Belite Bio, Inc

Belite Bio Announces Uplisting to the Nasdaq Global Select Market

Belite Bio received Nasdaq approval to transfer its listing from the Nasdaq Capital Market to the Nasdaq Global Select Market, effective at the open on October 19, 2026, under the existing ticker BLTE. The Global Select Market is Nasdaq's highest tier with more stringent financial and liquidity standards, and the company expects the move to enhance institutional visibility, improve liquidity, and broaden market recognition. Belite Bio remains a clinical-stage company focused on degenerative retinal diseases; its lead candidate tinlarebant has met the primary endpoint in a Phase 3 Stargardt trial (DRAGON) and is in further Phase 2/3 and Phase 3 trials.

•13d ago

Belite Bio Announces Multi-Market Submission of Marketing Authorization Applications Via the Access Consortium Pathway for Tinlarebant for the Treatment of Stargardt Disease Type 1

Belite Bio submitted Marketing Authorization Applications for tinlarebant in Stargardt disease type 1 to regulators in Singapore, the UK, and Switzerland via the Access Consortium pathway. The filings run in parallel with accepted NDAs in the US (Priority Review, PDUFA target action date February 12, 2027) and Japan under the SAKIGAKE designation. If approved, tinlarebant would be the first-ever approved treatment for STGD1 in these three countries, broadening the drug's potential global footprint.

•18d ago

Belite Bio Announces Oral Presentations at Two Upcoming Medical Conferences

Belite Bio will present data at the Euretina Innovation Spotlight on September 30, 2026, and at Euretina in Vienna, Austria, October 1-4, 2026. The Euretina session features topline results from the Phase 3 DRAGON study of tinlarebant in adolescent Stargardt disease, presented by Michel Michaelides of Moorfields Eye Hospital. Tinlarebant's NDA for Stargardt disease type 1 is under FDA priority review with a PDUFA date of February 12, 2027; DRAGON already met its primary endpoint.

•1mo ago

Belite Bio Announces Submission of New Drug Application to the Ministry of Health, Labour, and Welfare in Japan under the Sakigake Designation System for Tinlarebant for the Treatment of Stargardt Disease Type 1

Belite Bio has submitted a New Drug Application to Japan's Ministry of Health, Labour, and Welfare for tinlarebant in Stargardt disease type 1, with the application reviewed under Japan's expedited Sakigake Designation System. The Japanese filing was made side-by-side with the U.S. NDA, which the FDA has accepted with Priority Review and a PDUFA target action date of February 12, 2027. If approved, tinlarebant would be the first-ever approved treatment for STGD1 — a rare inherited retinal disease affecting an estimated 9,500 people in Japan with no current treatment options — and could become the first Sakigake-designated ophthalmology product in Japan. The filing is backed by the completed Phase 3 DRAGON trial, which met its primary endpoint by slowing retinal lesion growth, while Phase 3 (PHOENIX) testing in geographic atrophy continues.

•1mo ago

Belite Bio Reports Unaudited Second Quarter 2026 Financial Results and Provides a Corporate Update

The FDA accepted the New Drug Application (NDA) for tinlarebant for the treatment of Stargardt disease type 1 (STGD1) with Priority Review, assigning a PDUFA target action date of February 12, 2027. The company also presented positive secondary endpoint data from the Phase 3 DRAGON trial, showing a marked divergence in quantitative autofluorescence between treatment and placebo groups. Belite reported a strong balance sheet with $279.9 million in cash and $500.1 million in investments as of June 30, 2026, totaling approximately $780 million in liquidity. For the second quarter of 2026, the company reported a net loss of $28.4 million, driven by increased R&D expenses due to a milestone royalty payment and higher SG&A costs for commercialization preparations. Enrollment is complete in both the DRAGON II trial for STGD1 and the PHOENIX trial for Geographic Atrophy, positioning the company for multiple near-term data readouts and potential future regulatory submissions.

•2mo ago

Belite Bio Announces U.S. Food and Drug Administration Acceptance and Priority Review of New Drug Application for Tinlarebant for the Treatment of Stargardt Disease Type 1

Belite Bio announced that the FDA has accepted and granted Priority Review to its New Drug Application for tinlarebant for the treatment of Stargardt Disease Type 1, with a target PDUFA action date of February 12, 2027. The submission is supported by data from the Phase 3 DRAGON trial, which demonstrated a statistically significant and clinically meaningful 35.7% reduction in the growth rate of atrophic retinal lesions compared to placebo. If approved, tinlarebant would be the first-ever FDA-approved treatment option for STGD1, a rare inherited retinal disease affecting an estimated 53,000 people in the U.S.

