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Novo Nordisk's (NVO) Phase III Diabetes Study Meets Primary Goal
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Novo Nordisk A/S (NVO - Free Report) announced positive top-line results from its late-stage COMBINE 3 study evaluating once-weekly IcoSema in 679 people with type II diabetes inadequately controlled on daily basal insulin.
The company’s investigational candidate, IcoSema, is a fixed-ratio combination of basal insulin icodec and semaglutide.
The 52-week phase IIIa COMBINE 3 study is comparing the efficacy and safety of once-weekly IcoSema against once-daily insulin glargine U100 and insulin aspart (injected two to four times a day during mealtimes).
Per the data readout, the COMBINE 3 study achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 52 with once-weekly IcoSema compared with insulin glargine U100 and insulin aspart.
In the study, the overall baseline HbA1c is 8.3%. Patients treated with once-weekly IcoSema achieved an estimated reduction in HbA1c of -1.47 percentage points compared with -1.40 percentage points for insulin glargine U100 and insulin aspart.
Additionally, it was observed that patients treated with IcoSema achieved a superior reduction in the estimated change of body weight (weight loss of 3.6 kg) compared with a weight gain (3.2 kg) observed in patients receiving insulin glargine U100 and insulin aspart.
Over the past year, shares of Novo Nordisk have jumped 59.6% compared with the industry’s 13.4% rise.
Image Source: Zacks Investment Research
The COMBINE 3 study also witnessed the superiority of IcoSema over insulin glargine U100 and insulin aspart in estimated rates of severe or clinically significant (blood glucose below 3 mmol/L) hypoglycaemia.
In the study, treatment with IcoSema was found to be safe and overall well-tolerated. Common adverse events observed in the study upon treatment with IcoSema were gastrointestinal, which were mild to moderate in severity.
IcoSema reduces the injection burden to a single injection per week compared with around 28 injections per week for people with type II diabetes inadequately controlled on basal insulin while providing glycaemic control as well as weight benefits and lower rates of hypoglycaemia.
The COMBINE 3 study is one of the three studies that is currently ongoing under the phase IIIa COMBINE program evaluating IcoSema.
The COMBINE 1 study is evaluating the candidate’s efficacy and safety in patients with type II diabetes inadequately controlled on basal insulin treatment compared with treatment with insulin icodec.
On the other hand, the COMBINE 2 study is evaluating IcoSema’s efficacy and safety in approximately 700 people with type II diabetes inadequately controlled on GLP-1 treatment compared with treatment with semaglutide 1.0 mg.
We remind the investors that Novo Nordisk already markets once-weekly subcutaneous semaglutide (0.5, 1.0 and 2.0 mg doses) under the brand name Ozempic. The drug is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type II diabetes mellitus and reduce the risk of major adverse cardiovascular events in adults with type II diabetes mellitus and established cardiovascular disease.
Novo Nordisk also markets Wegovy (semaglutide 2.4 mg) for chronic weight management in adults with obesity or overweight. The drug received FDA approval in 2021 and has been witnessing solid uptake ever since, driven by increasing demand worldwide.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has increased from 72 cents to 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 64 cents to 69 cents. Over the past year, shares of PBYI have gained 1.3%.
PBYI beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 3 cents to 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 18 cents. Over the past year, shares of ADMA have gained 31.5%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Acadia’s 2023 loss per share has remained constant at 33 cents. During the same time frame, the consensus estimate for Acadia’s 2024 EPS is pegged at $1.04. Over the past year, shares of ACAD have rallied 74.3%.
ACAD beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average earnings surprise of 20.69%.
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Novo Nordisk's (NVO) Phase III Diabetes Study Meets Primary Goal
Novo Nordisk A/S (NVO - Free Report) announced positive top-line results from its late-stage COMBINE 3 study evaluating once-weekly IcoSema in 679 people with type II diabetes inadequately controlled on daily basal insulin.
