Pipeline

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AllPhase 1Phase 2Phase 3Phase 4Launch

Zelimibran · Halcyon · Oncology

PDUFA Sep 12
P1
P2
P3
P4
Launch
FDA accepts NDA, grants priority review
FDA · Aug 13
Phase 3 topline: 42% ORR vs 18% control
Company PR · Jul 28

Corvastat-ER · Novik · Cardiology

AdCom Sep 30
P1
P2
P3
P4
Launch
Advisory Committee date set for Sep 30
FDA · Aug 20
Briefing docs expected ~Sep 26
FDA · Aug 20

Meridocel · Alder Bio · Immunology

P2 ✓ endpoint
P1
P2
P3
P4
Launch
Meridocel hits primary endpoint in Phase 2
Company PR · Aug 22
Phase 3 initiation expected Q1 2027
Analyst note · Aug 24