Novo Nordisk Dual Pipeline Advances: High-Dose Wegovy Fat-Loss Data and Hemophilia Drug Near Approval

Novo Nordisk reveals STEP-UP trial data for high-dose Wegovy showing 21% weight loss with muscle preservation, alongside hemophilia progress, while Q1 earnings beat and guidance upgrade offset stock declines.

Novo Nordisk is firing on two fronts this week, releasing compelling clinical updates from both its obesity and hemophilia pipelines. The Danish drugmaker presented detailed results from the STEP-UP study on the 7.2-milligram version of Wegovy at the European Obesity Congress in Istanbul, while also seeing its hemophilia asset Denecimig published in the New England Journal of Medicine. These developments come as the company works to rebuild investor confidence after a sharp sell-off that has left shares trading at roughly half their 2024 peak.

The stock closed Friday at €38.51, down 1.95% on the day. Over the past month, the shares have bounced back with an 11.57% gain, yet the longer-term picture remains bleak: the stock is off 13.81% year-to-date and has tumbled 35.02% over the last twelve months. That deep drawdown reflects persistent concerns about pricing pressure in the US market and the threat of patent expirations in Asia.

Wegovy High Dose Shows Fat Preservation

The STEP-UP trial evaluated the 7.2 mg dose over 72 weeks. Patients lost an average of 21% of their body weight, or roughly 23 kilograms at a typical starting weight. But the headline weight-loss number was only part of the story. MRI scans performed on a subgroup revealed that 84% of the lost mass came from fat, while muscle mass declined by just 10%. Novo Nordisk highlighted improved muscle health due to reduced intramuscular fat, and a standardized sit-to-stand test confirmed that treated patients maintained leg strength.

The high-dose formulation directly challenges Eli Lilly’s Zepbound, which has often been favored because it delivers average weight loss above 20%. Novo Nordisk is now narrowing that gap. Early responders within the STEP-UP study — about 27% of patients on the high dose — shed at least 15% of their weight in the first 24 weeks. By week 72, this group achieved nearly 28% weight loss. The high-dose version is already being shipped, and major US pharmacy benefit managers have added it to their standard formularies.

Quarterly Results and Upgraded Guidance

The clinical wins arrived alongside first-quarter earnings that prompted management to raise full-year guidance for both adjusted revenue and operating profit. Reported revenue came in at $14.97 billion, well above expectations, though the beat was partly due to a one-time reserve reversal in the US. Earnings per share of $1.03 missed analyst estimates.

Adjusted revenue reached 70.1 billion Danish kroner, which on a currency-adjusted basis represents a 4% decline — underscoring how special items are distorting the underlying picture. Net profit came in at 48.6 billion Danish kroner, and free cash flow stood at 12.8 billion kroner, while dividends and share buybacks together totaled 37.7 billion kroner.

The US market remains the weak spot. Currency-adjusted adjusted revenue in the US fell 11%, while international business grew 6%. The adjusted gross margin contracted from 83.5% to 80.6%, reflecting competitive pricing and higher rebates.

Pipeline Beyond Obesity: Denecimig Gains Traction

Away from the GLP-1 frenzy, Novo Nordisk’s hemophilia program is building momentum. The New England Journal of Medicine published 26-week data from the phase 3 FRONTIER2 study of Denecimig (also known as Mim8) in hemophilia A patients with and without FVIII inhibitors. Denecimig is a bispecific antibody that mimics the function of factor VIIIa and is administered subcutaneously.

Novo Nordisk submitted a marketing application to the US Food and Drug Administration in September 2025. BMO Capital projects a possible approval in the second half of 2026. While Denecimig will not replace the GLP-1 business, it offers a new revenue stream that is less tied to the obesity market and could provide diversification.

Analyst Caution Persists

Despite the positive data flow, the analyst community remains divided. Jefferies holds a “Neutral” rating with a price target of 270 Danish kroner, pointing to the risk that oral Wegovy may cannibalize existing sales more than anticipated. The bank also warns that Eli Lilly’s oral candidate Orforglipron could slow growth in the GLP-1 market. Jefferies sees the REDEFINE-4 head-to-head trial of CagriSema against Lilly’s Zepbound as a potential catalyst, but doubts a clear superiority win.

Bernstein’s Justin Smith keeps a “Sell” rating and a target of 175 Danish kroner. The consensus analyst target stands at 304 Danish kroner, which reflects the stock’s recovery but also the distance from its former valuation.

What Lies Ahead

The next significant event on the calendar is the half-year report on August 5, 2026, where investors will focus on three key areas: US pricing dynamics, Wegovy growth momentum, and concrete progress in Denecimig’s approval timeline.

Longer-term, the company faces headwinds from patent expirations in China and Canada, where generic competitors are preparing to enter. The current share price, far below the year’s high of around €70, suggests the market is already pricing in many of these risks. For now, Novo Nordisk is betting that a deeper pipeline — from high-dose Wegovy to hemophilia — can restore its growth narrative.