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Novo Nordisk (NVO) Down Despite Kidney Outcomes Study Success
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Novo Nordisk (NVO - Free Report) announced top-line data from the kidney outcomes study, FLOW, evaluating the efficacy of Ozempic (semaglutide) as an adjunct to standard of carefor the prevention of the progression of renal impairment in people with type II diabetes (T2D) and chronic kidney disease (CKD) compared with placebo.
Per the data readout, the FLOW outcomes study achieved its primary endpoint of a superior reduction of 24% in kidney disease progression, as well as cardiovascular and kidney death for people treated with semaglutide 1 mg against placebo, with statistical significance.
However, the company’s stock declined about 2.6% on Mar 5, as investors were expecting a higher reduction in the risk of kidney disease-related events compared with a 24% reduction in risk reported in the semaglutide 1 mg arm.
The composite primary endpoint of the study included five components measuring the progression of CKD and the risk of kidney and cardiovascular mortality. Novo Nordisk claimed that both CKD and cardiovascular components of the primary endpoint contributed to the risk reduction. Additionally, the FLOW study also met its key confirmatory secondary endpoints.
The drug was overall well-tolerated and observed a safety profile consistent with previous semaglutide 1 mg studies.
Based on the results from the FLOW outcomes study, Novo Nordisk expects to file for regulatory approvals seeking label expansion for Ozempic as an adjunctive treatment to prevent the progression of renal impairment in T2D and CKD patients in the United States and EU in 2024.
In the past year, shares of NVO have surged 73.2% compared with the industry’s 32.5% growth.
Image Source: Zacks Investment Research
The company expects to present detailed results from the FLOW outcomes study at an upcoming medical conference.
We remind the investors that in October 2023, Novo Nordisk decided to stop the FLOW outcomes study on Ozempic upon the positive recommendation of an independent data monitoring committee (DMC).
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 should be stopped at interim analysis.
Once-weekly subcutaneous diabetes injection, Ozempic, is currently approved in the United States in 0.5 mg, 1.0 mg and 2.0 mg doses for the treatment of T2D mellitus in adults, adjunct to diet and exercise. Ozempic is also approved for reducing the risk of major adverse cardiovascular events in adults with T2D mellitus and established cardiovascular disease.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has increased from 22 cents to 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has increased from 32 cents to 50 cents. Over the past year, shares of ADMA have surged 70.6%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.
In the past 30 days, the Zacks Consensus Estimate for 89Bio’s 2024 loss per share has narrowed from $2.60 to $2.36. During the same period, the estimate for 89Bio’s 2024 loss per share has narrowed from $3.08 to $2.84. In the past year, shares of ETNB have lost 10.2%.
ETNB beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average negative surprise of 1.90%.
In the past 30 days, the Zacks Consensus Estimate for Adicet Bio’s 2023 loss per share has remained constant at $3.39. During the same period, the consensus estimate for Adicet’s 2024 loss per share has narrowed from $1.97 to $1.81. In the past year, shares of ACET have plunged 70%.
ACET’s earnings beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 8.36%.
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Novo Nordisk (NVO) Down Despite Kidney Outcomes Study Success
Novo Nordisk (NVO - Free Report) announced top-line data from the kidney outcomes study, FLOW, evaluating the efficacy of Ozempic (semaglutide) as an adjunct to standard of carefor the prevention of the progression of renal impairment in people with type II diabetes (T2D) and chronic kidney disease (CKD) compared with placebo.
Per the data readout, the FLOW outcomes study achieved its primary endpoint of a superior reduction of 24% in kidney disease progression, as well as cardiovascular and kidney death for people treated with semaglutide 1 mg against placebo, with statistical significance.
However, the company’s stock declined about 2.6% on Mar 5, as investors were expecting a higher reduction in the risk of kidney disease-related events compared with a 24% reduction in risk reported in the semaglutide 1 mg arm.
The composite primary endpoint of the study included five components measuring the progression of CKD and the risk of kidney and cardiovascular mortality. Novo Nordisk claimed that both CKD and cardiovascular components of the primary endpoint contributed to the risk reduction. Additionally, the FLOW study also met its key confirmatory secondary endpoints.
The drug was overall well-tolerated and observed a safety profile consistent with previous semaglutide 1 mg studies.
Based on the results from the FLOW outcomes study, Novo Nordisk expects to file for regulatory approvals seeking label expansion for Ozempic as an adjunctive treatment to prevent the progression of renal impairment in T2D and CKD patients in the United States and EU in 2024.
In the past year, shares of NVO have surged 73.2% compared with the industry’s 32.5% growth.
Image Source: Zacks Investment Research
The company expects to present detailed results from the FLOW outcomes study at an upcoming medical conference.
We remind the investors that in October 2023, Novo Nordisk decided to stop the FLOW outcomes study on Ozempic upon the positive recommendation of an independent data monitoring committee (DMC).
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 should be stopped at interim analysis.
Once-weekly subcutaneous diabetes injection, Ozempic, is currently approved in the United States in 0.5 mg, 1.0 mg and 2.0 mg doses for the treatment of T2D mellitus in adults, adjunct to diet and exercise. Ozempic is also approved for reducing the risk of major adverse cardiovascular events in adults with T2D mellitus and established cardiovascular disease.
Novo Nordisk A/S Price and Consensus
Novo Nordisk A/S price-consensus-chart | Novo Nordisk A/S Quote
Zacks Rank and Stocks to Consider
Novo Nordisk currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industry are ADMA Biologics (ADMA - Free Report) , 89Bio (ETNB - Free Report) and Adicet Bio, Inc. (ACET - Free Report) . While ADMA sports a Zacks Rank #1 (Strong Buy), ETNB and ACET carry a Zacks Rank #2 (Buy) 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 ADMA Biologics’ 2024 earnings per share (EPS) has increased from 22 cents to 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has increased from 32 cents to 50 cents. Over the past year, shares of ADMA have surged 70.6%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.
In the past 30 days, the Zacks Consensus Estimate for 89Bio’s 2024 loss per share has narrowed from $2.60 to $2.36. During the same period, the estimate for 89Bio’s 2024 loss per share has narrowed from $3.08 to $2.84. In the past year, shares of ETNB have lost 10.2%.
ETNB beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average negative surprise of 1.90%.
In the past 30 days, the Zacks Consensus Estimate for Adicet Bio’s 2023 loss per share has remained constant at $3.39. During the same period, the consensus estimate for Adicet’s 2024 loss per share has narrowed from $1.97 to $1.81. In the past year, shares of ACET have plunged 70%.
ACET’s earnings beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 8.36%.