{"filing":{"accession_number":"0001104659-26-105608","cik":"0001889109","ticker":"BLTE","company_name":"BELITE BIO, INC","form":"6-K","filing_date":"2026-09-08","report_date":"2026-09-08","primary_document":"tm2624806d1_6k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1889109/000110465926105608/tm2624806d1_6k.htm"},"events":[{"id":31719,"run_id":29121,"accession_number":"0001104659-26-105608","anchor_item_number":"EX-99.1","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"summary":"Belite Bio announced submission of a New Drug Application (NDA) to Japan's Ministry of Health, Labour, and Welfare for tinlarebant under the Sakigake expedited designation system, alongside FDA acceptance of a U.S. NDA with Priority Review. This is a material regulatory milestone for a clinical-stage company's lead candidate, representing significant progress toward potential first-ever approval for Stargardt Disease Type 1. The event is operational/strategic (regulatory advancement) rather than a discrete financial, governance, or legal event, and does not fit the specific categories of earnings, M\u0026A, or other named types.","company_name":"BELITE BIO, INC","ticker":"BLTE","filing_date":"2026-09-08","form":"6-K","submitted_at":null,"items":[{"id":34682,"accession_number":"0001104659-26-105608","item_number":"EX-99.1","item_title":"tm2624806d1_ex99-1.htm","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"reasoning":"Belite Bio announced submission of a New Drug Application (NDA) to Japan's Ministry of Health, Labour, and Welfare for tinlarebant under the Sakigake expedited designation system, alongside FDA acceptance of a U.S. NDA with Priority Review. This is a material regulatory milestone for a clinical-stage company's lead candidate, representing significant progress toward potential first-ever approval for Stargardt Disease Type 1. The event is operational/strategic (regulatory advancement) rather than a discrete financial, governance, or legal event, and does not fit the specific categories of earnings, M\u0026A, or other named types.","classifier_version":"claude-haiku-4-5-20251001+prompt-6be895f9","taxonomy_version":"v1.3","classified_at":"2026-09-08T10:09:41.930463+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":34682,"accession_number":"0001104659-26-105608","item_number":"EX-99.1","item_title":"tm2624806d1_ex99-1.htm","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"reasoning":"Belite Bio announced submission of a New Drug Application (NDA) to Japan's Ministry of Health, Labour, and Welfare for tinlarebant under the Sakigake expedited designation system, alongside FDA acceptance of a U.S. NDA with Priority Review. This is a material regulatory milestone for a clinical-stage company's lead candidate, representing significant progress toward potential first-ever approval for Stargardt Disease Type 1. The event is operational/strategic (regulatory advancement) rather than a discrete financial, governance, or legal event, and does not fit the specific categories of earnings, M\u0026A, or other named types.","classifier_version":"claude-haiku-4-5-20251001+prompt-6be895f9","taxonomy_version":"v1.3","classified_at":"2026-09-08T10:09:41.930463+00:00","company_name":"BELITE BIO, INC","ticker":"BLTE","filing_date":"2026-09-08"}]}