Belite Bio, Inc American Depositary Shares BLTE

Belite Bio, Inc es una empresa de desarrollo de medicamentos biofarmacéuticos en fase clínica. La compañía se enfoca en terapias dirigidas a enfermedades oculares no tratables que involucran degeneración retiniana, como la degeneración macular relacionada con la edad atrófica (AMD seca) y la enfermedad de Stargardt autosómica recesiva (STGD1), ambas de las cuales conducen progresivamente a la ceguera permanente, y enfermedades metabólicas como la enfermedad del hígado graso no alcohólico (EHGNA), esteatohepatitis no alcohólica (EHNA), diabetes tipo 2 (T2D) y gota. La compañía está desarrollando LBS-008 como un tratamiento oral diario para STGD1 y AMD seca. LBS-008 es una terapia dirigida a AMD seca y STGD1, que son condiciones no tratables que causan pérdida progresiva de la visión en las personas afectadas. LBS-008 es un tratamiento oral una vez al día que puede reducir y mantener la entrega de vitamina A (retinol) al ojo. El LBS-009 de la compañía es una terapia oral anti-proteína de unión a retinol 4 (RBP4) que apunta a enfermedades hepáticas, incluyendo EHGNA, EHNA y T2D.

• GlobeNewswire Inc. 24 ago

  Belite Bio to Host Virtual Commercial Day on September 2, 2026

  Belite Bio announced that the FDA accepted and granted Priority Review designation for its New Drug Application for tinlarebant to treat Stargardt disease type 1 (STGD1), with a decision date set for February 12, 2027. The company will host a Virtual Commercial Day on September 2, 2026, to discuss the drug's commercial opportunity and prelaunch preparedness strategies.

  

• GlobeNewswire Inc. 6 jul

  Belite Bio to Participate in the Piper Sandler Virtual Ophthalmology Investor Symposium

  Belite Bio, a clinical-stage drug development company, announced it will participate in a fireside chat at the Piper Sandler Virtual Ophthalmology Investor Symposium on July 9, 2026. The company is advancing tinlarebant, an oral therapy for degenerative retinal diseases including Stargardt disease type 1 and geographic atrophy, with completed Phase 3 trials and ongoing Phase 2/3 and Phase 3 trials.

  

• GlobeNewswire Inc. 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

  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.