Belite Bio, Inc American Depositary Shares

Belite 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 Pha...

Belite 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 ...

Belite 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...

Belite 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 Fa...

Belite 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 Ph...