Novo Nordisk AS (NYSE:NVO), once the darling of the pharmaceutical world, tumbled Monday as investors reacted to what analysts are calling a “worst-case scenario.” 

• NVO stock is tumbling. See the chart and price action here. 

Shares of Novo Nordisk stock plunged over 16% in morning trading, hitting a new 52-week low following disappointing results from the REDEFINE 4 Phase 3 clinical trial. 

This latest blow brings the stock’s one month decline to 36%.

The Data Gap: CagriSema vs. Tirzepatide

The market’s distress stemmed from the head-to-head comparison between Novo's next-generation weight-loss drug, CagriSema (a combination of cagrilintide and semaglutide), and Eli Lilly & Co.'s (NYSE:LLY)  tirzepatide (marketed as Zepbound and Mounjaro).

The 84-week trial involving 809 subjects failed to meet its primary endpoint of non-inferiority. 

The efficacy results were clear:

• Adherent Treatment: Patients on CagriSema achieved a weight loss of 23.0%, compared to 25.5% for those on tirzepatide.
• Treatment Regimen Estimand: Under this measure, CagriSema showed 20.2% weight loss versus 23.6% for tirzepatide.

While CagriSema maintained a safe and well-tolerated profile—with gastrointestinal side effects consistent with the GLP-1 class—the failure to match or beat Eli Lilly's flagship drug shifted the competitive landscape.

Expert Reactions and Market Implications

The fallout from the REDEFINE 4 data was immediate. 

According to a Zero Hedge report, a Bloomberg Intelligence analyst noted that “this outcome is the worst-case scenario for Novo and heightens the need for M&A with Novo's other GLP-1/Amylin drug.”

Danske Bank Credit Research analyst Brian Borsting highlighted the strategic vulnerability.  

"Clearly this weakens Novo Nordisk's competitive stance in the obesity market – especially if the obesity market develops into a ‘winner takes it all' market," Borsting said, per Zero Hedge. 

Borsting added that while Novo's portfolio remains solid and diversified, the news is undeniably “credit negative.”

The Path Forward

Despite the setback, Novo Nordisk management is looking toward future milestones. 

Martin Holst Lange, executive vice president of R&D, remarked: "Based on the learnings from completed studies, we look forward to the REDEFINE 11 readout and the initiation of the higher-dose CagriSema trial, which are both designed to assess the full weight-loss potential of CagriSema."

Novo Nordisk has already submitted CagriSema to the FDA for approval based on earlier REDEFINE trials, with a decision expected by late 2026. 

However, with the higher-dose trial not slated to begin until late 2026 and REDEFINE 11 results not due until 2027, Novo faces a grueling climb to regain market dominance.

Photo: Piotr Swat / Shutterstock

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