Novo Nordisk’s Wegovy Portfolio Doubles Down: EU Regulators Back 7.2mg Pen and Oral Pill as Shares Slump
22.05.2026 - 21:43:11 | boerse-global.de
The Danish drugmaker has secured a pair of pivotal regulatory endorsements from European medicines authorities within days, yet its stock remains mired in a prolonged downturn. A committee of the European Medicines Agency recommended approval for a higher-dose single-injection Wegovy pen, while the EMA itself separately backed the oral version of the drug. The twin green lights underscore Novo Nordisk’s push to dominate the obesity market with multiple formulations, but investors are still fixated on pricing pressure, rising competition, and shrinking margins.
The CHMP’s recommendation for the Wegovy 7.2 mg single-dose pen addresses a clear patient need: previously, those requiring a weekly dose of that strength had to self-administer three shots of the 2.4 mg variant. The new pen cuts that to a single injection, a convenience that could improve treatment adherence. The recommendation is based on the STEP UP clinical programme, which showed a mean weight loss of 20.7% in the main study, with roughly one-third of participants shedding at least a quarter of their starting weight. For patients with type 2 diabetes, the average loss reached 14.1%. The safety profile was consistent with earlier semaglutide trials. Novo Nordisk plans to launch the pen in the European Union in the third quarter of 2026, following its existing approval as Wegovy HD in the United States and Britain.
On the oral front, the EMA issued a positive opinion for the first oral obesity treatment in Europe — a Wegovy pill that is already on the market in the US. The final decision now rests with the European Commission, which typically rules within 67 days of the agency’s recommendation. Outside the US, Novo Nordisk expects to introduce the oral formulation in the second half of 2026, provided the regulatory nod comes through. In America, where the pill launched on 5 January, the company reported more than 200,000 weekly prescriptions for the week ending 17 April and cumulative prescriptions exceeding 2 million. The oral Wegovy generated 2.256 billion Danish kroner in first-quarter revenue.
Should investors sell immediately? Or is it worth buying Novo Nordisk?
The regulatory progress arrives against a backdrop of mixed quarterly results. Revenue from obesity treatments, adjusted for currency effects, jumped 22% in the first quarter. Yet total group revenue fell 4%, and adjusted operating income dropped 6%. The divergence reflects lower realised pricing on GLP-1 products even as volumes swell, a pattern that has weighed heavily on the stock. Novo Nordisk’s shares changed hands at 38.64 euros on Friday, a gain of just under 1% for the session, but that does little to mask a grim longer view. The stock has lost roughly 36% over the past twelve months and sits about 45% below its 52-week peak of more than 70 euros. Year to date, the decline stands at around 15%.
Management has responded by lifting its full-year guidance, though the outlook remains cautious. The company now expects adjusted revenue to shrink between 4% and 12% in 2026, with adjusted operating profit suffering a similar contraction — both at constant exchange rates and excluding the release of a 340B reserve. The message is clear: Novo Nordisk is banking on volume growth to offset relentless pricing headwinds, but the margin squeeze shows no sign of easing.
Adding to the pressure, Eli Lilly introduced its own oral obesity tablet, Foundayo, in the US in April, intensifying a battle that is already reshaping the GLP-1 landscape. While the two regulatory milestones broaden Novo Nordisk’s arsenal — including the existing injectable, the new 7.2 mg pen, and the oral pill — the hard work of commercialisation lies ahead. In Europe, each national health system will need to negotiate reimbursement, and the pace of physician adoption remains uncertain.
The regulatory wins are undeniably positive for the pipeline, but they have not yet moved the needle for a shareholder base that has been burned by falling margins and intensifying competition. For Novo Nordisk, the next critical test will be whether the convenience and novelty of these new formats can translate into higher prescription volumes and, ultimately, stabilise pricing power. The door has been opened; the real battle begins on the other side.
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