H.C. Wainwright reiterated a Buy rating and $200 price target on Belite Bio (NASDAQ:BLTE) following the company’s Q1 financial results and regulatory update. The stock currently trades at $143.36 with a market cap of $5.64 billion.
Belite Bio reported a net loss of $26.9 million ($0.68 per share) for Q1 of fiscal 2026. Despite ongoing losses typical for pre-revenue biotech firms, the company holds more cash than debt, with liquid assets exceeding short-term obligations.
The company initiated a rolling submission of a New Drug Application (NDA) to the U.S. FDA for tinlarebant as a treatment for Stargardt disease type 1 in April 2026. Management expects to complete the NDA submission in the current quarter.
Tinlarebant has received Breakthrough Therapy, Fast Track, Rare Pediatric Disease, and Orphan Drug designations from the FDA. The submission is based on 24-month results from the Phase 3 DRAGON trial in 104 adolescent STGD1 patients aged 12 to 20 years.
The company plans to deploy a sales team of approximately 30 personnel initially, focusing on genetic testing awareness to reach over 50,000 U.S. patients with ABCA4-mutated STGD1. Hiring of all key commercial leadership positions has been completed.
Tinlarebant recently received Orphan Drug status for STGD1 from the Swiss Agency for Therapeutic Products. H.C. Wainwright projects the drug could obtain FDA approval in Q1 2027.
