Belite Bio posts Q2 2026 results as FDA reviews tinlarebant NDA under priority review
The FDA accepted Belite Bio's NDA for tinlarebant in Stargardt disease type 1 with a PDUFA date of February 12, 2027, as the company reported wider losses and new Phase 3 data.
Belite Bio, Inc reported unaudited second quarter 2026 financial results on August 12, 2026, alongside a corporate update. The FDA had accepted the NDA submission and granted Priority Review, with an assigned PDUFA target action date of February 12, 2027.1
In a separate release on August 11, 2026, the company said the filing was based on results from the Phase 3 DRAGON trial, in which tinlarebant showed a 35.7% reduction in the growth rate of atrophic retinal lesions, measured as definitely decreased autofluorescence by fundus autofluorescence imaging, compared with placebo2, calling the result statistically significant and clinically meaningful. The company said if approved, tinlarebant would be the first ever FDA-approved treatment option for STGD1, a disease caused by mutations in the ABCA4 gene that leads to progressive and irreversible vision loss and that affects an estimated 53,000 people in the U.S.2
Belite Bio also presented additional data at the ASRS 2026 Annual Meeting, reporting that at month 25, qAF values in tinlarebant-treated subjects remained stable to slightly decreased from baseline (approximately 2%), whereas placebo-treated subjects showed an approximate 20% increase from baseline1.
On the pipeline side, the DRAGON II trial completed enrollment with 73 subjects, including 15 Japanese subjects for the Phase 2/3 trial in STGD11, and the PHOENIX trial in geographic atrophy completed enrollment with 530 subjects1.
Financially, the company had $279.9 million in cash and cash equivalents as of June 30, 2026, compared with $352.9 million on December 31, 20251, and $500.1 million in U.S. treasury bills and U.S. treasury notes, compared to $419.7 million as of December 31, 20251. Net loss for the three months ended June 30, 2026 came to $28.4 million versus $16.3 million a year earlier, and for the six months it was $55.4 million versus $30.6 million.1 R&D expenses for the quarter rose to $18.2 million from $11.0 million, mainly due to a royalty payment tied to a license milestone.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.