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Belite Bio Inc. (NASDAQ: BLTE) Stock Upgrade and Phase 3 DRAGON Trial Success

  • H.C. Wainwright upgraded Belite Bio Inc. (NASDAQ: BLTE) to "Buy" and increased its price target from $98 to $185.
  • The successful Phase 3 DRAGON trial for Tinlarebant in treating Stargardt disease type 1 (STGD1) demonstrated a 36% reduction in lesion growth compared to placebo.
  • Belite Bio plans to file a New Drug Application (NDA) with the FDA in the first half of 2026, aiming for commercialization.

Belite Bio Inc. (NASDAQ: BLTE) is a biopharmaceutical company focused on developing treatments for eye diseases. Recently, H.C. Wainwright upgraded BLTE's stock to "Buy" and increased its price target from $98 to $185. At the time of this announcement, the stock was priced at approximately $148.17, reflecting positive market sentiment.

The upgrade coincides with Belite Bio's successful Phase 3 DRAGON trial for Tinlarebant, a drug targeting Stargardt disease type 1 (STGD1). This trial is a significant milestone, as it is the first successful pivotal trial for STGD1, a rare eye disease causing progressive vision loss. The trial enrolled 104 patients and demonstrated Tinlarebant's efficacy in reducing lesion growth by 36% compared to placebo.

Tinlarebant works by lowering serum retinol binding protein 4 (RBP4) levels, reducing harmful bisretinoids in the eye. This breakthrough offers hope for over 50,000 STGD1 patients in the U.S., as there are currently no approved treatments. Belite Bio plans to file a New Drug Application (NDA) with the FDA in the first half of 2026, marking a crucial step towards commercialization.

Following the trial results, BLTE's stock price rose to approximately $153.59, an increase of about 11.75% or $16.15. The stock has fluctuated between $130.06 and $154.99 today, with the latter being its highest price in the past year. BLTE's market capitalization stands at approximately $5.36 billion, with a trading volume of 596,581 shares, indicating strong investor interest.