Belite Bio NDA accepted for Stargardt disease drug

• Belite Bio (NASDAQ:BLTE) received FDA acceptance of its New Drug Application for tinlarebant with Priority Review for Stargardt disease type 1.
• The company reported Q2 2026 net loss of $28.4 million and ended the quarter with $279.9 million in cash and $500.1 million in investments.
• Belite completed enrollment in two late-stage trials as it prepares for a February 12, 2027 PDUFA target action date for tinlarebant.

Belite Bio (NASDAQ:BLTE) reported second-quarter 2026 results and announced that the U.S. Food and Drug Administration accepted its New Drug Application for tinlarebant with Priority Review for Stargardt disease type 1.

The FDA decision follows results from the Phase 3 DRAGON trial, where the company reported month-25 qAF levels were stable to slightly decreased by about 2% in tinlarebant-treated subjects compared with an approximate 20% increase in placebo subjects.

Belite also completed enrollment in the Phase 2/3 DRAGON II trial for Stargardt disease type 1 with 73 subjects and the Phase 3 PHOENIX trial for geographic atrophy with 530 subjects, while reporting second-quarter R&D expenses of $18.2 million and SG&A expenses of $16.7 million.

The FDA assigned a PDUFA target action date of February 12, 2027 for the tinlarebant NDA review, while Belite reported a second-quarter net loss of $28.4 million and non-GAAP net loss of $21.6 million.

Belite Bio is developing tinlarebant as a treatment candidate for retinal diseases, including Stargardt disease type 1 and geographic atrophy, through ongoing clinical programs.

As of June 30, 2026, Belite reported $279.9 million in cash and cash equivalents and $500.1 million in investments, providing funding as the company continues its regulatory and clinical development activities.