The company’s investigational candidate, IcoSema, is a fixed-ratio combination of basal insulin icodec and semaglutide.
The 52-week phase IIIa COMBINE 3 study is comparing the efficacy and safety of once-weekly IcoSema against once-daily insulin glargine U100 and insulin aspart (injected two to four times a day during mealtimes).
Per the data readout, the COMBINE 3 study achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 52 with once-weekly IcoSema compared with insulin glargine U100 and insulin aspart.
In the study, the overall baseline HbA1c is 8.3%. Patients treated with once-weekly IcoSema achieved an estimated reduction in HbA1c of -1.47 percentage points compared with -1.40 percentage points for insulin glargine U100 and insulin aspart.
Additionally, it was observed that patients treated with IcoSema achieved a superior reduction in the estimated change of body weight (weight loss of 3.6 kg) compared with a weight gain (3.2 kg) observed in patients receiving insulin glargine U100 and insulin aspart.
Over the past year, shares of Novo Nordisk have jumped 59.6% compared with the industry’s 13.4% rise.
Image Source: Zacks Investment Research
The COMBINE 3 study also witnessed the superiority of IcoSema over insulin glargine U100 and insulin aspart in estimated rates of severe or clinically significant (blood glucose below 3 mmol/L) hypoglycaemia.
In the study, treatment with IcoSema was found to be safe and overall well-tolerated. Common adverse events observed in the study upon treatment with IcoSema were gastrointestinal, which were mild to moderate in severity.
IcoSema reduces the injection burden to a single injection per week compared with around 28 injections per week for people with type II diabetes inadequately controlled on basal insulin while providing glycaemic control as well as weight benefits and lower rates of hypoglycaemia.
The COMBINE 3 study is one of the three studies that is currently ongoing under the phase IIIa COMBINE program evaluating IcoSema.
The COMBINE 1 study is evaluating the candidate’s efficacy and safety in patients with type II diabetes inadequately controlled on basal insulin treatment compared with treatment with insulin icodec.
On the other hand, the COMBINE 2 study is evaluating IcoSema’s efficacy and safety in approximately 700 people with type II diabetes inadequately controlled on GLP-1 treatment compared with treatment with semaglutide 1.0 mg.
We remind the investors that Novo Nordisk already markets once-weekly subcutaneous semaglutide (0.5, 1.0 and 2.0 mg doses) under the brand name Ozempic. The drug is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type II diabetes mellitus and reduce the risk of major adverse cardiovascular events in adults with type II diabetes mellitus and established cardiovascular disease.
Novo Nordisk also markets Wegovy (semaglutide 2.4 mg) for chronic weight management in adults with obesity or overweight. The drug received FDA approval in 2021 and has been witnessing solid uptake ever since, driven by increasing demand worldwide.
Novo Nordisk A/S Price and Consensus
Novo Nordisk A/S price-consensus-chart | Novo Nordisk A/S Quote
Zacks Rank & Other Stocks to Consider
Novo Nordisk currently carries a Zacks Rank #2 (Buy).
Some other top-ranked drug/biotech stocks are Puma Biotechnology, Inc. (PBYI - Free Report) , ADMA Biologics (ADMA - Free Report) and Acadia Pharmaceuticals (ACAD - Free Report) . PBYI sports a Zacks Rank #1 (Strong Buy), and ADMA and ACAD carry a Zacks Rank #2 each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has increased from 72 cents to 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 64 cents to 69 cents. Over the past year, shares of PBYI have gained 1.3%.
PBYI beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 3 cents to 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 18 cents. Over the past year, shares of ADMA have gained 31.5%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Acadia’s 2023 loss per share has remained constant at 33 cents. During the same time frame, the consensus estimate for Acadia’s 2024 EPS is pegged at $1.04. Over the past year, shares of ACAD have rallied 74.3%.
ACAD beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average earnings surprise of 20.69%.