Belite Bio Inc. ADR

Belite Bio reported adjusted EPS of -$0.54 for Q2 2026, beating the consensus estimate of -$0.7525. The company has no product revenue yet; R&D and SG&A expenses rose significantly, while cash and cash equivalents amounted to $780 million. The FDA accepted the NDA for Tinlarebant for priority review and set a PDUFA date of February 12, 2027. The stock fell 7.08% in regular trading and recovered slightly after hours. » Más en de.investing.com

Belite Bio presented data from the Tinlarebant DRAGON study at a scientific conference showing a 35.7% reduction in the annualized growth of macular lesions and reporting an overall manageable safety profile. Clinicians emphasized that structural benefits will require longer follow‑up before clear functional improvements in visual acuity appear. Belite has submitted the NDA, is awaiting the FDA Day‑74 letter, and is seeking accelerated pathways in the US and Japan; commercial uptake will depend on diagnosis rates, reimbursement, and longer confirmatory data. » Más en de.investing.com

Belite Bio reports that the phase‑3 DRAGON study of tinlarebant showed a 37% reduction in progression of decreased‑autofluorescence lesions and reinforces an ongoing New Drug Application (NDA) process at the FDA. The company highlights its already granted Breakthrough Therapy designation and an expected accelerated review. Safety data are described as manageable; mostly mild, reversible visual adjustment effects occurred and there were no serious treatment‑related ocular events. The confirmatory DRAGON II study is fully recruited (73 patients) and is intended to support approvals in additional markets; tinlarebant is positioned as a once‑daily oral, first‑in‑class therapy for Stargardt. » Más en de.investing.com