By Maggie Fick and Jacob Gronholt-Pedersen
LONDON/COPENHAGEN (Reuters) -Novo Nordisk on Friday revealed disappointing leads to a late-stage trial for its experimental next-generation weight problems drug CagriSema, wiping as a lot as $125 billion off its market worth.
The lower-than-expected weight reduction from the drug candidate offers a blow to the Danish firm’s ambitions for a successor to its Wegovy weight-loss drug that’s extra highly effective than Eli Lilly (NYSE:)’s rival Zepbound, also called Mounjaro.
Buyers and analysts had eagerly awaited this knowledge as a take a look at of Novo’s case that it has a powerful pipeline of medication to comply with Wegovy within the fiercely aggressive anti-obesity market.
The CagriSema trial confirmed the drug helped sufferers reduce their weight by 22.7%, beneath the 25% Novo Nordisk (NYSE:) had anticipated.
Novo’s shares fell as a lot as 27% after the outcomes had been introduced, hitting their lowest since August 2023 in one of many greatest one-day wipe outs on document for a European firm. They had been down 18.8% at 1225 GMT.
Shares in U.S. rival Lilly rose greater than 7% in pre-market commerce.
‘WORST CASE SCENARIO’
Novo stated if all individuals adhered to remedy with CagriSema, sufferers total achieved weight lack of 22.7% after 68 weeks, with 40.4% shedding 25% or extra.
CagriSema is a weekly injection combining semaglutide, which is the energetic ingredient in Wegovy and mimics the intestine hormone GLP-1, and a separate molecule known as cagrilintide that mimics the pancreatic hormone amylin.
The 2 hormones mixed suppress starvation and assist management sufferers’ blood glucose.
The outcomes are a “worst case-scenario” for Novo, stated Markus Manns, portfolio supervisor at mutual funds agency Union Funding, a Novo and Lilly shareholder.
“CagrisSema is only as good as Zepbound, but more complex to manufacture,” he stated.
Lilly’s personal weight problems injection – bought as Zepbound in the USA – led to a median weight lack of practically 23% in scientific trials.
The info from Novo’s CagriSema Section III trial was based mostly on about 3,400 individuals with a physique mass index (BMI) of 30 or above or individuals with a BMI of 27 and not less than one weight-related comorbidity like hypertension or heart problems.
NEW TRIAL
Martin Holst Lange, Novo Nordisk’s govt vice chairman for improvement, stated Novo was “encouraged” by the information.
He stated solely 57% of sufferers within the trial reached the very best dose.
Alexander Jenke, a portfolio supervisor at Medical (TASE:) Technique in Munich, and a Novo shareholder, stated this is able to point out that there have been points concerning tolerability amongst some sufferers.
He stated there might have been increased charges of gatrointestinal opposed occasions akin to nausea, vomiting, and diarrhea.
Nordea analyst Michael Novod stated sufferers might have stopped the injections after hitting a passable weight reduction.
Whereas the trial missed expectations, the extreme share worth response is overdone, Novod stated.
“Despite the disappointing results, CagriSema is still the best weight loss reported in a Phase 3 trial,” he stated.
Buyers famous that the 2 different affected person teams within the trial which had been both given solely cagrilintide or semaglutide, a lot increased percentages of sufferers reached the very best dose: 83% for the cagrilintide arm and 70% for semaglutide.
The corporate didn’t instantly reply to a request for touch upon why extra sufferers didn’t attain the very best dose.
Novo stated in its assertion the drug had comparable uncomfortable side effects in contrast with its GLP-1 medication already in the marketplace. The commonest opposed occasions with CagriSema had been gastrointestinal, and the overwhelming majority had been gentle to reasonable and diminished over time, per the GLP-1 receptor agonist class, it stated.
Novo Nordisk plans to begin a brand new trial within the first half of subsequent yr to additional discover CagriSema’s further weight-loss potential, a Novo Nordisk spokesperson stated.
It expects to submit the drug for regulatory approval in the direction of the tip of 2025.
MOST ADVANCED
Novo’s trial is probably the most superior for an amylin drug candidate at present being examined out there.
The success of Wegovy helped make Novo Europe’s greatest firm by market capitalisation, price greater than $460 billion.
Its shares have been underneath stress this yr, nevertheless, considerably underperforming these of chief rival Lilly, due primarily to considerations Novo could also be shedding its first-mover benefit within the weight problems drug race.
Simon Baker, head of worldwide biopharma analysis at Redburn Atlantic in London, stated CagriSema with a 23% weight-loss consequence should still be commercially viable in the long term.
“The 27% drop (in the share price) is completely out of proportion fundamentally, but positioning around this event was huge and it will take a while for this to stabilise,” he stated.
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