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 announced the completion of its rolling NDA submission to the FDA for tinlarebant, an oral therapy for Stargardt disease type 1 (STGD1), a rare inherited retinal disease affecting approximately 53,000 people in the U.S. with no current approved treatments. The submission was made under Breakthrough Therapy Designation and will undergo a 60-day FDA review period. The Phase 3 DRAGON trial demonstrated tinlarebant's ability to significantly reduce the growth rate of retinal lesions compared to placebo.

06/12/2026, 9:30 PM • GlobeNewswire

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

Belite Bio initiated a rolling NDA submission to the FDA for tinlarebant to treat Stargardt disease type 1 (STGD1), with completion expected in Q2 2026. The company reported Q1 2026 results showing $798.6 million in cash and investments, increased R&D and SG&A expenses due to commercialization preparation and team expansion, and a net loss of $26.9 million (GAAP). Key commercial leadership positions have been hired as the company prepares for potential market launch.

05/20/2026, 6:00 AM • GlobeNewswire

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

Belite Bio announced that tinlarebant, its lead product candidate for Stargardt disease, has received orphan drug status from Switzerland's Swissmedic. The drug previously demonstrated a 35.7% reduction in retinal lesion growth rate in the Phase 3 DRAGON trial and has received multiple regulatory designations including Breakthrough Therapy and Fast Track designations in the U.S. The company is rolling out an NDA submission with the FDA expected to complete in Q2 2026.

05/18/2026, 4:00 PM • GlobeNewswire

Belite Bio to Host Webcast on May 20, 2026, to Discuss First Quarter 2026 Financial Results

Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage biopharmaceutical company developing therapeutics for degenerative retinal diseases, announced a webcast scheduled for May 20, 2026, at 4:30 p.m. ET to discuss Q1 2026 financial results and provide a business update. The company's lead candidate, tinlarebant, is being evaluated in Phase 2/3 and Phase 3 trials for Stargardt disease type 1 and geographic atrophy.

05/13/2026, 4:00 PM • GlobeNewswire

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 (NDA) to the FDA for tinlarebant, an oral therapy for treating Stargardt disease type 1 (STGD1). The drug has received Breakthrough Therapy Designation and could become the first approved treatment for this rare inherited retinal disorder. The company expects to complete the NDA submission in Q2 2026 and is preparing for potential commercialization in 2027.

04/21/2026, 4:00 PM • GlobeNewswire

Belite Bio Announces Pricing of $350.0 Million Underwritten Public Offering of American Depositary Shares

Belite Bio has priced a public offering of 2,272,727 American Depositary Shares at $154.00 per share, expecting to raise approximately $350 million to fund commercialization preparation, pipeline development, and general corporate purposes.

12/01/2025, 10:37 PM • GlobeNewswire

Geographic Atrophy Market to Surge Significantly During the Forecast Period (2025–2034) Due to Rising Adoption of Complement Inhibitor Therapies | DelveInsight

The geographic atrophy market is expected to grow significantly due to rising global prevalence, aging populations, and emerging therapies targeting this advanced form of age-related macular degeneration.

12/01/2025, 1:00 PM • GlobeNewswire

Dry Age-related Macular Degeneration Market Poised for Rapid Growth During the Forecast Period (2025–2034) Amid Expanding Treatment Landscape | DelveInsight

The dry AMD market is expected to grow significantly by 2034, driven by emerging therapies, increasing diagnosis rates, and novel treatment approaches targeting geographic atrophy.

11/17/2025, 1:00 PM • GlobeNewswire

Belite Bio Announces UK’s Medicines and Healthcare Products Regulatory Agency Agrees to Conditional Marketing Authorization Application Based on Interim Analysis Results for the Treatment of Stargardt Disease with Tinlarebant

Belite Bio received conditional marketing authorization from the UK's MHRA for Tinlarebant, a potential treatment for Stargardt disease, based on interim Phase 3 DRAGON trial results. The company expects final topline data in Q4 2025.

11/02/2025, 9:00 AM • GlobeNewswire

Belite Bio Announces China NMPA Agrees to New Drug Application with Priority Review based on Interim Analysis Results for the Treatment of Stargardt Disease with Tinlarebant

Belite Bio received priority review from China's NMPA for Tinlarebant, a novel oral therapy for treating Stargardt disease, based on positive interim Phase 3 trial results. The company expects final topline data in Q4 2025.

10/15/2025, 8:00 AM • GlobeNewswire

3 Lesser-Known Healthcare Names With Major Upside in Store

The global healthcare market is expected to grow significantly, with three lesser-known companies showing promising potential: Sanuwave Health, Amneal Pharmaceuticals, and Belite Bio, each offering unique strengths in medical technology and pharmaceuticals.

10/02/2025, 9:06 AM • Investing

Belite Bio Announces Up to $275 Million Upsized Private Placement Financing by Leading Healthcare Investors

Belite Bio secured a $125 million private placement financing led by RA Capital Management, with potential for an additional $150 million through warrant exercises, to support its clinical-stage drug development for retinal degenerative diseases.

09/08/2025, 8:00 AM • GlobeNewswire

Belite Bio Announces Registered Direct Offering of $15 Million

Belite Bio has entered into a securities purchase agreement to sell 230,770 American Depositary Shares and accompanying warrants at $65 per share, expecting to raise approximately $15 million for working capital and general corporate purposes.

08/07/2025, 8:00 AM • GlobeNewswire

Belite Bio Announces Completion of Enrollment in the Pivotal Global Phase 3 PHOENIX Trial Evaluating Oral Tinlarebant in Geographic Atrophy

Belite Bio completed enrollment in a global Phase 3 trial evaluating Tinlarebant, an oral medication for treating geographic atrophy in dry age-related macular degeneration, with 500 subjects across 8 countries.

07/02/2025, 3:00 AM • GlobeNewswire