globenewswire.com · 12 jun

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

SAN DIEGO, June 12, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) ("Belite Bio" or the "Company"), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced the completion of its rolling submission of a New Drug Application (NDA) to the U.

globenewswire.com · 12 jun

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

SAN DIEGO, June 12, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio®” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced the completion of its rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tinlarebant. Tinlarebant is an investigational, once-daily oral therapy for the treatment of Stargardt disease type 1 (STGD1), a rare, inherited retinal disease caused by mutations in the ABCA4 gene that leads to progressive and irreversible vision loss. STGD1 affects an estimated 53,000 people in the U.S. alone, and there are currently no approved treatment options for the disease.

seekingalpha.com · 8 jun

Belite Bio, Inc (BLTE) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript

Belite Bio, Inc (BLTE) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript

globenewswire.com · 2 jun

Belite Bio to Participate in the Goldman Sachs 47th Annual Global Healthcare Conference

SAN DIEGO, June 02, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio®” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that the Company will participate in a fireside chat at the Goldman Sachs 47th Annual Global Healthcare Conference on Monday, June 8, 2026 at 4:00 pm ET. Webcast Link Instructions Webcasts of the presentations can be accessed under "Events" in the investor relations section of the Belite Bio website at: https://investors.belitebio.com/presentations-events/events.

seekingalpha.com · 20 may

Belite Bio, Inc (BLTE) Q1 2026 Earnings Call Transcript

Belite Bio, Inc (BLTE) Q1 2026 Earnings Call Transcript

marketbeat.com · 20 may

Belite Bio Q1 Earnings Call Highlights

Belite Bio NASDAQ: BLTE said it has begun a rolling New Drug Application submission to the U.S. Food and Drug Administration for Tinlarebant in Stargardt disease, while also accelerating preparations for a potential commercial launch.

globenewswire.com · 20 may

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

SAN DIEGO, May 20, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio®” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced its unaudited financial results for the first quarter ended March 31, 2026, and provided a business update.

globenewswire.com · 18 may

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

SAN DIEGO, May 18, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio®” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted tinlarebant, the Company's lead product candidate, orphan drug status (ODS) for the treatment of Stargardt disease (STGD1), a rare, inherited retinal disorder caused by mutations in the ABCA4 gene.