Ocedurenone

Novo Nordisk disclosed several key updates from its cardiometabolic and hematology pipelines Wednesday as the drugmaker revealed its third-quarter profits edged out expectations. First up, the Danish pharma giant said semaglutide met the primary endpoint of a Phase 3b trial in people with peripheral arterial disease (PAD) and type 2 diabetes. At 52 weeks, 13% of people given semaglutide saw a “statistically significant” improvement in their maximum walking distance compared with placebo, according to a Wednesday release . Novo said it plans to file for approval of Ozempic in PAD in the first half of next year. Also in the diabetes space, the company’s DNA immunotherapy candidate has a safe and well-tolerated profile based on a Phase 1 test in August. The treatment is designed to preserve the body’s natural production of insulin and thus slow down or stop type 1 diabetes in people at high risk of developing it. The company has yet to spell out what it plans to do with the asset. On the hematology side, the Danish drugmaker said it is gearing up to file for approval for its hemophilia A prophylactic therapy next year. The treatment, dubbed Mim8, led to better annualized bleeding rates in a Phase 3b trial comparing it with standard-of-care emicizumab. Novo also said it terminated overall development of its mineralocorticoid receptor antagonist, named ocedurenone, after stopping a Phase 3 trial in chronic kidney disease earlier this year. The trial came to an end in June after it was deemed unable to meet its endpoints. Elsewhere, the Danish drugmaker’s Q3 performance appears to be better than Eli Lilly’s, with net profits coming in just ahead of the Wall Street consensus of DKK 27 billion ($3.9 billion). By contrast, Lilly’s total Q3 revenues of $11.4 billion missed its $12.2 billion consensus forecast. Novo’s shares $NVO rallied as much as 4% premarket Wednesday. The drugmaker narrowed its expectations for 2024 sales growth to between 23% and 27% from an original range of 22% to 28%. The revision comes after the company trimmed its guidance for profit growth in the second quarter. Both Novo and Lilly are facing competitive pressures from companies making compounded versions of their blockbuster diabetes and weight loss drugs. But Novo, during its earnings call with the media, underscored safety issues with these compounded drugs. “We have been looking at a number of compounded products in the market and identified multiple safety concerns and also noted more than 100 hospitalizations and 10 deaths based on compounded semaglutides,” CFO Karsten Munk Knudsen said. Last month, a trade group of compounding pharmacies sued the FDA for taking Eli Lilly’s tirzepatide off its shortage list despite some evidence that the drug was still in short supply.

Novo Nordisk's flagship obesity treatment Wegovy returned to forecast-topping growth in the company's latest financial results, sending shares up more than 8% on Wednesday. Sales of the GLP-1 product surged 79% in the third quarter to DKK 17.3 billion ($2.5 billion), well above consensus expectations of DKK 15.9 billion.While sales of Wegovy had grown 55% in the previous quarter to DKK 11.7 billion, they came in below consensus estimates of DKK 13.5 billion — a "blip" that Novo attributed to an adjustment of rebates related to estimates made on the prior year's revenue.And ahead of Novo's latest financial print, fears of a repeat in the third quarter had been stoked by Eli Lilly's disappointing sales figures for its competing GLP-1/GIP co-agonist products Mounjaro and Zepbound. Revenue for the two came in below analyst predictions, which Lilly blamed on inventory decreases in the US wholesaler channel. On Wednesday, Novo CEO Lars Fruergaard Jørgensen said that the pharma continues to see "very significant demand" for Wegovy in the US and is working hard to increase manufacturing capacity. However, the company warned that despite earmarking billions of dollars to invest in production, it still faces "capacity limitations" at some sites, along with "periodic supply constraints and related drug-shortage notifications."Weak diabetes sales"Wegovy continues to gain momentum and clearly exceeds expectations in the quarter," compensating for weaker diabetes sales, remarked Sydbank analyst Søren Løntoft Hansen. "This is good enough to provide some relief," added Emily Field of Barclays, explaining that Wegovy's beat came despite slightly worse pricing in the US than anticipated.Novo's overall sales and profit both increased 21% in the third quarter to DKK 71.3 billion and DKK 27.3 billion, respectively. However, the revenue figure came in below analyst projections of DKK 72.3 billion, partly due to lacklustre growth in its diabetes segment, including for Ozempic.In the quarter, Ozempic — which contains the same active ingredient as Wegovy — generated sales of DKK 29.8 billion, up 26% year-over-year at constant currencies, but below forecasts of DKK 30.5 billion.Guidance narrowedFor the full year, Novo said it now expects sales growth of between 23% and 27% on a constant exchange rate basis, narrowed from a prior range of 22% to 28%. Meanwhile, operating profit growth was similarly revised, and is now seen between 21% and 27%, from previous guidance of 20% to 28%.Investors had feared the drugmaker would cut its outlook, noted Terence McManus of Bellevue Asset Management. "However, we don't see these results as an all-clear signal on the stock," he added, with all eyes now set to turn to pending late-stage data for its next obesity hopeful dubbed CagriSema.The therapy, which combines semaglutide — the active ingredient in Ozempic and Wegovy — with the amylin analogue cagrilintide, is expected to lead to weight loss of over 15% when results are unveiled later this year. Martin Holst Lange, Novo's development head, reaffirmed that CagriSema has potential for up to 25% weight loss, with "no change in our confidence level."Other pipeline updatesNovo also disclosed alongside its financial print that the Phase IIIb STRIDE study of Ozempic as an adjunct to standard of care in people with type 2 diabetes and peripheral arterial disease with intermittent claudication met its primary endpoint. The drug demonstrated a clinically relevant and statistically significant improvement in maximum walking distance of 13% compared to placebo. US and EU marketing applications in this indication are targeted for the first half of 2025.Additionally, the company plans regulatory filings next year for its factor VIIIa mimetic bispecific antibody Mim8 in haemophilia A. Following up on the positive Phase IIIa FRONTIER 2 trial, Novo said Wednesday that the Phase IIIb FRONTIER 5 study has now been completed. The trial assessed switching from prophylaxis with Roche's once-weekly therapy Hemlibra (emicizumab) to Mim8 — something Novo reported was well tolerated.Elsewhere, Novo said it has now decided to bin development of the non-steroidal mineralocorticoid receptor antagonist ocedurenone across all indications. The future of the asset — gained from KBP Biosciences for up to $1.3 billion — was under review following the failure in June of the Phase III CLARION-CKD study in patients with uncontrolled hypertension and advanced chronic kidney disease.($1 = DKK 6.92889)