Novo Nordisk’s Strategic Moves Face Market Skepticism
11.12.2025 - 16:05:04Novo Nordisk DK0062498333
Despite a series of strategic advances, Novo Nordisk shares remain under significant pressure this year, even after a recent partial recovery. The company is aggressively executing its obesity strategy, having finalized the acquisition of Akero Therapeutics while simultaneously pursuing higher Wegovy doses and new drug candidates. This divergence between operational progress and stock performance raises questions about the market's current valuation.
A key development for Novo Nordisk is the pursuit of an expanded label for its blockbuster drug, Wegovy. On November 26, the company submitted a supplemental New Drug Application (sNDA) to U.S. regulators for a higher 7.2 mg dose of semaglutide injection, intended for long-term weight management in adults with obesity.
This application is being reviewed under the FDA's Commissioner’s National Priority Voucher (CNPV) pilot program, which expedites the evaluation of therapies addressing national health priorities. Upon acceptance of the submission, a decision is anticipated within one to two months, representing a clear timeline advantage over standard procedures.
The submission is supported by data from the 72-week Phase 3 STEP UP trial. Results demonstrated that the 7.2 mg dose achieved an average weight loss of 20.7%, compared to 17.5% with the current 2.4 mg dose and 2.4% with a placebo. Furthermore, 33.2% of participants on the higher dose lost at least 25% of their body weight, versus 16.7% on the 2.4 mg dose. A regulatory decision from the European Medicines Agency is expected in the first quarter of 2026.
Akero Acquisition Bolsters Metabolic Pipeline
In a move to expand beyond its core diabetes and obesity franchises, Novo Nordisk completed its takeover of Akero Therapeutics on December 9. The deal, initially announced in October, makes Akero a wholly-owned subsidiary, with its shares delisted from Nasdaq. The transaction involved a cash payment of $54 per Akero share, totaling approximately $4.7 billion.
The agreement includes a non-transferable Contingent Value Right (CVR). Former Akero shareholders could receive an additional $6 per share if U.S. regulators approve the lead candidate, efruxifermin (EFX), for treating compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH). This would increase the total deal value by roughly $0.5 billion.
The acquisition provides Novo Nordisk with an advanced MASH pipeline. EFX is currently in three Phase 3 trials: SYNCHRONY Histology for patients with pre-cirrhotic MASH (fibrosis stage F2–F3); SYNCHRONY Outcomes for patients with compensated cirrhosis (F4) due to MASH; and SYNCHRONY Real-World for patients with MASH or MASLD in routine care.
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Share Performance and Analyst Caution
The equity's performance in 2025 illustrates the depth of market skepticism. Since the start of the year, the share price is down approximately 51%, and it has declined about 60% over a twelve-month period. The stock closed yesterday at €41.95, remaining far from its 52-week high, though the distance to its low sits at just over 7%—a chart pattern suggesting potential consolidation rather than a sustained rally.
Analyst sentiment reflects this caution. Bank of America recently reaffirmed its neutral rating, adjusting its price target to 340 DKK. Concerns cited include discussions around the planned launch of CagriSema and the broader shaping of the obesity pipeline.
Several headwinds are weighing on investor sentiment:
- Intensifying competition from Eli Lilly's Mounjaro and Zepbound
- Pricing pressure in the critical U.S. market
- Management restructuring following intervention by the Novo Nordisk Foundation
- Mixed clinical trial data, including the failure of Alzheimer's programs in late November
Technically, the share price remains below its 200-day moving average. A 14-day Relative Strength Index (RSI) of 34.8 indicates weakened but not extremely oversold conditions, while elevated 30-day volatility of nearly 40% underscores ongoing market uncertainty.
Operational Levers for Future Growth
Strategically, Novo Nordisk is working on multiple fronts to solidify and expand its position in metabolic diseases.
- Oral semaglutid for weight management is anticipated to receive U.S. approval before the end of 2025.
- The combination therapy CagriSema (semaglutide and cagrilintide) continues to progress through clinical development.
- The candidate amycretin showed promising Phase 2 data, with type 2 diabetes patients achieving 14.5% weight loss after 36 weeks.
- The company plans a market expansion into India with the launch of Ozempic in December 2025.
In the near term, investor focus will center on three key events: the FDA decision on oral semaglutide for obesity, the accelerated review outcome for the higher Wegovy dose, and the full-year 2025 financial results in February 2026. Together with the completed Akero acquisition, these milestones will test whether Novo Nordisk can successfully translate its pipeline advancements into tangible growth and alleviate pressures from competition and pricing challenges.
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