BLTE News & Events

As of March 31 the Company had $276.4M in cash and cash equivalents, compared with $352.9M on December 31, 2025. "This has been an exciting start to the year for Belite. In April, we announced the initiation of our rolling NDA submission to the FDA for tinlarebant in STGD1, an important step on our path to becoming a commercial company and potentially bringing the first ever treatment for this devastating disease to patients. We are on track to finalize the NDA submission in the second quarter," said Tom Lin, Chairman and CEO of Belite Bio. "Initiatives to advance our pre-commercial efforts, including hiring experienced commercial leaders and building out key teams within our organization, are underway. In tandem, we are taking a thoughtful approach to achieving our mission to make this potential treatment available to as many patients as possible worldwide."

Belite Bio announced that the Swiss Agency for Therapeutic Products has granted tinlarebant, the company's lead product candidate, orphan drug status for the treatment of Stargardt disease.

Belite Bio announced that it has initiated a rolling submission of a New Drug Application, NDA, to the U.S. Food and Drug Administration, FDA, for tinlarebant, an investigational novel oral therapy for the treatment of Stargardt disease type 1, a rare, inherited retinal disorder caused by mutations in the ABCA4 gene. Tinlarebant has previously been granted Breakthrough Therapy Designation by the FDA for STGD1, and the FDA has previously granted Belite approval for the rolling submission of the NDA. The Company expects to complete the NDA rolling submission in the second quarter of 2026.