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NOVO NORDISK: EXTENDED STUDIES FOR THE OBESITY CANDIDATE CAGRISEMA
STOCKHOLM (Nyhetsbyrån Direkt) The Danish pharmaceutical company Novo Nordisk is broadening, after last year’s study failure in December, the studies on the obesity drug candidate cagrisema.
This was stated by Novo Nordisk CEO Lars Fruergaard Jørgensen during a telephone conference on Wednesday.
This involves an evaluation of cagrisema during an extended treatment period - 80 weeks instead of 68 weeks - and to determine whether dose increases can provide improved weight loss. In addition, a change is being made in the comparative study between cagrisema and competitor Eli Lilly’s obesity drug Zepbound (tirzepatid). The study period in the comparative study is being extended to 84 weeks.
The study, called Redefine 11, with an extended study period and dose increases, is expected to begin in the second quarter of 2025.
Results from the comparative study Redefine 4 are now expected to be read out in 2026. The study will also have a flexible protocol and will now last for 84 weeks instead of the previous information of a 72-week treatment period. According to the previous assessment, the study would have a primary completion (primary completion) at the end of August 2025 followed by an estimated completion (study completion) in early October 2025.
Novo Nordisk is following its plan to submit an application for marketing approval for cagrisema in the first quarter of 2026.
Just before Christmas 2024, Novo Nordisk presented overall results for cagrisema in phase 3. Although the primary goal of the study was achieved with an average weight loss of almost 23 percent after 68 weeks of treatment, the weight loss was still less than expected. Both analysts and Novo Nordisk themselves had spoken of weight reductions of at least 25 percent before the study. The study miss caused Novo Nordisk’s share price to plummet by 21 percent on December 20, 2024.
Novo shares defy downgrade: JPMorgan sees price weakness as buying opportunity
With a rise of 5.2 percent to DKK 464, Novo Nordisk on Wednesday defied a rather weak financial report measured by sales in the important weight loss business and a downward revision of expectations.
The pharmaceutical giant has lowered its expectations for sales and operating income, citing lower-than-expected growth in sales of GLP-1 drugs in the US due to sales of copycat products from so-called “compounders” who make imitations and their own versions of Novo’s drugs.
The shares have been under severe pressure since their peak of over DKK 1,000 in June last year, and analyst Richard Vosser from JPMorgan also believes that the downward revision was already factored into the price.
JPMorgan’s analyst, who has a positive “overweight” recommendation on the stock, sees any weakness in the share price today as a buying opportunity “ahead of the potential to improve sales growth of the weight loss treatment Wegovy as the so-called “compounders” exit the US market.”
Novo Nordisk’s sales of weight loss drugs rose by 67 percent in the first quarter measured in DKK, but analysts had turned up their noses after an increase of as much as 81 percent.
Novo lowers expectations and now sees growth in sales in local currencies of 13-21 percent compared to previously expected 16-24 percent, while operating profit is expected to increase by 16-24 percent compared to previously expected 19-27 percent.
NOVO NORDISK: CVS HEALTH ANNOUNCEMENT NOT LINKED TO PRICE - CEO
STOCKHOLM (Nyhetsbyrån Direkt) The decision by the American pharmacy chain CVS Health to remove Eli Lilly’s obesity drug Zepbound as the preferred option in favor of the Danish pharmaceutical company Novo Nordisk’s drugs Wegovy and Saxenda is not about a price issue.
“It is not a price decision because we did not give any exclusive offer based on a low price,” said Novo Nordisk CEO Lars Fruergaard Jørgensen during a conference call on Wednesday.
The decision was also not made on Novo Nordisk’s initiative.
“We did not ask for exclusive access at CVS,” said Lars Fruergaard Jørgensen, adding that the decision was made by CVS Health.
The Novo Nordisk boss assumes that CVS Health’s decision is instead based on the properties of the drug Wegovy with “a strong cardiovascular protective profile.”
Furthermore, the ongoing evaluation of Wegovy in the treatment of fatty liver, so-called MASH, is believed to have played a role in the decision, according to Lars Fruergaard Jørgensen.
Given that Novo Nordisk has so far only reached a small part of the obesity market, it is about growing the market rather than taking market share in the short term, according to the Novo Nordisk CEO.
NOVO NORDISK: SEMAGLUTIDE IS ON THE WAY TO BE THE FIRST ORAL GLP-1 TREATMENT IN THE USA
STOCKHOLM (Nyhetsbyrån Direkt) The Danish pharmaceutical company Novo Nordisk estimates that semaglutide will be the first to enter the US market for oral obesity treatments in the GLP-1 drug class.
Novo Nordisk CEO Lars Fruergaard Jørgensen said this during a conference call on Wednesday.
In February 2025, the company submitted a marketing application in the US to the US Food and Drug Administration (FDA).
Novo Nordisk CEO emphasizes that the manufacturing of the drug will take place in the US, both in terms of the active ingredient, tablets and packaging.
In the Oasis 4 study, oral semaglutide showed an average weight loss of almost 17 percent. The corresponding weight loss for patients who received placebo was just under 3 percent.
The conference call presentation also shows that approximately 30 percent of patients in the study in question achieved a weight loss of more than 20 percent.
In the secondary objectives of the aforementioned study, oral semaglutide showed benefits in terms of cardiovascular risk factors (cardiometabolic risk) as well as physical function.
