Novo Nordisk on Friday reported disappointing results in late-stage trials of its experimental next-generation obesity drug Caigrisema, leading to a loss of more than $125 billion. market value,
A Danish company’s successor ambitions have been dealt a blow after its drug candidate weighed less than expected. vegovi weight loss medicine It is more powerful than Eli Lilly’s rival Zepbound, also known as Monjaro.
Investors and analysts were eagerly awaiting this data as a test of Novo’s case strong pipeline of medicines Following Wegovi into the highly competitive anti-obesity market.
The Cagrisema trial showed the drug helped patients lose 22.7% of their weight, which was 25% less than Novo Nordisk expected.
Novo shares fell as much as 27% after the results were announced, one of the biggest one-day wipeouts on record for a European company since August 2023. Denmark-listed shares of the stock closed down 21% on Friday.
Shares of U.S. rival Lilly rose 2%.
‘worst case scenario’
Novo said that if everyone followed treatment with Caigrisema, overall patients lost 22.7% of their weight after 68 weeks, while 40.4% lost 25% or more.
Cagrisema is a weekly injection that combines semaglutide, which is the active ingredient in Vegovy and mimics the gut hormone GLP-1, and a different molecule called cagrilintide that mimics the pancreatic hormone amylin.
Both hormones together suppress appetite and help control patients’ blood sugar.
Marcus Mans, portfolio manager at mutual fund firm Union Investment, a shareholder of Novo and Lilly, said the results are a “worst-case scenario” for Novo.
“Cagrissema is just as good as Zepbound, but more complicated to manufacture,” he said.
Lilly’s own obesity injection – sold in the United States as Zepbound – led to an average weight loss of about 23% in clinical trials.
Data from Novo’s Caigrisema Phase III trial were based on about 3,400 people who had a body mass index (BMI) of 30 or higher or people who had a BMI of 27 and at least one weight-related co-morbidity such as high blood pressure or heart disease. There was a disease.
Investor Mains said Novo management should have set more conservative goals, such as a higher weight loss target than Wegovi or similar to Zepbound.
“Predicting the outcomes of Phase 3 is more art than science. However, I think it was a strategic mistake to set expectations so high,” he said.
new test
Martin Holst Lange, Novo Nordisk’s executive vice president of development, said Novo was “encouraged” by the data.
He said only 57% of patients in the trial reached the highest dose.
Alexander Jencke, portfolio manager of Medical Strategy in Munich and Novo shareholder, said this would indicate there were issues regarding tolerability among some patients.
They said rates of gastrointestinal adverse events such as nausea, vomiting and diarrhea may be higher.
Nordea analyst Michael Novod said patients may have stopped the injections after achieving satisfactory weight loss.
Although the test did not meet expectations, the serious reaction to the share price is over, Novod said.
“Despite the disappointing results, cagrisema is still the best weight loss candidate in the phase 3 trial,” he said.
Investors noted that when the two other patient groups in the trial were given either only cagrilintide or semaglutide, a much higher percentage of patients achieved the highest dose: 83% for the cagrilintide arm and 70% for semaglutide.
The company did not immediately respond to a request for comment on why more patients did not reach the highest dose.
Novo said in its statement that the drug has similar side effects compared to its GLP-1 drugs already on the market.
The most common adverse events with CAGRISEMA were gastrointestinal, and the vast majority were mild to moderate and decreased over time, consistent with the GLP-1 receptor agonist class.
Novo Nordisk plans to start a new trial in the first half of next year to explore the additional weight loss potential of Caigrisema, a Novo Nordisk spokesperson said.
It hopes to submit the drug for regulatory approval by the end of 2025.
Ahead of trial results, analysts estimate peak sales for Cagrisema could be $20 billion.
most advanced
Novo’s trial is the most advanced amylin drug candidate currently being tested on the market.
Shares of Danish drugmaker Zealand Pharma, which is testing a weight-loss drug that also mimics the pancreatic hormone amylin, after the data fell,
Wegovi’s success helped make Novo Europe’s largest company by market capitalization, worth more than $460 billion.
Some analysts estimate that the obesity drug market could be worth approximately $150 billion per year globally by the early 2030s.
However, concerns that Novo could lose its first-mover advantage in the obesity drug race have sent its shares tumbling this year.
Pressure to find a more powerful successor to Wegovi increased when Lilly published data from a late-stage trial in early December that pitted its ZepBound against Wegovi and showed that ZepBound was more effective.
