Novo Nordisk’s Pipeline Crossroads: CagriSema, Zenagamtide and EU Wins Put Stock Under the Microscope

Novo Nordisk unveils CagriSema Phase 3 data (1.91% HbA1c drop, 14.2% weight loss) and Zenagamtide Phase 2 at ADA 2025. With stock down 37% and patent cliff approaching, pipeline results are critical.

When Novo Nordisk’s research team lands in New Orleans this week for the American Diabetes Association Scientific Sessions, they will carry more than 40 abstracts. They will carry the weight of a market desperate for proof that the Danish drugmaker’s next-generation pipeline can restore the growth story that has evaporated over the past year. The conference, running from 5 June, coincides with an investor R&D event on 7 June — a carefully timed moment for the company to make its case just months before the FDA decides on its most important new product.

The centrepiece is CagriSema, the once-weekly fixed-dose combination of semaglutide and the experimental amylin analogue cagrilintide. Novo submitted it to the US regulator in December 2025, and a decision is expected by the fourth quarter of 2026, with a launch pencilled in for early 2027. The ADA podium will offer the first full readout from the REIMAGINE Phase 3 programme in type 2 diabetes. In the REIMAGINE 2 trial, CagriSema delivered a 1.91 percentage-point reduction in HbA1c and 14.2% weight loss after 68 weeks; 43% of participants shed at least 15% of their body weight. These numbers — already teased in the filing — now face the scrutiny of the scientific community and, by extension, the investment community.

Behind CagriSema sits Zenagamtide, the GLP-1/amylin dual agonist previously known as Amycretin. Novo will present Phase 2 safety and efficacy data for both its injectable and oral formulations. Chief executive Maziar Mike Doustdar has already kicked off Phase 3 studies in obesity and related indications such as sleep apnoea and knee osteoarthritis, signalling that Zenagamtide is no longer a theoretical pipeline asset but a live programme with broad commercial ambitions. The molecule targets both weight loss and type 2 diabetes, positioning Novo to extend its franchise beyond semaglutide’s patent cliff.

That patent cliff is already casting a shadow. Semaglutide’s exclusivity is beginning to expire in a number of international markets, and Novo’s financial guidance reflects the headwinds: revenue and operating profit are expected to decline by 5% to 13% in 2026. Pricing pressure in the US — from lower realised prices, reduced Medicaid reimbursements for obesity therapies, and the Most-Favored-Nations agreement — is compounding the strain. The stock, trading at around €38.40, has recovered 9% above its 50-day moving average but remains 45% below its 52-week peak of €70.13. Year to date the shares are down 14%, while the 12-month decline stands at 37%.

Yet the company has not lost faith in its own value. Its DKK 15 billion share buyback programme continues to churn. Between 18 and 22 May, Novo purchased 1.05 million B-shares; since the programme began in February, it has bought back roughly 17 million B-shares for DKK 4.47 billion. The current sub-tranche, authorised until February 2027, has a maximum volume of DKK 11.2 billion. The buyback is a tangible vote of confidence, but it will take more than capital returns to revive the stock’s fortunes.

Regulatory tailwinds from Europe arrived last week to offer a counterpoint to the pricing gloom. The EMA’s CHMP recommended approval of Wegovy 7.2 mg as a single-dose injector, with EU launch expected in the third quarter of 2026, and also backed an oral Wegovy tablet containing 25 mg of semaglutide — the first oral GLP-1 therapy for weight loss to clear a European regulatory hurdle. Both decisions broaden Novo’s reach in the obesity market, even as the spotlight shifts to the next generation.

The data flow over the next few days will either validate the premium the market once placed on Novo’s pipeline or reinforce the scepticism that has driven the stock down from its highs. With CagriSema, Zenagamtide and the oral Wegovy tablet all in play — and with the FDA decision just months away — New Orleans has become the single most important event on Novo’s 2026 calendar.