Novo Nordisk Fires on All Cylinders: Haemophilia Approval, Raised Guidance and a Buyback in Full Swing

Novo Nordisk closed out a hectic week with its shares up 2.7% on Friday, a move Reuters attributed to the European Commission's green light for FREHEMGO in haemophilia A. The approval, granted the same day, covers routine prophylaxis to prevent or reduce bleeding episodes in adults and children with the condition, including those with inhibitors. The active ingredient is denecimig, and the Danish group plans once-monthly, biweekly or weekly dosing, with first European launches earmarked for next year.

The regulatory news flow did not stop there. Novo also confirmed Friday that it has filed for approval of Etavopivat with both the US Food and Drug Administration and the European Medicines Agency. The investigational oral therapy, taken once daily, is aimed at people aged twelve and over living with sickle cell disease.

FDA Adds Eye-Risk Language to GLP-1 Labels

On the other side of the Atlantic, the FDA on 9 November requested additional warnings for GLP-1 medicines, Ozempic and Wegovy among them, over a possible elevated risk of rare vision loss linked to NAION. Novo pushed back, saying the available data do not establish a causal relationship, and reiterated its confidence in the benefit-risk profile of its products.

Early Responders Shed a Quarter of Their Body Weight

Alongside the regulatory headlines, Novo used ObesityWeek to roll out further post-hoc analyses of the Phase 3 REDEFINE 1 trial of CagriSema, which has yet to secure approval. One cut of the data showed that 73.1% of treated patients recorded a meaningful improvement in physical function, against 49.1% on placebo. A second analysis focused on adults who responded early to the drug — a group making up 67.8% of those treated, according to the company. Those early responders averaged a 25.4% reduction in body weight after 68 weeks.

Guidance Lifted as Third-Quarter Profit Jumps

The pipeline and label developments sit on top of a stronger financial base. When Novo reported third-quarter and nine-month 2026 results on 4 November, adjusted operating profit for the quarter beat expectations, according to Reuters, and management raised its full-year revenue and earnings outlook. Adjusted revenue growth at constant currencies is now guided to a range of minus 2% to plus 2%, with the same band applied to adjusted operating profit — both lifted from the previous forecast of minus 6% to 0%.

The quarterly numbers behind that upgrade were solid. Adjusted revenue came in at DKK 79.2 billion, up 4% at constant exchange rates, while adjusted operating profit climbed 27% to DKK 31.7 billion.

Buyback Passes the DKK 11.8 Billion Mark

Shareholder returns are running in parallel. In a 9 November update on its existing repurchase programme, Novo said it had bought back roughly 42.6 million B shares since 4 February, for a total of about DKK 11.8 billion, as of 6 November. The programme authorises up to DKK 15 billion over twelve months, leaving room for further purchases.