BELITE BIO, INC
BLTENext catalyst
Tinlarebant
Stargardt Disease Type 1
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Plus 2 more upcoming events in our data (earnings, Phase 3 readout).See the timeline
3 upcoming, 0 past
BLTE Earnings Report
Date estimated from past reporting pattern, not yet confirmed by the company | EPS Est: $-0.73 | FQ end Sep/2026 | Call: tbd
FDA PDUFA Date Tinlarebant (priority review)
For Stargardt Disease Type 1. NDA filing. AI-extracted from news: Belite Bio Announces U.S. Food and Drug Administration Acceptance and Priority Review of New Drug Ap
SourceTinlarebant Phase 3 Est. Readout (PHOENIX)
Primary completion for Tinlarebant trial (NCT05949593) in Geographic Atrophy
SourceUpcoming FDA decisions
Market Overview
Stock performance and key metrics
| Drug Name | Phase | Indication | Designations | Patent |
|---|---|---|---|---|
Tinlarebant | Phase 3 | STGD1 | - | - |
Frequently asked questions
What is in BELITE BIO, INC's drug pipeline?→
CatalystAlert tracks 1 drug candidate in BELITE BIO, INC's (BLTE) pipeline across Phase 3. Its lead program is Tinlarebant (Phase 3). Each drug's phase, indication and upcoming catalysts are listed on this page.
When is BELITE BIO, INC's next FDA catalyst?→
BELITE BIO, INC's (BLTE) next tracked catalyst is a PDUFA date expected Feb 12, 2027. See the catalyst timeline on this page for the full schedule of PDUFA dates, trial readouts and FDA events.
How do I track BLTE biotech catalysts?→
Add BLTE to your CatalystAlert watchlist for alerts ahead of each catalyst, and follow BELITE BIO, INC's live catalyst calendar, drug pipeline and clinical-trial timeline on this page — sourced from ClinicalTrials.gov, FDA and SEC filings.