Novo Nordisk’s CagriSema: A Pivotal Asset in the Obesity Market Battle

Facing intense competitive pressure, Novo Nordisk is advancing a new combination therapy, CagriSema, through the regulatory pipeline. This move represents a strategic bid to reclaim momentum in the high-stakes obesity drug market, where rival Eli Lilly has been gaining ground. The company's shares, having endured a significant downturn in 2025, now hinge on the successful development and approval of this and other pipeline assets.

Novo Nordisk recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for CagriSema, a once-weekly injectable combination treatment for obesity. The therapy merges two components:
* cagrilintide, a novel amylin analogue
* semaglutid 2.4 mg, the active ingredient in the blockbuster drug Wegovy

By targeting complementary metabolic pathways, the fixed-dose combination aims to produce more substantial effects than either agent could achieve alone.

Compelling Clinical Trial Results

The FDA submission is underpinned by data from the phase 3 REDEFINE 1 trial, which involved 3,417 overweight or obese adults without diabetes over 68 weeks. Participants were randomized to receive CagriSema, semaglutid alone, cagrilintide alone, or a placebo.

Key outcomes from the study include:

• Weight Reduction: Patients on CagriSema achieved an average body weight loss of 22.7% (using the Trial-Product Estimand). The Treatment-Policy approach, which includes therapy discontinuations, showed a 20.4% reduction.
• Composition of Loss: Approximately 84% of the lost weight was fat mass, with functional tests suggesting preserved muscle.
• High Threshold Achievement: Notably, 40.4% of participants lost at least 25% of their body weight, and 23.1% achieved a reduction of 30% or more.
• Safety Profile: Adverse events were primarily gastrointestinal, consistent with the known profile of GLP-1 receptor agonists.

The FDA's review process is anticipated to unfold throughout 2026, representing a major potential catalyst for the stock.

Share Performance and Valuation Context

Novo Nordisk's equity has faced substantial headwinds. Since the start of 2025, the share price has been more than halved, showing a decline of roughly 59% over a twelve-month period. Closing at 41.08 euros on Friday, the stock traded just a few percentage points above its recent 52-week low, a stark contrast to its high near 99.86 euros.

The price-to-earnings ratio, cited in the source material at approximately 14, sits well below the company's own ten-year average. This compressed valuation reflects several challenges:
* Slowing growth for Wegovy in the U.S. market
* Escalating competition from Eli Lilly's Zepbound
* Pressure from compounding pharmacies creating copycat versions of GLP-1 ingredients
* Repeated earnings forecast downgrades during 2025

Should investors sell immediately? Or is it worth buying Novo Nordisk?

A Relative Strength Index (RSI) reading of 34.8 indicates the stock is technically weak but not yet in deeply oversold territory.

Broadening the Pipeline Beyond a Single Product

While CagriSema is a focal point, Novo Nordisk's strategy involves diversifying its portfolio. Recent developments highlight this multi-pronged approach:

• Wegovy 7.2 mg (High Dose): On December 12, 2025, the higher-dose formulation received a positive opinion from the European Medicines Agency. Clinical studies demonstrated an average weight loss of 20.7%, significantly exceeding previous standards.
• Oral Semaglutid (Obesity Pill): The company is concurrently developing a tablet version for obesity treatment, with a potential regulatory window around 2026. Analysts see oral therapies as a key lever to substantially broaden the accessible market.
• Acquisition of Akero Therapeutics: Finalized in December 2025, this deal expands Novo Nordisk's pipeline in metabolic medicine, strengthening its foothold in adjacent treatment areas and supporting its long-term ambition to lead in metabolic diseases.

Leadership and Strategic Oversight Changes

2025 was also a year of transition in the boardroom and executive suite. Mike Doustdar assumed the CEO role from Lars Fruergaard Jørgensen in August. Furthermore, the board of the Novo Nordisk Foundation—the company's dominant owner—underwent a comprehensive reshuffle in November.

Former CEO Lars Rebien Sørensen was appointed chairman. The foundation cited the need for "fresh eyes" and renewed energy to support management through the ongoing corporate transformation, signaling a tighter integration of governance and strategic direction.

Market Potential and Forthcoming Catalysts

The global market for obesity medications is projected to reach an annual volume of approximately $150 billion by the early 2030s. According to research from Goldman Sachs, oral therapies could capture about 24% of this market by 2030—a segment where Novo Nordisk aims to compete with its oral semaglutid.

Several near-term events will be critical for investors to monitor:
* 2025 Full-Year Results: Scheduled for release on February 4, 2026.
* FDA Review of CagriSema: The regulatory examination is expected to span 2026.
* Decision on Oral Semaglutid: A potential approval could occur in late 2025 or early 2026.
* U.S. Approval for Wegovy 7.2 mg: A decision is expected within months of the formal application acceptance.

Conclusion: Defined Catalysts Amidst Challenges

As Novo Nordisk enters 2026, its shares carry the weight of recent underperformance but are supported by several clearly defined potential catalysts. CagriSema stands out, with phase 3 data showing over 20% average weight loss and high rates of profound reduction, providing a compelling counter to Eli Lilly's offerings. When combined with the high-dose Wegovy variant, the oral semaglutid development, and the expanded pipeline via the Akero acquisition, the company has multiple avenues to address market concerns and recalibrate its position in the obesity sector. The pace and success of upcoming regulatory and commercial milestones will be decisive.