Novo Nordisk’s Oral Wegovy Nears EU Approval as Weight-Loss Pill Shifts Competitive Dynamics

CHMP recommends 25-mg semaglutide tablet for weight management and CV risk; first oral GLP-1 in EU. Novo plans 2026 rollout, faces competition from Lilly.

Novo Nordisk’s push into oral GLP-1 therapy took a decisive step forward after the European Medicines Agency’s CHMP committee recommended approval of a 25-milligram semaglutide tablet for weight management and cardiovascular risk reduction. The same panel also gave the nod to a high-dose 7.2-milligram injectable version of Wegovy, broadening the Danish drugmaker’s arsenal in the obesity market. The final decision rests with the European Commission, but a green light would make the pill the first oral GLP-1 treatment of its class to receive such a recommendation in the EU.

The recommendation draws on data from the phase 3 OASIS 4 trial, where patients posted an average weight loss of 16.6%. More than a third of participants shed at least a fifth of their body weight. Novo Nordisk plans to roll out the tablet in selected markets outside the United States in the second half of 2026, aiming to capture a cohort of patients who have shunned injections.

In the US, where the pill has been available since January, adoption has been swift. More than 2 million prescriptions have been written since launch, with over 1 million patients initiating therapy in the first four months. That rapid uptake underscores the appetite for an oral alternative to the injectable GLP-1s that have reshaped the obesity landscape.

Yet the competitive terrain is shifting fast. Eli Lilly’s once-daily oral candidate Foundayo (orforglipron) secured US approval on April 1, and pharmacy benefit manager CVS Caremark added it to its formulary on June 1. CVS also plans to restore Zepbound, Lilly’s injectable obesity drug, as a preferred option starting in October. Novo Nordisk’s Wegovy products retain preferred status for now, but the days of exclusive positioning in pharmacy networks are over.

The market has already priced in the headwinds. Novo Nordisk shares have fallen 12.5% since the start of the year, closing at €39.08 on the day of the CHMP news. The stock trades at a price-earnings ratio of roughly 10.5, a steep discount to its historical average of 26. The dividend yield has climbed to around 4%, and the relative strength index of 47.6 suggests neither overbought nor oversold conditions. While the shares have gained 13.13% over the past 30 days, they remain 35.69% below their level of 12 months ago.

Financially, the company continues to deliver robust growth. First-quarter 2026 revenue jumped 34% to $14.97 billion, with obesity sales rising 22%. Pricing pressure in the US and China has clipped some of the margin gains, but international business still expanded 6%. Gross margins held steady at 80.6%, helped by heavy investments in global production capacity aimed at easing the supply bottlenecks that have dogged injectable products.

The CHMP recommendation also incorporates data from the SELECT study, which demonstrated that semaglutide reduces the risk of major adverse cardiovascular events. That dual benefit – weight loss and heart protection – could give Novo Nordisk a crucial edge as Eli Lilly and Pfizer push their own oral programs. At the recent ADA Scientific Sessions, the company presented early-stage data on CagriSema and Zenagamtide, next-generation candidates designed to strengthen its cardiometabolic pipeline beyond classic GLP-1s.

Technically, the stock sits in a neutral zone: above its 50-day moving average of €35.16 but below the 200-day average of €41.99. The real test will come when the oral Wegovy reaches European pharmacy shelves in 2026. For now, the EU recommendation provides a strategic pivot point – but the market wants to see whether doctors and patients will embrace the tablet as widely as they have the shot.