Belite Bio Announces UK’s Medicines and Healthcare Products Regulatory Agency Agrees to Conditional Marketing Authorization Application Based on Interim Analysis Results for the Treatment ...
Belite Bio, Inc - American Depositary Shares (BLTE)
Company Research
Source: GlobeNewswire
MHRA response is based on the Phase 3 DRAGON interim analysis results Topline final data expected in Q4 2025 SAN DIEGO, Nov. 02, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has agreed to accept a Conditional Marketing Authorization application for Tinlarebant for the treatment of Stargardt disease based on the interim analysis results from the Phase 3 DRAGON trial. “We are extremely pleased with the outcome of our engagement with the MHRA. This is an incredibly exciting time for the Belite team as we see our perseverance bringing us closer to offering an effective therapy to patients living with Stargardt disease, who currently have no approved treatment options,” said Dr. Tom Lin, Chairman and CEO of Belite B
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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