Novo Nordisk Secures Dual EU Backing for Wegovy as Semaglutide Liver Data Strengthens Pipeline
25.05.2026 - 10:33:36 | boerse-global.de
The Danish pharmaceutical giant is firing on multiple fronts. This week alone, the European Medicines Agency’s CHMP recommended two major Wegovy expansions — a high-dose pen and the first-ever oral GLP-1 pill for weight loss in Europe — while Novo Nordisk presented fresh semaglutide data at the EASL liver congress in Barcelona, targeting a neglected chronic disease that affects 250 million people worldwide.
A regulatory double blow in obesity
The CHMP’s endorsement of the 7.2 mg Wegovy once-weekly pen consolidates a key improvement in patient convenience. Previously, EU patients needing this dosage had to administer three separate 2.4 mg injections. The single pen removes that burden, building on the Phase 3 STEP UP study, where participants lost an average of 20.7% of body weight over 72 weeks, and roughly a third shed 25% or more. For patients with type 2 diabetes, the figure came to 14.1%. Already on sale as Wegovy HD in the UK and US, the product is slated for an EU launch in the third quarter of 2026.
Even more significant is the CHMP’s green light for a 25 mg daily oral Wegovy tablet — the first oral GLP-1 receptor agonist for weight reduction to reach the European market. The OASIS 4 study showed an average weight loss of 16.6% in adherent patients, while the SELECT trial indicated a reduced risk of major cardiovascular events such as heart attack and stroke. In the US, where the pill is already available, it generated roughly 1.3 million filled prescriptions in its first four months and quarterly sales of DKK 2.3 billion — nearly double analyst expectations. Subject to final European Commission approval, select EU markets will see the oral Wegovy in the second half of 2026.
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Beyond weight loss: semaglutide’s liver ambition
While regulatory momentum in obesity builds, Novo Nordisk is also expanding the therapeutic reach of its core asset. At the EASL conference, the company unveiled subgroup analyses from the Phase 3 ESSENCE program, showing that 2.4 mg semaglutide significantly reduced liver inflammation and fibrosis in patients with MASH (metabolic dysfunction-associated steatohepatitis), a progressive liver disease that remains undiagnosed in nine out of ten cases. The safety profile remained favourable, with the data now covering special populations such as postmenopausal women. The liver indication opens a sizable new addressable market — MASH is a leading cause of liver transplants and has long been underserved by pharmacological options.
Buyback and stock recovery
Underpinning the clinical and regulatory push, Novo Nordisk is executing a massive share buyback of up to DKK 11.2 billion, set to run through February 2027 as part of a total tranche of DKK 15 billion. Meanwhile, the stock has recovered from recent lows: currently trading around EUR 39, it has gained roughly 11% over the past month, though it still sits more than 12% lower year-to-date and nearly 45% below its 52-week high of EUR 70.13. The upcoming catalysts — half-year results on 5 August, a capital markets day on 21 September, and a US regulatory decision on the combination therapy CagriSema in the fourth quarter — will test whether the recent recovery has legs.
Competitive heat intensifies
The timing of the EU endorsements is hardly coincidental. The obesity drug market is forecast to reach USD 150 billion within a decade, and rivals are moving fast. In April 2026, Eli Lilly launched Foundayo, an oral alternative in the US that, unlike Wegovy’s pill, does not require fasting before administration. Novo Nordisk’s regulatory wins in Europe give it a head start in the region, but the battle for oral GLP-1 supremacy is only just beginning. How quickly the new Wegovy formulations penetrate EU markets will be the decisive factor in whether the stock can sustain its upward trajectory.
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