Novo Nordisk Shares Hit 52-Week Low After CagriSema Fails Non-Inferiority vs Tirzepatide
Novo Nordisk’s REDEFINE 4 trial of CagriSema underperformed, achieving 23.0% weight loss versus 25.5% for Lilly’s tirzepatide at 84 weeks, failing to meet its primary non-inferiority endpoint. After the headline data, shares sank to a 52-week low and are down about 48% year-to-date.
1. REDEFINE 4 Trial Results
Novo Nordisk’s 809-subject REDEFINE 4 phase 3 trial compared CagriSema 2.4 mg/2.4 mg against tirzepatide 15 mg over 84 weeks, reporting 23.0% weight loss on treatment versus 25.5% for tirzepatide and 20.2% versus 23.6% on the treatment-regimen estimand, missing its non-inferiority primary endpoint.
2. Stock Market Reaction
Following the headline data, shares slid over 13% in premarket trading to a new 52-week low and have declined roughly 48% year-to-date, reflecting investor concerns over CagriSema’s competitive positioning in the obesity drug market.
3. Upcoming Clinical Milestones
Novo Nordisk awaits an FDA decision on CagriSema by late 2026 and plans to report REDEFINE 11 results in H1 2027, with a higher-dose CagriSema phase 3 trial expected to begin in H2 2026.