Novo Nordisk’s Oral Wegovy Is the Star, but CagriSema’s FDA Verdict Looms Over the Stock

Novo Nordisk's stock recovers 44% from March lows, driven by oral Wegovy's strong launch, but faces pipeline setbacks with CagriSema and FDA scrutiny on production.

Novo Nordisk has bought back more than 11 million B-shares worth over 7.1 billion Danish kroner as part of a 12-month, 15-billion-krone programme, but the real story for investors is whether the company’s pipeline can close the 26.6% gap between the current share price and last year’s record high. The stock closed at €43.76, up 2.03% in the latest session, and has now recovered 44.64% from its March trough of €30.25.

The Danish pharma giant is navigating a tale of two product lines. On one side, the oral version of Wegovy has delivered one of the strongest product launches in the industry since hitting the market in January. More than 3 million prescriptions were written in the first five months, with roughly 80% of patients new to GLP-1 therapies entirely. That suggests the pill is expanding the addressable market rather than simply cannibalising sales from the injectable franchise. The European Commission granted marketing authorisation for the semaglutide tablet in July, paving the way for an international rollout that could provide the next leg of growth.

On the other side, the pipeline suffered a serious setback in February when CagriSema, the combination therapy positioned as Wegovy’s successor, failed to show non-inferiority against Eli Lilly’s Zepbound in the REDEFINE-4 trial. Under optimal adherence, CagriSema patients lost 23.0% of their body weight after 84 weeks, versus 25.5% for Zepbound. That gap matters because CagriSema was supposed to anchor the next phase of Novo Nordisk’s obesity franchise. The company filed for FDA approval on December 18, 2025, and a decision is expected in the fourth quarter of 2026 — a binary event that will determine whether the injectable pipeline can remain competitive.

Operational headwinds are compounding the clinical disappointment. Novo Nordisk closed its Odense production site in May, a sign of more cautious capital deployment amid shifting demand. The newly acquired Catalent plant in Bloomington, Indiana, which the company took full control of in June to boost filling capacity, received an FDA Form 483 in mid-2026 citing contamination issues and quality system deficiencies. The facility is critical to scaling up oral Wegovy supply and avoiding the shortages that have plagued the injectable version.

The competitive landscape is also turning litigious. In late July, Novo Nordisk sued Eli Lilly, accusing its rival of running misleading advertisements that compare higher Lilly dosages against lower Novo Nordisk dosages using outdated clinical data. The lawsuit lands at a time when pricing pressure in both the US and China is squeezing margins across the sector. Novo Nordisk’s management has already guided for declines in both adjusted revenue and operating profit for the full year 2026.

Technically, the stock is showing signs of stabilisation. It trades 7.81% above its 50-day moving average of €40.48 and 8.42% above the 200-day average of €40.37. The relative strength index stands at 59.1, indicating upward momentum without entering overbought territory. Options markets are pricing in an 8% swing around the August 5 second-quarter earnings release, reflecting the heightened uncertainty ahead of the numbers.

That earnings report will be the first major test since the EU approval of the Wegovy pill and the CagriSema setback. Investors will be looking for updates on prescription trends, Bloomington production ramp-up, and any changes to the CagriSema development timeline. The FDA verdict later this year remains the most consequential catalyst on the horizon — and the one most likely to determine whether Novo Nordisk can close the gap to its former highs or face another leg lower.