Novo Nordisk Files NDA for Next-Generation Obesity Drug CagriSema

Novo Nordisk NVO announced the submission of a new drug application (NDA) to the FDA, seeking approval for its next-generation once-weekly injection, CagriSema, to reduce excess body weight and maintain weight reduction in the long term in adults with obesity or overweight. The FDA is expected to review the application in 2026.

The candidate is intended to be used in conjunction with a reduced-calorie diet and increased physical activity in patients who have at least one weight-related comorbid condition.

CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2.4 mg and Novo Nordisk’s blockbuster obesity drug, Wegovy (semaglutide 2.4 mg). The two molecules promote weight loss by suppressing hunger, enhancing feelings of fullness and helping individuals consume fewer calories. If approved, NVO’s CagriSema would be the first injectable therapy to combine a GLP-1 RA with an amylin analogue.

How Effective is NVO’s Next-Generation Obesity Injection?

Novo Nordisk’s NDA is based on statistically significant results from two late-stage studies, the 68-week phase III REDEFINE 1 study of CagriSema in obesity patients without diabetes and the 68-week phase III REDEFINE 2 study of the candidate in obesity patients with diabetes.

In the REDEFINE 1 study, superior weight loss of 22.7% on average was achieved with CagriSema compared to 2.3% with placebo alone, assuming all people adhered to treatment. Additionally, NVO reported that 40.4% of patients receiving CagriSema achieved a weight loss of 25% or more compared to 0.9% with placebo, while 91.9% of patients receiving the candidate achieved a body weight reduction of at least 5% compared to 31.5% with placebo.

Analysis of the study data, regardless of treatment adherence, showed that patients treated with CagriSema achieved a superior mean weight loss of 20.4% compared to a reduction of 3% with placebo. A supportive secondary analysis also showed that nearly half of participants with obesity at baseline (54%) who received CagriSema achieved a non-obese BMI by week 68 compared with 11.1% in the placebo group.

In the past six months, shares of Novo Nordisk have lost 35.4% against the industry’s 19% growth.

In the REDEFINE 2 study, superior mean weight loss of 15.7% was achieved with CagriSema compared with a reduction of 3.1% with placebo, assuming all people adhered to treatment. The study also met its co-primary endpoint of 5% weight loss or more in 89.7% of patients on CagriSema compared with 30.3% by placebo. Analysis of the study data, regardless of treatment adherence, showed that obese and diabetic patients treated with CagriSema achieved a superior weight loss of 13.7% on average compared with 3.4% with placebo.

In both phase III studies, CagriSema was well-tolerated and demonstrated an acceptable safety profile that was comparable with the GLP-1 RA class.

We note that despite the positive results, Novo Nordisk faced massive setbacks following the announcement of these data in late 2024 and early 2025, respectively, as CagriSema demonstrated a lower-than-expected reduction in body weight.

Why is NVO Determined to Diversify its Metabolic Portfolio?

Novo Nordiskhas experienced strong momentum in the past, driven by the commercial success of its blockbuster semaglutide products, Wegovy (obesity) and Ozempic (diabetes). However, the company’s growth trajectory has suffered in recent quarters due to pricing pressure, intensifying GLP-1 competition from Eli Lilly LLY, foreign exchange headwinds, and widespread compounded semaglutide use in the United States.

Eli Lilly’s tirzepatide-based drugs, Mounjaro (for diabetes) and Zepbound (obesity), have captured rapid demand and market share, pressuring NVO’s position in both obesity and diabetes markets. Despite being on the market for less than three years, Mounjaro and Zepbound have become LLY’s key top-line drivers. In the first nine months of 2025, the drugs generated combined sales of $24.8 billion, accounting for 54% of Eli Lilly’s total revenues.

To tackle the same, Novo Nordisk is developing several next-generation obesity candidates in its pipeline while pursuing label expansions for its semaglutide franchise to entrench its leadership position, especially targeting the lucrative U.S. market. Apart from CagriSema, NVO also reported superior weight loss from a sub-analysis of its phase III REDEFINE 1 study, which tested cagrilintide injection as a monotherapy in obese adults, but without diabetes. A dedicated phase III RENEW program for cagrilintide is planned to start soon.

Novo Nordisk is developing oral and subcutaneous formulations of a mid-stage candidate, amycretin, for obesity and diabetes indications. It is also currently evaluating oral monlunabant in a mid-stage obesity study. The company recently signed a $2.2 billion deal with Septerna for developing and commercializing oral small-molecule medicines for treating obesity, diabetes, and other cardiometabolic diseases.

Novo Nordisk A/S Price and Consensus

Novo Nordisk A/S price-consensus-chart | Novo Nordisk A/S Quote

NVO’s Zacks Rank & Stocks to Consider

Novo Nordisk currently carries a Zacks Rank #5 (Strong Sell).

Some better-ranked stocks in the biotech sector are CorMedix CRMD and Castle Biosciences CSTL, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for CorMedix’s 2025 EPS have increased from $1.85 to $2.87, while 2026 EPS estimates have risen from $2.49 to $2.88 over the same period. Shares of CRMD have lost 12.4% over the past six months.

CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.

Over the past 60 days, the loss estimate for Castle Biosciences has narrowed from 64 cents to 34 cents in 2025. Over the same period, loss estimates for 2026 have improved from $1.82 to $1.06. CSTL stock has rallied 113.7% over the past six months.

Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining quarter, with the average surprise being 66.11%.

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