Belite Bio Inc ADR Dossier
Outlook & Key Dates
Estimates, guidance, catalysts, and upcoming events
Analyst Estimates Learn more →
Analyst Coverage
8analysts covering
FY EPS (est.)
-$2.95next fiscal year
Reporting Calendar
| Event | Expected Date |
|---|---|
| PHOENIX Phase 3 trial interim analysis readout | 31 Dec 2026 |
Monitoring Framework
Key Performance Indicators
Tinlarebant NDA Review Status (FDA) QuarterlyTarget: FDA Acceptance of NDA and Assignment of PDUFA Date
PHOENIX Phase 3 Trial Enrollment & Progress Annually529.0Target: Interim Analysis Readout
DRAGON II Phase 2/3 Trial Enrollment Annually72.0Target: Trial Completion and PMDA Submission
Cash and Cash Equivalents (including Treasury Bills/Notes) Quarterly798.6MTarget: Sufficient runway for commercial launch and clinical trials
Watch Items
- FDA 60-day filing review of Tinlarebant NDATrigger: FDA acceptance or Refusal to File (RTF) letterAction: Monitor regulatory announcements within 60 days of the June 12, 2026 submission.
- PHOENIX Phase 3 trial interim analysis in Geographic AtrophyTrigger: Efficacy and safety data readout in H2 2026Action: Evaluate clinical efficacy in dry AMD/GA to assess pipeline expansion potential.
- FDA requirement for a second Phase 3 trial in STGD1Trigger: FDA feedback during NDA review requesting additional clinical dataAction: Re-assess commercial launch timeline (currently projected for early 2027) and cash burn projections.
Research as of 19 Jun 2026