BofA Securities has initiated coverage of Belite Bio, Inc. ADR (NASDAQ: BLTE) with a Buy rating and set a price target of $195.00. The target equates to an approximately 18% potential upside relative to the most recent quoted price of $164.58. The stock is trading near a 52-week high of $170.25 after a 177% rally over the past year.
The bank’s analysis centers on tinlarebant, an oral, once-daily RPB4 antagonist that the firm sees as a potential first approved therapy for Stargardt disease type 1 (STGD1) - a rare, inherited condition that causes vision loss in children. Belite Bio has a market capitalization of $6.17 billion and remains unprofitable.
Tinlarebant has produced positive Phase 3 results, and Belite Bio is preparing regulatory submissions. BofA notes a planned filing with the U.S. Food and Drug Administration in the first half of 2026, with additional submissions targeted for the United Kingdom, European Union, Japan and China in the second half of 2026.
The drug is being evaluated across multiple clinical programs: the phase 1b/2/3 DRAGON II study for STGD1 and the phase 3 PHOENIX trial for geographic atrophy (GA), another retinal disorder. In its commentary, BofA described tinlarebant for STGD1 as "a significant commercial opportunity given the high unmet need" in that patient population.
Alongside the coverage initiation, Belite Bio disclosed the pricing of a public offering of 2,272,727 American Depositary Shares at $154 apiece, with gross proceeds expected to be about $350 million. The company also reported positive results from its Phase 3 DRAGON trial for tinlarebant, which met its primary efficacy endpoint.
Investor and analyst activity has accelerated following the DRAGON data. Mizuho upgraded its rating on Belite Bio from Neutral to Outperform and lifted its price target to $194 from $105, citing the trial’s efficacy and safety. Benchmark raised its price target to $187 from $132 while maintaining a Buy rating. Cantor Fitzgerald reiterated an Overweight rating and highlighted the company’s preparations for a commercial launch of tinlarebant. Morgan Stanley initiated coverage with an Overweight rating and set a $191 price target, reflecting optimism tied to the Phase 3 outcomes.
Together, these broker moves underscore a market narrative focused squarely on the commercial prospects for tinlarebant in STGD1 and the broader potential in retinal diseases, while the firm’s recent capital raise provides near-term liquidity to support regulatory and launch activities.
Summary
BofA has begun coverage of Belite Bio with a Buy rating and a $195 target, highlighting tinlarebant’s potential as a first-in-class therapy for STGD1 after positive Phase 3 results. The company has also priced a sizeable public offering and received multiple analyst upgrades that emphasize expectations for commercial upside.
Key points
- BofA initiates coverage with a Buy rating and $195 price target, ~18% above the $164.58 share price.
- Tinlarebant is an oral, once-daily RPB4 antagonist with positive Phase 3 data and planned regulatory filings in 2026.
- Belite priced 2,272,727 ADS at $154 each for estimated gross proceeds of roughly $350 million; multiple brokers have raised ratings or price targets following the DRAGON results.
Risks and uncertainties
- Regulatory timing and outcomes remain uncertain - filings are planned for 2026 but approvals are not guaranteed, affecting the healthcare and biotech sectors.
- Belite is not yet profitable, which bears on financial and capital markets risk as the company deploys proceeds toward regulatory and commercial preparations.
- The public offering could affect share count and investor returns; market reception of the offering and subsequent dilution are potential uncertainties for equity holders.
The market will be watching both the regulatory submission timeline and execution on commercial readiness as Belite advances tinlarebant toward potential approval and launch.