Can a High-Dose Strategy Revive Novo Nordisk’s Prospects?

The Danish pharmaceutical giant Novo Nordisk is mounting a strategic counteroffensive amid significant market pressure. Following a substantial setback with failed Alzheimer's trials, the company is now placing a major bet on a high-dose version of its blockbuster drug, Wegovy. Regulatory approval from the U.S. Food and Drug Administration (FDA) could be granted within weeks. This pivotal move raises a critical question for investors: is this enough to stabilize the company's recently battered equity?

The context for this strategic push is a challenging period for Novo Nordisk. The stock has been in a decline since November 24, triggered by the disappointing outcome of the EVOKE studies. The investigational oral semaglutid failed to demonstrate significant effect in early Alzheimer's disease, eliminating a potential future growth avenue that some market participants had anticipated.

Competitive pressures are also intensifying from multiple fronts. Rival Eli Lilly's Zepbound (tirzepatid) has demonstrated efficacy in the 20% weight loss range, setting a high bar. Furthermore, in early November, Pfizer secured access to a promising GLP-1 candidate, MET-097i from Metsera, in a deal worth approximately $10 billion. Early trial data for this compound shows weight reduction of around 14%—not yet at Novo's level but a clear signal of heavy investment by major industry players.

The company's third-quarter 2025 results underscored these tensions, with earnings per share of about $0.70 and revenues between $11.5 and $11.8 billion missing certain expectations. Supply constraints and pricing pressures continue to weigh on operations.

The High-Dose Gambit: Clinical Data and Timeline

In late November, Novo Nordisk filed for FDA approval of a 7.2-mg formulation of Wegovy. A crucial tactical advantage is the application's review under the expedited Commissioner's National Priority Voucher Program. This could shorten the decision timeline to just one to two months, with a verdict expected potentially in January or February 2026, rather than the standard ten-month review.

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

The clinical foundation for this application comes from the STEP UP trial, which yielded compelling results:

• Average Weight Loss: 20.7% over a 72-week period
• Superior Efficacy: This represents a significant improvement over the standard 2.4-mg dose, which showed 17.5% reduction
• High Responders: Approximately one-third of trial participants achieved a weight loss of 25% or greater

This high-dose strategy is a direct competitive response aimed at reclaiming leadership in the lucrative obesity treatment market. The battle for dominance in this multi-billion dollar segment is entering a new, more intense phase.

The Path Forward for Investors

A clear timeline is now coming into focus for the market. The first quarter of 2026 is set to be decisive. A swift FDA endorsement of the 7.2-mg dose would equip Novo Nordisk with a powerful new product to compete effectively against Eli Lilly and could provide fundamental support for its valuation.

Currently, the shares are attempting to establish a floor after recent declines. Bullish investors are searching for signs of stabilization, with many hoping that forthcoming regulatory support from the U.S. will serve as the catalyst for a sustained recovery. The coming weeks will reveal whether this high-dose offensive can successfully alter the company's trajectory.