New Hope for People Living with a Disease Once Deemed Untreatable: Belite Bio Announces Positive Topline Results from the Pivotal Global, Phase 3 DRAGON Trial of Tinlarebant in Adolescents...
Belite Bio, Inc - American Depositary Shares (BLTE)
Company Research
Source: GlobeNewswire
Tinlarebant is the first therapeutic candidate to demonstrate clinical efficacy in a global Phase 3 trial for Stargardt disease, achieving a statistically significant p-value of 0.0033Tinlarebant met the primary efficacy endpoint, demonstrating clinical benefit by significantly reducing the lesion growth rate by 36% compared to placebo, as measured by retinal imagingTinlarebant was well tolerated throughout the trial Stargardt disease impacts more than 50,000 patients in the U.S. Belite Bio plans to file an NDA with the US FDA in 1H 2026Company will host a conference call and webcast today at 8:00 a.m. ET SAN DIEGO, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio” or the “Company”) today announced topline results from the global Phase 3 “DRAGON” trial of Tinlarebant, marking the first successful pivotal trial in patients with Stargardt disease type 1 (STGD1). STGD1 is an eye disease that leads to progressive vision loss, usually beginning in childhood
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News
- Has Belite Bio's 134% 2025 Surge Fully Reflected Its DCF and Book Value Picture [Yahoo! Finance]Yahoo! Finance
- Belite Bio (NASDAQ:BLTE) was given a new $187.00 price target on by analysts at BTIG Research.MarketBeat
- Belite Bio (NASDAQ:BLTE) had its "buy" rating reaffirmed by analysts at Benchmark Co..MarketBeat
- Belite Bio (NASDAQ:BLTE) was upgraded by analysts at Mizuho from a "hold" rating to a "strong-buy" rating.MarketBeat
- Belite Bio (NASDAQ:BLTE) was given a new $200.00 price target on by analysts at Maxim Group.MarketBeat
BLTE
Earnings
- 11/10/25 - Miss
BLTE
Sec Filings
- 12/2/25 - Form 424B5
- 12/2/25 - Form 6-K
- 12/1/25 - Form 424B5
- BLTE's page on the SEC website