Novo Nordisk Seeks US Approval for New Weight-Loss Drug Amid Pricing Shift

Danish pharmaceutical giant Novo Nordisk has taken a significant step in its obesity treatment portfolio by submitting CagriSema, a new combination drug, for approval to the U.S. Food and Drug Administration (FDA). This strategic move coincides with the company's inclusion in a new drug pricing framework recently announced by the Trump administration, setting the stage for potential shifts in both its market prospects and financial performance.

Despite current market skepticism reflected in a share price trading below its moving averages, major institutional investors appear confident in Novo Nordisk's trajectory. Recent filings reveal that U.S. Capital Wealth Advisors increased its stake by 93.2% during the third quarter. Simultaneously, Perpetual Ltd. established a new position comprising nearly 65,000 shares. This activity suggests that large-scale investors view regulatory challenges as manageable and are betting on the firm's innovative pipeline to drive long-term value. Market analysts note that a decisive break above the $50 resistance level, potentially fueled by positive regulatory news, could signal an end to the stock's multi-month corrective phase.

CagriSema: A Potential Growth Engine from 2026

The FDA submission for CagriSema represents a pivotal development in the company's product pipeline. The once-weekly therapy combines two active ingredients—cagrilintide and semaglutide, the latter already known from the blockbuster drug Wegovy. Clinical studies indicate the combination may offer superior weight reduction efficacy.

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This timing is viewed as strategically critical, given the intensifying competition in the obesity medication market, notably from rival Eli Lilly. Should it receive regulatory clearance, CagriSema is positioned to become a major growth driver for Novo Nordisk starting in 2026. The FDA's decision on the application is anticipated by the end of that year.

Navigating a New U.S. Pricing Landscape

Concurrent with its drug submission, Novo Nordisk is confronting a changed regulatory environment in the United States. On December 19, President Trump unveiled a pricing agreement with nine pharmaceutical companies, including Novo Nordisk. The "Most Favored Nation" clause within this agreement obligates participating firms to align prices for certain medications with international averages.

This policy is expected to exert downward pressure on per-unit profit margins. In exchange, it promises facilitated access to major government healthcare programs like Medicaid and Medicare, which could significantly boost sales volumes. For established products like Wegovy and, prospectively, for CagriSema, this translates to a potential trade-off: lower profit per dose but a substantially expanded patient base.