug previously demonstrated a 35.7% reduction in retinal lesion growth rate in the Phase 3 DRAGON trial and has received multiple regulatory designations including Breakthrough Therapy and Fast Track designations in the U.S. The company is rolling out an NDA submission with the FDA expected to complete in Q2 2026.GlobeNewswire Inc. · May 18, 2026

Belite Bio to Host Webcast on May 20, 2026, to Discuss First Quarter 2026 Financial ResultsBelite Bio, Inc. (NASDAQ: BLTE), a clinical-stage biopharmaceutical company developing therapeutics for degenerative retinal diseases, announced a webcast scheduled for May 20, 2026, at 4:30 p.m. ET to discuss Q1 2026 financial results and provide a business update. The company's lead candidate, tinlarebant, is being evaluated in Phase 2/3 and Phase 3 trials for Stargardt disease type 1 and geographic atrophy.GlobeNewswire Inc. · May 13, 2026

Belite Bio Initiates Rolling Submission of New Drug Application to the U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt DiseaseBelite Bio has initiated a rolling submission of a New Drug Application (NDA) to the FDA for tinlarebant, an oral therapy for treating Stargardt disease type 1 (STGD1). The drug has received Breakthrough Therapy Designation and could become the first approved treatment for this rare inherited retinal disorder. The company expects to complete the NDA submission in Q2 2026 and is preparing for potential commercialization in 2027.GlobeNewswire Inc. · Apr 21, 2026

Belite Bio Announces Pricing of $350.0 Million Underwritten Public Offering of American Depositary SharesBelite Bio has priced a public offering of 2,272,727 American Depositary Shares at $154.00 per share, expecting to raise approximately $350 million to fund commercialization preparation, pipeline development, and general corporate purposes.GlobeNewswire Inc. · Dec 2, 2025

Geographic Atrophy Market to Surge Significantly During the Forecast Period (2025–2034) Due to Rising Adoption of Complement Inhibitor Therapies | DelveInsightThe geographic atrophy market is expected to grow significantly due to rising global prevalence, aging populations, and emerging therapies targeting this advanced form of age-related macular degeneration.GlobeNewswire Inc. · Dec 1, 2025

Dry Age-related Macular Degeneration Market Poised for Rapid Growth During the Forecast Period (2025–2034) Amid Expanding Treatment Landscape | DelveInsightThe dry AMD market is expected to grow significantly by 2034, driven by emerging therapies, increasing diagnosis rates, and novel treatment approaches targeting geographic atrophy.GlobeNewswire Inc. · Nov 17, 2025

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