Belite Bio Inc's stock surged by 12.78%, reaching a 52-week high following the announcement of significant Phase 3 trial results for Tinlarebant. The trial demonstrated a 36% reduction in lesion growth in patients with Stargardt disease, indicating a major advancement in treatment options.
The company plans to file a New Drug Application with the US FDA in the first half of 2026, supported by Breakthrough Therapy and Fast Track designations. This positions Tinlarebant as a potential first-line treatment for over 50,000 patients in the U.S., enhancing the company's market outlook.
The positive trial results not only boost investor confidence but also highlight Belite Bio's commitment to addressing unmet medical needs in retinal degenerative diseases, potentially leading to increased market share and revenue growth.
Wall Street analysts forecast BLTE stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for BLTE is 170.86 USD with a low forecast of 85.00 USD and a high forecast of 200.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
7 Analyst Rating
Wall Street analysts forecast BLTE stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for BLTE is 170.86 USD with a low forecast of 85.00 USD and a high forecast of 200.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
7 Buy
0 Hold
0 Sell
Strong Buy
Current: 165.640
Low
85.00
Averages
170.86
High
200.00
Current: 165.640
Low
85.00
Averages
170.86
High
200.00
BofA
Tazeen Ahmad
Buy
initiated
$195
2026-01-26
New
Reason
BofA
Tazeen Ahmad
Price Target
$195
AI Analysis
2026-01-26
New
initiated
Buy
Reason
BofA analyst Tazeen Ahmad initiated coverage of Belite Bio with a Buy rating and $195 price target. Tinlarebant is an oral, once-daily RPB4 antagonist that has produced positive Phase 3 results with the potential to be the first-approved therapy for Stargardt disease type 1, the analyst tells investors. The firm thinks tinlarebant for STGD1 represents "a significant commercial opportunity given the high unmet need," the analyst tells investors.
Morgan Stanley
Overweight
initiated
$191
2026-01-06
Reason
Morgan Stanley
Price Target
$191
2026-01-06
initiated
Overweight
Reason
Morgan Stanley initiated coverage of Belite Bio with an Overweight rating and $191 price target. The firm says its key opinion leader checks support a multi-billion dollar opportunity for tinlarebant in Stargardt disease type 1. Potential regulatory approval and commercial launch are catalysts to move shares higher over the next 12 months, the analyst tells investors in a research note.
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Maxim
NULL -> Buy
maintain
$140 -> $200
2025-12-02
Reason
Maxim
Price Target
$140 -> $200
2025-12-02
maintain
NULL -> Buy
Reason
Maxim raised the firm's price target on Belite Bio to $200 from $140 and keeps a Buy rating on the shares after the company reported positive topline results from the Phase 3 DRAGON trial of tinlarebant in adolescent Stargardt disease.
Mizuho
Graig Suvannavejh
Neutral -> Outperform
upgrade
$194
2025-12-02
Reason
Mizuho
Graig Suvannavejh
Price Target
$194
2025-12-02
upgrade
Neutral -> Outperform
Reason
Mizuho analyst Graig Suvannavejh upgraded Belite Bio to Outperform from Neutral with a $194 price target.
About BLTE
Belite Bio, Inc is a clinical-stage biopharmaceutical drug development company. The Company is focused on advancing novel therapeutics targeting retinal degenerative eye disease, such as Geographic Atrophy (GA), age-related macular degeneration (AMD), and Stargardt disease type 1 (STGD1), both of which progressively lead to permanent blindness, and metabolic diseases such as non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), type 2 diabetes (T2D), and gout. Its lead product candidate, Tinlarebant, is an oral daily treatment for STGD1 and GA patients. In STGD1, it is developing Tinlarebant as a once-a-day tablet treatment to target Retinol binding protein 4 (RBP4) by disrupting vitamin A (retinol) binding to RBP4, which leads to reduced delivery of retinol to the eye and reduced accumulation of toxic vitamin A by-products. Its product candidate also includes LBS-009, an anti-RBP4 oral therapy targeting liver disease, including NAFLD, NASH, and T2D.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
