Belite Bio Completes Enrollment in the DRAGON II Clinical Trial of Tinlarebant for Stargardt Disease (STGD1)
Belite Bio, Inc - American Depositary Shares (BLTE)
Company Research
Source: GlobeNewswire
Tinlarebant is the first therapeutic candidate to demonstrate clinical efficacy in Stargardt disease, having met the primary endpoint in the pivotal, global Phase 3 DRAGON trial with 36% reduction in lesion growth (p-value=0.0033)60 adolescent STGD1 subjects enrolled in DRAGON II clinical trial across Japan, the United States, and the United KingdomBelite Bio plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in 1H 2026 SAN DIEGO, Jan. 27, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced the completion of enrollment of 60 subjects, including 15 Japanese subjects, in the Phase 2/3 DRAGON II clinical trial evaluating tinlarebant for the treatment of Stargardt disease type 1 (STGD1). DRAGON II clinical trial is a global, 24-mo
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News
- Belite Bio Announces Participation at the 41st Asia-Pacific Academy of Ophthalmology Congress (APAO)GlobeNewswire
- Belite Bio (NASDAQ:BLTE) had its "buy" rating reaffirmed by analysts at HC Wainwright. They now have a $185.00 price target on the stock.MarketBeat
- Belite Bio On A Tear As It Approaches Key Regulatory Submissions [Seeking Alpha]Seeking Alpha
- Belite Bio (NASDAQ:BLTE) is now covered by analysts at Bank of America Corporation. They set a "buy" rating and a $195.00 price target on the stock.MarketBeat
- Belite Bio (NASDAQ:BLTE) was given a new $191.00 price target on by analysts at Morgan Stanley. They now have an "overweight" rating on the stock.MarketBeat
BLTE
Earnings
- 11/10/25 - Miss
BLTE
Sec Filings
- 1/30/26 - Form S-8
- 1/27/26 - Form 6-K
- 12/10/25 - Form SCHEDULE
- BLTE's page on the SEC website