Novo Nordisk Seeks Revival with Key Regulatory Submission

Danish pharmaceutical giant Novo Nordisk is taking decisive action to reclaim its competitive standing after a challenging period for its stock. The company’s share price has declined by more than half since the start of the year. A pivotal strategic move now centers on the official submission for its new combination drug, CagriSema, to the U.S. Food and Drug Administration (FDA), aiming to solidify its position in the rapidly expanding obesity treatment market.

Despite the significant pressure on its equity value, the firm's underlying business continues to show growth. For the first nine months of 2025, Novo Nordisk reported a 15% increase in revenue, with its adjusted operating profit advancing by 10%. The steep decline in the share price has led to a notable normalization of its valuation metrics. The price-to-earnings (P/E) ratio has fallen from over 30 a year ago to approximately 12 currently.

A Critical Submission Amidst Intense Competition

The regulatory filing arrives at a crucial juncture. Novo Nordisk shares have faced substantial selling pressure, recording a year-to-date loss exceeding 52%. A primary driver of this downturn is fierce competition from U.S. rival Eli Lilly. Just yesterday, Lilly presented positive data for a weight-control tablet, underscoring the intense innovation race within the sector.

Market researchers at Goldman Sachs forecast that the global weight-loss market could reach a value of $95 billion by 2030. To maintain competitiveness in this lucrative environment, Novo Nordisk implemented significant cost-cutting measures in 2025, including the elimination of 9,000 positions worldwide. The company also moved to bolster its development pipeline through the acquisition of Akero Therapeutics.

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

Inside the New Combination Therapy

On Friday, December 19, 2025, Novo Nordisk confirmed the submission of a New Drug Application (NDA) for CagriSema. This weekly injection combines two mechanisms of action: semaglutid (the active ingredient in Wegovy and Ozempic) and the amylin analogue cagrilintid. If approved, it would be the first combination therapy of its kind available on the market.

Clinical results from the Phase III "REDEFINE 1" trial support the company's ambitions. Patients using semaglutid alone achieved a 14.9% reduction in body weight. In contrast, those on the new combination therapy saw an average weight loss of 20.4% after 68 weeks. This marked efficacy advantage is central to Novo Nordisk's strategy for differentiating itself against strengthening competitors.

Upcoming Catalysts for Investors

Looking ahead, several key events are scheduled that will likely influence the stock's trajectory. Beyond the ongoing review process for CagriSema, a regulatory decision from the FDA on an oral version of Wegovy is anticipated before the end of 2025. Investors are also focusing on February 4, 2026, when Novo Nordisk is scheduled to release its full-year 2025 financial results and provide detailed guidance for the 2026 fiscal year.