BELITE BIO, INC

Belite Bio, Inc. announced it will host a webcast on Thursday, August 13, 2026, to discuss its financial results and provide a business update for the second quarter ended June 30, 2026. The webcast is scheduled for 4:30 p.m. Eastern Time and will be accessible via a provided link on the company's investor relations website. A replay of the event will be available for approximately 90 days.

Belite Bio announced the completion of its New Drug Application (NDA) to the U.S. FDA for tinlarebant, a treatment for Stargardt disease type 1 (STGD1). The company also reported additional positive secondary endpoint data from its Phase 3 DRAGON trial, presented at the ASRS 2026 Annual Meeting. Quantitative autofluorescence (qAF) showed a marked divergence, with treated subjects' qAF remaining stable or slightly decreasing, while placebo subjects experienced an approximate 20% increase. This reinforces the previously announced primary endpoint success, which demonstrated a 35.7% reduction in retinal lesion growth.

Belite Bio, Inc. announced its participation in a fireside chat at the Piper Sandler Virtual Ophthalmology Investor Symposium. The event is scheduled for July 9, 2026, at 12:30 pm ET, and a webcast will be available on the company's investor relations website. Belite Bio is a clinical-stage drug development company focused on degenerative retinal diseases, with its lead candidate tinlarebant in Phase 2/3 and Phase 3 trials.

Belite Bio, Inc. announced it will present topline results from its Phase 3 DRAGON study of Tinlarebant for adolescent Stargardt’s Disease at two major scientific symposia in July 2026. The presentations will occur at the 63rd Annual Symposium of the International Society for Clinical Electrophysiology of Vision (ISCEV) in Sydney, Australia, and the American Society of Retina Specialists (ASRS) 2026 Annual Meeting in Montréal, Canada. Tinlarebant, an oral therapy for degenerative retinal diseases, has previously received multiple designations including Breakthrough Therapy and Orphan Drug.

Belite Bio, Inc. announced the completion of its rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for tinlarebant. This investigational, once-daily oral therapy targets Stargardt disease type 1 (STGD1), a rare inherited retinal disease affecting approximately 53,000 people in the U.S. with no approved treatments. The NDA, submitted under Breakthrough Therapy Designation, will now undergo a 60-day FDA review, with a PDUFA target action date to be assigned if accepted. The company is also preparing for commercial launch following potential approval.

Belite Bio announced the initiation of a rolling New Drug Application (NDA) submission to the U.S. FDA for tinlarebant for Stargardt disease type 1 (STGD1) in April 2026, with completion anticipated in the second quarter of 2026. The company is also advancing commercialization preparations for STGD1, having completed hiring for key leadership positions. For the first quarter ended March 31, 2026, Belite Bio reported a GAAP net loss of $26.9 million, an increase from $14.3 million in the prior year, driven by higher R&D and SG&A expenses. The company maintained a strong cash position with $798.6 million in cash and investments.

Belite Bio announced that Swissmedic granted orphan drug status to tinlarebant for Stargardt disease (STGD1), a rare inherited retinal disorder with no approved treatments. This follows positive Phase 3 DRAGON trial results, where tinlarebant showed a 35.7% reduction in retinal lesion growth. The company has also initiated a rolling NDA submission with the U.S. FDA, expected to complete in Q2 2026, and tinlarebant holds multiple other designations globally.

Belite Bio, Inc., a clinical-stage biopharmaceutical company, announced it will host a webcast on Wednesday, May 20, 2026, at 4:30 p.m. Eastern Time. The webcast will discuss the company's financial results and provide a business update for the first quarter ended March 31, 2026. A replay of the event will be available for approximately 90 days.

Belite Bio has initiated a rolling New Drug Application (NDA) submission to the U.S. FDA for tinlarebant, its investigational oral therapy for Stargardt disease type 1 (STGD1). The company anticipates completing the submission in the second quarter of 2026. This significant milestone leverages tinlarebant's Breakthrough Therapy Designation and positions it as a potential first-ever approved treatment for this rare, progressive retinal disorder, impacting patients and caregivers.