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BELITE BIO, INC Create: Alert

All | News | Filings
Date FiledTypeDescription
08/09/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "FORM 6-K",
"Belite Bio Reports Second Quarter 2023 Operational Highlights and Financial Results · Completed enrollment in pivotal Phase 3 “DRAGON” trial for Tinlarebant in adolescent Stargardt disease with 100 subjects enrolled across 11 countries worldwide · First subject dosed with Tinlarebant in pivotal global Phase 3 “PHOENIX” trial in Geographic Atrophy · Oral, once-daily Tinlarebant continues to be safe and well tolerated, slowing expansion of autofluorescence, reducing incident atrophic retinal lesion growth rate, and stabilizing visual acuity up to 18-months in Phase 2 STGD1 trial · Strengthened balance sheet with $30 million of gross proceeds from the underwritten public offering · Final 2-year data of LBS-008-CT02 in STGD1 expected in Q4 2023 and interim Ph..."
07/24/2023 6-K Quarterly results
06/16/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "FORM 6-K",
"Sales Agreement, by and between Belite Bio, Inc and SVB Securities LLC and Cantor Fitzgerald & Co",
"Opinion of Maples and Calder (Hong Kong) LLP"
05/10/2023 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "FORM 6-K",
"Belite Bio Reports First-Quarter 2023 Operational Highlights and Financial Results"
04/25/2023 6-K Quarterly results
12/13/2022 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "FORM 6-K",
"Securities and Exchange Commission 100 F Street, N.E."
11/18/2022 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "FORM 6-K",
"Belite Bio Finalizes Phase 3 Clinical Trial Plans for Advanced Dry AMD Treatment with Tinlarebant · Tinlarebant is Belite Bio’ s orally administered tablet intended as an early intervention to slow disease progression in patients affected with Stargardt Disease and Dry Age-related Macular Degeneration · There are currently no approved treatments for STGD1 and Dry AMD · Currently, a 2-year Phase 2 study in adolescent STGD1 patients is ongoing and a global Phase 3 study in adolescent STGD1 patients is recruiting subjects · 12-month interim data from the ongoing Phase 2 STGD1study continues to show halting or slowing of lesion growth · Tinlarebant has been granted Fast Track Designation and Rare Pediatric Disease Designation in the U.S., and Orphan Drug Desi..."
10/03/2022 6-K Quarterly results
09/16/2022 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "FORM 6-K",
"Belite Bio Receives Approval of LBS-008 Phase 3 Clinical Trial in China · LBS-008 is Belite Bio’ s orally administered tablet for early intervention to maintain the health of retinal tissue in Stargardt disease and Dry AMD patients · A 2-year Phase 2 trial in adolescent STGD1 and a global Phase 3 trial in adolescent STGD1 are ongoing · The Phase 3 trial named “DRAGON” is a Multi-center, Randomized, Double Masked, Placebo Controlled Study to Evaluate the Safety and Efficacy of TinlaRebant in the Treatment of StArGardt Disease in AdOlesceNt Subjects has commenced in the U.S., the United Kingdom, Germany, Belgium, Switzerland, Hong Kong, Taiwan, and Australia, with several patients already enrolled · LBS-008, Belite Bio’ s lead asset, has been granted Fast Track De..."
08/22/2022 6-K Quarterly results
08/10/2022 6-K Quarterly results
07/19/2022 6-K Quarterly results
05/12/2022 6-K Quarterly results
05/03/2022 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "FORM 6-K",
"Belite Bio Receives FDA Fast Track Designation For LBS-008"

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