Following a punishing week for its share price, Novo Nordisk has launched a strategic counteroffensive. The Danish pharmaceutical giant, still reeling from a significant clinical trial failure, is fighting back with a major regulatory move. The central question for investors is whether a new, higher-dose formulation of its weight-loss drug Wegovy can restore market confidence, or if this represents merely a temporary diversion from deeper challenges.
Regulatory Gambit: Wegovy 7.2 mg Submission
In a swift response to recent pressures, Novo Nordisk disclosed on Friday, November 28, that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration. The application seeks approval for a 7.2 mg dosage of Wegovy, a substantial increase from the currently approved 2.4 mg maintenance dose.
Clinical evidence supporting this submission appears robust:
* The Phase 3 STEP UP study demonstrated an average weight reduction of 20.7% over a 72-week period, compared to 17.5% for the 2.4 mg dose.
* Approximately 33% of trial participants achieved a weight loss of 25% or greater.
* The company is utilizing a Priority Review Voucher, which is expected to compress the FDA’s review timeline to an estimated one to two months.
This strategic initiative is widely interpreted as an effort to narrow the efficacy gap with competing products from Eli Lilly and to retain patients within the Novo Nordisk treatment ecosystem before they consider switching.
Alzheimer’s Ambitions Dashed by Clinical Trial Results
The impetus for this aggressive move stems from a major disappointment earlier in the week. On Monday, November 24, Novo Nordisk announced that its eagerly anticipated EVOKE and EVOKE+ Phase 3 trials had failed to meet their primary endpoints. These studies were investigating oral semaglutid for the treatment of Alzheimer’s disease, showing no statistically significant slowing of disease progression versus a placebo.
Financial markets reacted severely to this pipeline setback, sending Novo Nordisk shares down by nearly 10%. The failure represents a substantial blow to the company’s long-term growth strategy, which had counted on expanding semaglutid’s applications beyond diabetes and obesity into other lucrative therapeutic areas. This comes at a particularly challenging time, as competitive threats from Eli Lilly’s Zepbound portfolio and oral GLP-1 candidates intensify pressure on Novo Nordisk’s core business.
Should investors sell immediately? Or is it worth buying Novo Nordisk?
Market Response and Critical Forthcoming Events
The market’s initial reaction to the Wegovy news provided modest relief, with shares closing up 1.3% on the day of the announcement. However, this minor gain did little to recoup the substantial losses incurred earlier in the week.
All eyes are now on two key upcoming events that will likely determine the stock’s near-term trajectory:
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On December 3, 2025, at the Clinical Trials on Alzheimer’s Disease (CTAD) conference, Novo Nordisk will present detailed data from the unsuccessful EVOKE studies. Market analysts will scrutinize these results for any positive signals in specific patient subgroups that might justify continuing parts of the research program.
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A regulatory decision on the high-dose Wegovy application could arrive as early as January 2026. An FDA approval would provide a crucial commercial asset to help defend market share in the new year.
From a technical analysis perspective, the stock is currently testing critical support levels established during its 2024 consolidation phase. A breach below Friday’s closing level could signal further downward pressure, making the success of this new strategic direction all the more critical for Novo Nordisk’s recovery.
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