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Novo Nordisk (NVO) to Acquire Hypertension Drug for $1.3B
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Novo Nordisk (NVO - Free Report) announced that it will acquire the experimental drug ocedurenone, an orally administered, small-molecule, non-steroidal mineralocorticoid receptor antagonist, from KBP Biosciences for up to $1.3 billion. The acquisition will close before year-end.
Ocedurenone is currently being evaluated in the late-stage CLARION-CKD study in patients with uncontrolled hypertension and advanced chronic kidney disease (“CKD”).
The phase III CLARION-CKD study is ongoing in the United States, Europe and Asia. The study will continue as planned, with more than 600 patients expected to be randomized at more than 150 sites.
Additionally, Nordisk expects to initiate phase III trials in additional cardiovascular and kidney disease indications.
Ocedurenone has been evaluated in nine clinical trials, including the phase IIb BLOCK-CKD study, which met its primary endpoint. Ocedurenone demonstrated a clinically meaningful and statistically significant improvement in systolic blood pressure from baseline to day 84 in patients with stage 3b/4 CKD and uncontrolled hypertension in the BLOCK-CKD study. There were no reports of severe hyperkalemia or acute kidney injury.
Novo Nordisk A/S Price, Consensus and EPS Surprise
Since hypertension is a leading risk factor for cardiovascular events, heart failure, chronic kidney disease and premature death, Novo Nordisk is looking to capture ocedurenone’s best-in-class potential in treating uncontrolled hypertension and addressing cardiovascular and chronic kidney disease.
The acquisition will not impact Novo Nordisk’s operating profit outlook for 2023 or the ongoing share buy-back program.
Shares of Novo Nordisk have surged 49.5% so far this year compared with the industry’s 8.5% growth.
Shares of the company also gained last week when it announced its decision to stop the kidney outcomes study, FLOW, on Ozempic. The decision was based on the positive recommendation of an independent data monitoring committee (“DMC”).
Image Source: Zacks Investment Research
The company’s FLOW study is evaluating the efficacy of Ozempic for preventing the progression of renal impairment in people with type II diabetes and CKD compared with placebo.
The results from an interim analysis of the FLOW study data met certain pre-specified criteria for stopping the study early for efficacy. The DMC thus recommended that the study be stopped at the interim analysis. Data readout from the FLOW study is expected during the first half of 2024.
The company also upped its sales and operating profit forecast for 2023 last week due to higher demand for diabetes drug Ozempic (semaglutide) and obesity drug Wegovy.
Sales for 2023 are now projected to grow by 32-38%, up from the earlier estimate of 27-33%. Operating profit growth is now estimated at 40-46%, up from the previous 31-37% estimate.
NVO has had a tremendous run in 2023 so far due to robust uptake and positive news flow on these two drugs.
Zacks Rank and Stocks to Consider.
Novo Nordisk currently has a Zacks Rank #5 (Strong Sell).
Loss estimates for Acadia for 2023 have narrowed to 37 cents from 41 cents in the past 60 days, while earnings estimates for 2024 are pegged at 67 cents per share. Acadia’s shares have surged 49.3% so far this year.
Loss estimates for Dynavax for 2023 have narrowed to 23 cents from 51 cents in the past 90 days, while earnings estimates for 2024 are pinned at 3 cents per share. DVAX stock has surged 36% so far in 2023.
Loss estimates for Sarepta for 2023 have narrowed to $9.19 from $9.21 in the past 60 days, while loss estimates for 2024 have narrowed to $1 from $1.46.
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Novo Nordisk (NVO) to Acquire Hypertension Drug for $1.3B
Novo Nordisk (NVO - Free Report) announced that it will acquire the experimental drug ocedurenone, an orally administered, small-molecule, non-steroidal mineralocorticoid receptor antagonist, from KBP Biosciences for up to $1.3 billion. The acquisition will close before year-end.
Ocedurenone is currently being evaluated in the late-stage CLARION-CKD study in patients with uncontrolled hypertension and advanced chronic kidney disease (“CKD”).
The phase III CLARION-CKD study is ongoing in the United States, Europe and Asia. The study will continue as planned, with more than 600 patients expected to be randomized at more than 150 sites.
Additionally, Nordisk expects to initiate phase III trials in additional cardiovascular and kidney disease indications.
Ocedurenone has been evaluated in nine clinical trials, including the phase IIb BLOCK-CKD study, which met its primary endpoint. Ocedurenone demonstrated a clinically meaningful and statistically significant improvement in systolic blood pressure from baseline to day 84 in patients with stage 3b/4 CKD and uncontrolled hypertension in the BLOCK-CKD study. There were no reports of severe hyperkalemia or acute kidney injury.
Novo Nordisk A/S Price, Consensus and EPS Surprise
Novo Nordisk A/S price-consensus-eps-surprise-chart | Novo Nordisk A/S Quote
Since hypertension is a leading risk factor for cardiovascular events, heart failure, chronic kidney disease and premature death, Novo Nordisk is looking to capture ocedurenone’s best-in-class potential in treating uncontrolled hypertension and addressing cardiovascular and chronic kidney disease.
The acquisition will not impact Novo Nordisk’s operating profit outlook for 2023 or the ongoing share buy-back program.
Shares of Novo Nordisk have surged 49.5% so far this year compared with the industry’s 8.5% growth.
Shares of the company also gained last week when it announced its decision to stop the kidney outcomes study, FLOW, on Ozempic. The decision was based on the positive recommendation of an independent data monitoring committee (“DMC”).
Image Source: Zacks Investment Research
The company’s FLOW study is evaluating the efficacy of Ozempic for preventing the progression of renal impairment in people with type II diabetes and CKD compared with placebo.
The results from an interim analysis of the FLOW study data met certain pre-specified criteria for stopping the study early for efficacy. The DMC thus recommended that the study be stopped at the interim analysis. Data readout from the FLOW study is expected during the first half of 2024.
The company also upped its sales and operating profit forecast for 2023 last week due to higher demand for diabetes drug Ozempic (semaglutide) and obesity drug Wegovy.
Sales for 2023 are now projected to grow by 32-38%, up from the earlier estimate of 27-33%. Operating profit growth is now estimated at 40-46%, up from the previous 31-37% estimate.
NVO has had a tremendous run in 2023 so far due to robust uptake and positive news flow on these two drugs.
Zacks Rank and Stocks to Consider.
Novo Nordisk currently has a Zacks Rank #5 (Strong Sell).
A few better-ranked stocks in the healthcare industry are Acadia Pharmaceuticals (ACAD - Free Report) , Dynavax Technologies (DVAX - Free Report) and Sarepta Therapeutics (SRPT - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss estimates for Acadia for 2023 have narrowed to 37 cents from 41 cents in the past 60 days, while earnings estimates for 2024 are pegged at 67 cents per share. Acadia’s shares have surged 49.3% so far this year.
Loss estimates for Dynavax for 2023 have narrowed to 23 cents from 51 cents in the past 90 days, while earnings estimates for 2024 are pinned at 3 cents per share. DVAX stock has surged 36% so far in 2023.
Loss estimates for Sarepta for 2023 have narrowed to $9.19 from $9.21 in the past 60 days, while loss estimates for 2024 have narrowed to $1 from $1.46.