Belite Bio

10/08/2026

On World Sight Day, we join the global eye health community in recognizing the importance of protecting sight and continuing to advance research for people living with conditions that impact their vision. We’re also proud to share a new resource about Disease for physicians.

Learn more:

Discover resources to help patients navigate genetic retinal conditions that affect central vision

10/07/2026

Belite Bio is joining and leaders from across the retina community. We are also grateful to be recognized as Company of the Year and appreciate this recognition of the broader work underway to advance care for people living with degenerative retinal diseases.

Learn more: https://investors.belitebio.com/news-releases/news-release-details/belite-bio-announces-oral-presentations-two-upcoming-medical-2

10/01/2026

Belite Bio looks forward to participating in the Innovate Retina and American Academy of Ophthalmology (AAO) 2026 conferences this month. Learn more: https://investors.belitebio.com/news-releases/news-release-details/belite-bio-announces-oral-presentations-two-upcoming-medical-2

09/29/2026

Belite Bio is looking forward to connecting with the retina community at Euretina Innovation Spotlight (EIS) and Euretina in Vienna. We look forward to sharing more about our work in inherited retinal diseases including Stargardt disease. Learn more: https://investors.belitebio.com/news-releases/news-release-details/belite-bio-announces-oral-presentations-two-upcoming-medical-1

09/08/2026

Belite Bio announced the submission of a New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare for tinlarebant, an investigational, once-daily oral therapy for Stargardt disease type 1 (STGD1). The application was submitted under the Sakigake Designation System - Japan’s expedited regulatory pathway for innovative medical products. If approved, it could become the first Sakigake pharmaceutical product for ophthalmology disease in Japan.

This milestone follows the U.S. FDA’s acceptance of the tinlarebant NDA for Priority Review. We are grateful to the patients, families, investigators, and study sites who have supported the clinical development program.

Read more: https://investors.belitebio.com/news-releases/news-release-details/belite-bio-announces-submission-new-drug-application-ministry

09/03/2026

Belite Bio announced the Company will participate in fireside chats at four investor conferences this September:

• Wells Fargo 21st Annual Healthcare Conference, Sept. 8
• 2026 Cantor Global Healthcare Conference, Sept. 11
• Morgan Stanley 24th Annual Global Healthcare Conference, Sept. 14
• H.C. Wainwright 28th Annual Global Investment Conference, Sept. 15

Learn more: https://investors.belitebio.com/news-releases/news-release-details/belite-bio-participate-four-upcoming-investor-conferences-1

08/25/2026

Join us September 2 at 8:00 a.m. ET for Belite Bio’s Virtual Commercial Day, featuring perspectives on Stargardt disease type 1 (STGD1), the current treatment landscape and market opportunity, and the Company’s commercialization priorities for tinlarebant, if approved by the FDA. Register: https://investors.belitebio.com/news-releases/news-release-details/belite-bio-host-virtual-commercial-day-september-2-2026

08/12/2026

Belite Bio is proud to announce the U.S. Food and Drug Administration has accepted our New Drug Application (NDA) for tinlarebant in Stargardt disease type 1 and granted Priority Review. The Prescription Drug User Fee Act (PDUFA) target action date is February 12, 2027. Stargardt disease is a condition with significant unmet needs, and we are encouraged by the potential to bring the first approved therapy to patients in the U.S.

Learn more: https://investors.belitebio.com/news-releases/news-release-details/belite-bio-announces-us-food-and-drug-administration-acceptance

07/14/2026

Belite Bio is proud to sponsor this year’s American Society of Retina Specialists (ASRS) Annual Meeting, taking place July 15-18.

If you’re attending ASRS, visit the Belite team at Booth #1118 to learn more.

07/10/2026

Belite Bio announced that data from the DRAGON clinical trial will be presented at the 63rd Annual Symposium of the International Society for Clinical Electrophysiology of Vision (ISCEV) being held on July 6-11, 2026, in Sydney, Australia, and the American Society of Retina Specialists (ASRS) 2026 Annual Meeting being held on July 15-18, 2026, in Montréal, Canada.

Learn more: https://investors.belitebio.com/news-releases/news-release-details/belite-bio-announces-oral-presentations-two-upcoming-medical