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 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.
Dr. Hendrick P. Scholl reported a disposition notice under Rule 144 describing a sale of 10,000 American Depositary Shares on 06/16/2026. The filing lists vested RSUs of 2,500 ADS (vested 10/17/2025) and 7,500 ADS (vested 11/03/2025) as compensation-related securities. The Form 144 was filed in connection with ADS trading on NASDAQ.
Belite Bio’s Chief Medical Officer, through affiliated entity Bioptima Ltd., reported net open-market sales of 10,000 American depositary shares (ADS) of BLTE on June 16. Each ADS represents one ordinary share. The sales occurred in multiple trades at prices ranging roughly from $137.19 to $145.60, based on weighted-average price disclosures. After these transactions, indirect holdings reported by Bioptima Ltd. stand at 32,946 ADS, indicating the CMO remains a significant indirect holder.
BLTE submitted a notice under Rule 144 proposing the sale of 10,000 American Depositary Shares (each representing one ordinary share). The shares are described as Vested RSUs with a vesting date of 10/17/2025. The filing date shown is 06/16/2026.
Belite Bio has completed its rolling New Drug Application submission to the U.S. FDA for tinlarebant, an investigational once-daily oral therapy for Stargardt disease type 1 (STGD1). STGD1 is a rare inherited retinal disease affecting an estimated 53,000 people in the U.S. with no approved treatments.
The NDA was submitted under Breakthrough Therapy Designation, reflecting the high unmet medical need. The FDA will conduct a 60-day review of the completed application, after which, if accepted, a PDUFA target action date will be assigned. Tinlarebant previously met the primary endpoint in the Phase 3 DRAGON trial by significantly reducing the growth rate of retinal lesions versus placebo.
Tinlarebant has multiple regulatory designations in the U.S., Europe, Japan, and Switzerland for STGD1, and is also being evaluated in trials for geographic atrophy in advanced dry age-related macular degeneration.