•2mo ago

Belite Bio Announces Oral Presentation at the ASRS Annual Meeting Featuring Additional Positive Secondary Endpoint Data from the Phase 3 Trial of Tinlarebant in Stargardt Disease Type 1

Belite Bio presented additional positive secondary endpoint data from the Phase 3 DRAGON trial of tinlarebant for Stargardt disease at the ASRS Annual Meeting. The data showed quantitative autofluorescence remained stable to slightly decreased in the treatment group at month 25, compared to an approximate 20% increase in the placebo group. The presentation reinforced the previously announced primary endpoint success, where tinlarebant achieved a statistically significant 35.7% reduction in the growth rate of retinal lesions. The company also confirmed that its New Drug Application to the FDA has been completed. Management highlighted that the marked divergence in treatment groups strengthens the conviction in tinlarebant's potential to become the first therapy approved for Stargardt disease type 1.

•3mo ago

Belite Bio Announces Oral Presentations at Two Upcoming Medical Conferences

Belite Bio announced that data on its lead candidate Tinlarebant will be presented at the ISCEV Annual Symposium in Sydney and the ASRS Annual Meeting in Montréal. Professor John Grigg will present topline results from the Phase 3 DRAGON study in adolescent Stargardt’s Disease on July 8, while Dr. Paul Bernstein will present Phase 3 DRAGON trial results on July 18. Tinlarebant is an oral therapy designed to reduce bisretinoid accumulation and holds Breakthrough Therapy, Fast Track, and Orphan Drug designations in the U.S.

•3mo ago

Belite Bio Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt Disease Type 1

Belite Bio completed the rolling submission of its New Drug Application (NDA) to the FDA for tinlarebant, an oral therapy for Stargardt disease type 1. The submission was initiated in April 2026 under Breakthrough Therapy Designation and is now subject to a 60-day FDA review period, after which a PDUFA target action date will be assigned if accepted. Tinlarebant targets a rare inherited retinal disease affecting an estimated 53,000 people in the U.S., for which there are currently no approved treatment options.

•4mo ago

Belite Bio Receives Orphan Drug Status for Tinlarebant in Stargardt Disease in Switzerland

Belite Bio announced that Swissmedic has granted orphan drug status to tinlarebant for the treatment of Stargardt disease. This designation follows the successful Phase 3 DRAGON trial, which showed a 35.7% reduction in retinal lesion growth rate compared to placebo. The company is currently completing a rolling New Drug Application submission with the FDA, expected to finish in the second quarter of 2026.

•5mo ago

Belite Bio Announces Oral Presentation at the 27th Fundus Disease Forum and International Retinal Symposium (Retina China 2026)

Belite Bio will present oral topline results from its Phase 3 DRAGON trial of tinlarebant for Stargardt disease type 1 at the Retina China 2026 symposium in Nanjing. The presentation, led by Dr. Ruifang Sui, highlights a 35.7% reduction in the growth rate of atrophic retinal lesions compared to placebo, with a favorable safety profile. This follows the company's April 2026 initiation of a rolling NDA submission to the FDA, reinforcing the clinical validation of its lead asset ahead of potential regulatory review.

•5mo ago

Belite Bio to Present at the Deutsche Bank American Depositary Receipt Virtual Investor Conference on April 28th

Belite Bio announced that Chief Medical Officer Dr. Hendrick Scholl will present at the Deutsche Bank ADR Virtual Investor Conference on April 28. The company highlighted the recent initiation of a rolling NDA submission for tinlarebant in Stargardt disease, following Phase 3 data showing a 35.7% reduction in lesion growth. Belite also noted the completion of a $402 million public offering to fund commercialization and the finalization of enrollment in the DRAGON II trial.

•6mo ago

Belite Bio Initiates Rolling Submission of New Drug Application to the U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt Disease

Belite Bio has initiated a rolling submission of a New Drug Application to the FDA for tinlarebant as a treatment for Stargardt disease type 1, with completion expected in the second quarter of 2026. The submission utilizes the Breakthrough Therapy Designation and includes transformative data from the Phase 3 DRAGON trial. Management is actively preparing for a potential commercial launch next year by expanding teams in sales, market access, and medical affairs.

•6mo ago