Novo Nordisk Files Etavopivat for Sickle Cell Disease as Berenberg Stays Cautious Ahead of CagriSema

Novo Nordisk has submitted applications to both the US Food and Drug Administration and the European Medicines Agency seeking approval of Etavopivat, an investigational once-daily treatment for sickle cell disease aimed at patients aged twelve and older. The filing rests on Phase 3 data showing a 27% reduction in vaso-occlusive crises compared with placebo.

The regulatory push comes alongside a broader run of positive operational news. Novo Nordisk has now raised its full-year guidance three times, and analysts at Berenberg have reaffirmed their "Hold" rating on the stock ahead of the planned launch of CagriSema. BMO Capital Markets likewise pairs improved expectations with a neutral assessment.

Wegovy Tablet Underpins the Upgraded Guidance

The oral form of Wegovy generated quarterly revenue of DKK 5.39 billion, a rise of 53% over the prior quarter. BMO attributed its stance to that strength, noting that US sales ran 17% above consensus. The tablet launched in the US in January, and Novo Nordisk intends to bring it to more than 20 countries by mid-2027 — a rollout contingent on sufficient manufacturing capacity and the necessary approvals.

That expansion is the key test for investors: international marketing could open additional sales channels provided Novo meets the regulatory and industrial prerequisites. The planned CagriSema launch adds a further product prospect to the picture.

Third-Quarter Figures Beat Expectations

Adjusted revenue for the third quarter of 2026 came in at DKK 79.2 billion, ahead of analyst forecasts and up 4% at constant exchange rates. Adjusted operating profit reached DKK 31.7 billion, a gain of 27% at constant currencies — meaning earnings grew considerably faster than sales.

For the full year 2026, management now expects both revenue and operating profit at constant exchange rates to land somewhere between a decline of 2% and growth of 2%.

Buybacks and a Celebrity Partnership

Under its ongoing repurchase programme, which carries a total volume of up to DKK 15 billion, Novo Nordisk has bought back roughly 42.6 million B shares since the scheme began on 4 February 2026. The cumulative outlay stands at about DKK 11.8 billion as of 6 November.

The company also unveiled a partnership with DJ Khaled focused on Wegovy, centring on his weight-loss routine and his experience with the treatment.

Patent Expiries Loom Over the Longer Term

Pressure on the growth story builds further out. Core Novo Nordisk products face staggered patent expiries from 2031 onward, with Lilly among the competitors. The question for investors is whether Novo can extend the tablet's momentum beyond its current markets. The raised guidance offers operational support; a broader growth base will only emerge if the planned launches succeed.