Oral Wegovy Wins EMA Panel Backing, Yet Novo Nordisk Shares Remain Under Pressure

EMA recommends first oral GLP-1 obesity pill for EU approval, but Novo Nordisk shares tumble 15% YTD amid pricing pressure, generic competition, and rival oral threats.

The European Medicines Agency’s human medicines committee has recommended Novo Nordisk’s oral Wegovy pill for approval, clearing the way for the first oral GLP-1 treatment for obesity in the EU. But the market response has been muted, underscoring the steep challenges the Danish drugmaker still faces on multiple fronts.

Shares in Novo Nordisk were trading at €37.82 on Friday, down roughly 15% year-to-date and nearly 46% below their 52-week high of €70.13. The stock now sits almost 36% lower than it did 12 months ago, reflecting persistent headwinds from US pricing pressure, generic competition in emerging markets, and the looming threat of rival oral therapies.

A regulatory milestone, but the final hurdle remains

The CHMP recommendation covers the once-daily 25-milligram semaglutide tablet. The endorsement will now be forwarded to the European Commission, which is required by EU rules to deliver a final decision within 67 days. If approved, Novo Nordisk plans to roll out the pill in select European countries during the second half of 2026, with the UK, Germany and Denmark seen as the most likely initial markets.

Even post-approval, the hard work is just beginning. Price and reimbursement negotiations will take place at the national level, and building supply chains and persuading physicians to prescribe the oral formulation will be critical to commercial success. “The EMA recommendation opens the door – what lies behind it will determine success,” analysts note.

Strong data and a first-mover edge in Europe

The recommendation draws on the OASIS clinical programme and the SELECT2 trial. In the OASIS-4 study, participants lost an average of 16.6% of their body weight, with a third achieving a 20% or greater reduction – results comparable to injectable Wegovy. The label also incorporates SELECT data showing a reduction in major adverse cardiovascular events. An added practical advantage is the absence of drug-interaction restrictions, a benefit for patients on multiple medications.

Meanwhile, Eli Lilly has yet to secure a comparable EMA recommendation for an oral product, giving Novo Nordisk a significant head start in Europe. Lilly did launch its own oral obesity treatment, Foundayo, in the US in April.

US launch already gathering pace

While the European process moves forward, the oral Wegovy pill has already built substantial momentum across the Atlantic. Since launching in the US on 5 January 2026, more than 2 million prescriptions had been written by the end of April. In the week ending 17 April, weekly prescriptions exceeded 200,000. Novo Nordisk describes this as the strongest GLP-1 volume launch in US history.

Crucially, around 80% of users were new to the GLP-1 class, suggesting limited cannibalisation of injectable Wegovy. The pill generated revenue of around 2.256 billion Danish kroner (approximately $354 million) in the first quarter of 2026. Overall, the obesity business posted a 22% increase in adjusted sales at constant exchange rates in Q1.

Profit guidance still negative despite an upgrade

Despite the encouraging top-line trends, the company’s full-year outlook remains subdued. Novo Nordisk recently tightened its 2026 guidance, now forecasting a decline of 4% to 12% in both adjusted revenue and operating profit at constant exchange rates – an improvement from an earlier prediction of a 5% to 13% drop. The revised forecasts exclude the release of a 340B provision.

Headwinds include US pricing pressure and generic competition in India, Canada, Brazil and China. The company’s share buyback programme, authorising up to 15 billion Danish kroner, runs until February 2027. As of mid-May, just under 4.2 billion kroner had been deployed. Investors will be watching closely to see whether the oral Wegovy pill can deliver the growth needed to reverse the stock’s downward trajectory.