Novo Nordisk Pushes Three Fronts at Once as FDA Flags Eye Risk on GLP-1 Drugs

Novo Nordisk has packed an unusually dense stretch of news into a single week, spanning a fresh US label demand, a European approval, new regulatory filings and a broker upgrade — all while its share buyback keeps grinding along.

The US Food and Drug Administration on 9 November required additional warnings for GLP-1 medicines including Ozempic and Wegovy, covering a possibly elevated risk of rare vision loss linked to NAION. Novo Nordisk pushed back, stating that the available data do not establish a causal link, and reaffirmed its confidence in the benefit-risk profile of its medicines.

Brussels Clears FREHEMGO

On the other side of the Atlantic, the European Commission on Friday granted approval for FREHEMGO for the routine prevention or reduction of bleeding episodes. The green light covers adults and children with haemophilia A, with Denecimig as the active ingredient. Reuters reported that the EU clearance helped drive the stock higher on Friday, with the shares closing up 2.7%.

That same day, Novo Nordisk disclosed marketing applications for Etavopivat to both the FDA and the European Medicines Agency. The investigational, once-daily oral treatment targets sickle cell disease in patients aged twelve and older. The filings rest on results from the Phase 3 HIBISCUS study, and the company expects decisions from both regulators in 2027. Novo cited a 27% reduction in vaso-occlusive crises versus placebo. It did not attribute Friday's share price move to the filings.

Guidance Lifted After Strong Quarter

The regulatory news flow follows a guidance raise on 4 November, when Novo Nordisk lifted its full-year 2026 outlook alongside third-quarter results. It now projects adjusted sales growth at constant exchange rates of between minus 2% and plus 2%, with the same range for adjusted operating profit growth — an improvement on the previous guidance of minus 6% to 0% for both metrics.

Adjusted sales for the third quarter of 2026 came in at DKK 79.2 billion, up 4% at constant currencies. Adjusted operating profit climbed 27% to DKK 31.7 billion over the same period.

Analysts at BMO Capital responded on 5 November by raising their price target to $44 from $40, keeping a "Market Perform" rating. The broker pointed to growth of the Wegovy pill in the US but questioned whether that momentum can be sustained through 2027.

Buyback Running Toward Its Cap

Meanwhile, Novo Nordisk's existing share repurchase programme continues apace. A mandatory disclosure published on Monday showed the company had bought roughly 27.8 million B shares for about DKK 8.01 billion through 6 November. The programme carries a cap of around DKK 11.2 billion and sits within a broader twelve-month buyback of up to DKK 15 billion. The disclosure also covered repurchase transactions executed between 3 and 6 November.