Novo Nordisk Keeps Buying Back Its Own Stock as Pipeline Deals and FDA Delays Shape the Story

Novo Nordisk has repurchased 21,845,000 shares for DKK 6.45bn, but the stock is down 24% this year amid a Deutsche Bank Sell rating and an FDA review delay.

Novo Nordisk is putting its money where its shares are. The Danish drugmaker disclosed the purchase of 1,225,000 B-shares between 28 September and 2 October, lifting the total under its ongoing buyback programme to 21,845,000 shares at a combined cost of DKK 6,447,270,879.

That steady accumulation comes against a bruising stretch for the stock. The shares added 1.2% on the day of the latest disclosure to close at EUR 33.45, yet they remain down 24% since the start of the year. A separate reading put the price at EUR 33.15, a 25% year-to-date decline. The pressure intensified in September, when investors used the company's capital markets day to question both its pricing power and its takeover strategy; Reuters reported the stock fell as much as 9% intraday during that session.

Deutsche Bank Stays on the Sidelines

Sentiment has not been helped by cautious calls from the sell side. On 29 September, Deutsche Bank Research reiterated a "Sell" rating with a price target of DKK 245 following its analysis of weekly prescription data, according to media reports. The downbeat stance reflects fierce competition in metabolic therapies, where rival products are eroding market share.

Regulatory friction is adding to the drag. The US Food and Drug Administration has extended its review of Denecimig, a treatment for haemophilia A, because remediation work is needed at a manufacturing site. The agency did not give a new decision date. Novo Nordisk said the delay leaves its financial guidance untouched — one source pointed to the 2026 outlook, another to the current financial year — and it still aims for a US launch in the first half of 2027. The FDA raised no concerns about the efficacy or safety data submitted, according to the company.

Licensing Spree to Broaden the Pipeline

Rather than wait for its existing blockbusters to carry the load, management is buying in outside technology. Roughly a week ago, Novo Nordisk secured worldwide rights outside Greater China to HRS-1596, an oral development candidate from Hengrui Pharma. The licensing deal carries a USD 300 million upfront payment and could reach as much as USD 2.6 billion through milestones. The stock has slipped 1.9% since that announcement.

A second, larger commitment covers use of the PharmaShell delivery system across as many as five development programmes, with payments of up to EUR 1.165 billion agreed. Together, the deals signal a willingness to spend heavily to spread future growth across multiple pillars and lock in technological capabilities early.

Clinical Data Cut Both Ways

On the science side, Novo Nordisk is working to sharpen the profile of its most important molecule. On 1 October it presented an analysis of a STEP-UP subgroup showing that 88.5% of participants on pooled injectable doses of semaglutide reached a liver fat content below 5% by week 72. Real-world data told a complementary story: in adults with type 2 diabetes, escalating to a 2 mg dose of semaglutide was linked to a 6% lower risk of major cardiovascular events than switching to tirzepatide.

Its combination candidate CagriSema also posted results. In the phase 3 REIMAGINE 5 trial, it delivered an estimated average weight reduction of 12.4%, versus 9.1% for tirzepatide. The REDEFINE 9 study showed a 21.0% drop in body weight, while the placebo arm produced little effect.

The buyback programme itself is authorised for up to DKK 15 billion. Whether that support, alongside the pipeline progress, is enough to turn the tide will hinge largely on how the pending approvals unfold.