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Belite Bio, Inc. filings document foreign-issuer disclosures for a clinical-stage biopharmaceutical company developing tinlarebant for degenerative retinal diseases. Form 6-K reports furnish press releases on clinical-trial progress, FDA-related regulatory updates, financial results, annual-report availability, material agreements, shareholder matters, and capital-structure activity involving American Depositary Shares.
The company's Form 20-F reporting framework covers audited consolidated financial statements and public-company disclosure for BLTE as a foreign private issuer. Its filing record centers on STGD1, geographic atrophy in advanced dry AMD, tinlarebant development, financing activity, governance matters, and the incorporation of furnished reports into effective Securities Act registration statements.
BELITE BIO, INC (BLTE) disclosed that Chief Executive Officer and director Yu-Hsin Lin sold a total of 100,435 American depositary shares of the company in open‑market transactions on September 4 and September 8, 2026. The sales were executed under a Rule 10b5-1 trading plan adopted on December 23, 2025, at weighted average prices within disclosed ranges between $180 and $198.37 per share.
BELITE BIO, INC (BLTE) director and Chief Financial Officer Chuang Hao-Yuan reported open-market sales of 67,395 American depositary shares on September 4 and September 8, 2026. The ADSs were sold at weighted average prices across ranges from $180 to $198.335 per ADS, pursuant to a Rule 10b5-1 trading plan adopted on December 22, 2025.
BELITE BIO, INC (BLTE) announced that it has submitted a New Drug Application to Japan’s Ministry of Health, Labour, and Welfare for tinlarebant as a once-daily oral treatment for Stargardt disease type 1 (STGD1), under the Sakigake Designation System, an expedited review pathway for innovative drugs.
STGD1 is a rare inherited retinal disease with no approved treatments, affecting an estimated 9,500 people in Japan. Tinlarebant, Belite Bio’s lead candidate, has received multiple regulatory designations globally and is supported by a Phase 3 STGD1 trial that met its primary endpoint, with additional Phase 2/3 and Phase 3 trials ongoing in STGD1 and geographic atrophy.
BELITE BIO, INC director and Chief Financial Officer Hao-Yuan Chuang reported selling a total of 367 American depositary shares of the company on August 12, 2026, in two open-market transactions. Each sale was effected pursuant to a Rule 10b5-1 trading plan adopted on December 22, 2025.
BELITE BIO, INC director and Chief Executive Officer Lin Yu-Hsin reported selling a total of 365 American depositary shares of the company on 2026-08-12 in two open-market or private transactions at prices of $180.00 and $180.57 per share. Each American depositary share represents one ordinary share with a par value of US$0.0001. The sales were effected pursuant to a Rule 10b5-1 trading plan adopted on 12/23/2025.
Belite Bio reported unaudited results for the second quarter ended June 30, 2026 and highlighted major regulatory progress for its lead candidate tinlarebant. The U.S. FDA accepted the New Drug Application with Priority Review for treating Stargardt disease type 1, with a PDUFA target action date of February 12, 2027. The company also presented additional positive secondary endpoint data from its Phase 3 DRAGON trial.
Belite Bio is ramping launch preparations, including expanding its team and commercial infrastructure. As of June 30, 2026, it held $279.9 million in cash and cash equivalents and $500.1 million in U.S. treasury investments. For the quarter, GAAP R&D expenses were $18.2 million and SG&A expenses were $16.7 million, both higher than a year earlier as the company incurred milestone royalties, manufacturing costs, professional fees and personnel expenses. Total other income rose to $6.6 million, driven by interest income. Net loss for the quarter was $28.4 million, or $0.70 per share, and non-GAAP net loss was $21.6 million.
BLTE reports a planned sale of 126,800 American Depositary Shares, each representing one ordinary share, with the shares listed on NASDAQ and an outstanding class size of 39,339,960 ADS. The seller acquired these shares through multiple ESOP exercises and RSU vestings between February and November 2025.
BLTE filed a notice of proposed sale of American Depositary Shares, each representing one ordinary share, under a Form 144. The filing lists a potential sale of 93,800 ADS through J.P. Morgan Securities LLC. It also notes an earlier ESOP exercise involving 93,800 ADS for cash in March 2025.
Belite Bio reports that the U.S. FDA has accepted and granted Priority Review to its New Drug Application for tinlarebant to treat Stargardt Disease Type 1 (STGD1). The agency has set a PDUFA date of February 12, 2027, providing a clear timeline for a potential approval decision.
The NDA is supported by the Phase 3 DRAGON trial, where tinlarebant achieved a 35.7% reduction in the growth rate of atrophic retinal lesions versus placebo and was generally well tolerated. If approved, tinlarebant would become the first FDA-approved treatment for STGD1, which affects an estimated 53,000 people in the U.S. The drug also holds multiple regulatory designations, including Breakthrough Therapy, Fast Track, Rare Pediatric Disease, and Orphan Drug status in several regions.
Belite Bio Chief Medical Officer-linked entity sells ADSs. Bioptima Ltd., an entity associated with Chief Medical Officer Hendrik Peter Scholl, reported open-market sales totaling 10,000 American depositary shares of Belite Bio on June 18, 2026. The trades were executed in multiple blocks at prices ranging from about $143.90 to $147.11 per ADS, with some prices disclosed as weighted averages across narrower intraday ranges. Following these transactions, Bioptima Ltd. indirectly holds 15,000 American depositary shares of Belite Bio.