H.C. Wainwright reiterated its Buy rating on Belite Bio, Inc. ADR (NASDAQ: BLTE) and left its price target at $185.00 after the company said the Phase 2/3 portion of its DRAGON II clinical trial had finished enrolling adolescent subjects. The stock is trading at $167.34, reflects a 183% gain over the past year and is close to its 52-week high of $174.78.
Belite reported that the Phase 2/3 segment of DRAGON II has enrolled 60 subjects aged 12 to 20 years across sites in Japan, the United States and the United Kingdom, including 15 participants in Japan. The multinational cohort is intended to support evaluation of tinlarebant for Stargardt disease type 1 (STGD1).
The Phase 2/3 portion is structured as a multicenter, double-masked, placebo-controlled, randomized study with a 1:1 allocation. The trial will assess the efficacy, safety and tolerability of once-daily oral tinlarebant administered for 24 months in patients with STGD1.
Belite said that data generated by the DRAGON program, together with outcomes from Japanese patients enrolled in DRAGON II, could form the basis for a regulatory submission to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). In Japan, tinlarebant has received both Orphan Drug and Sakigake designations, designations that may accelerate the drug’s regulatory pathway in that market.
Market data shows Belite’s shares often move independently of broader market trends, with a reported beta of -1.46. The company’s stock performance and the clinical readouts appear to be attracting analyst attention and fresh coverage.
In recent analyst moves, BofA Securities initiated coverage on Belite Bio with a Buy rating, underlining the potential for tinlarebant as a treatment for STGD1. Cantor Fitzgerald reaffirmed an Overweight rating and pointed to the company’s preparations for a potential launch, including hiring a Chief Commercial Officer and building a commercial team. Morgan Stanley also initiated coverage with an Overweight rating and set a $191 price target, citing positive results from the Phase 3 DRAGON study. Benchmark increased its price target to $187 from $132 and maintained a Buy rating after the drug reportedly met the primary efficacy endpoint in the trial.
Taken together, the clinical enrollment milestone in DRAGON II and the cluster of analyst actions - which include new coverage and target revisions - illustrate growing confidence among sell-side firms in Belite’s development program for tinlarebant. The company now has both clinical momentum and early commercial planning in motion as it advances through pivotal development stages.
Investors should note the interplay of several factors highlighted by the company and analysts: the cross-border enrollment in DRAGON II, the randomized, double-masked design of the Phase 2/3 study, the potential regulatory pathway in Japan informed by both DRAGON and DRAGON II data, and the regulatory designations awarded to tinlarebant in Japan.
This combination of clinical progress, analyst support and preparatory commercial hires provides a framework for understanding current market sentiment toward Belite Bio, even as the company continues to generate and consolidate the data that would underpin any future regulatory submission and potential launch planning.
Note: The article presents the company and analyst information as reported. It does not include additional commentary beyond the facts provided about trial enrollment, study design, regulatory designations and analyst ratings and price targets.