other material
confidence high
sentiment positive
materiality 0.70
Xeris details XP-8121 Phase 3 plan; expects $1-3B peak revenue, launch in 2030
Xeris Biopharma Holdings, Inc.
- Phase 3 Cornerstone study: 500 patients, 1:1 vs oral levothyroxine, 54 weeks, primary endpoint TSH normal at weeks 48/54.
- Topline results expected late 2028; FDA approval and launch anticipated 2030.
- Peak net revenue potential $1-3 billion for once-weekly subcutaneous levothyroxine.
- Additional studies: pediatric (Capstone), special population (Touchstone), real-world evidence.
- KOL Dr. David Robertson to serve as Cornerstone investigator.