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Akebia (AKBA) Up as Vafseo Gets FDA Nod for Anemia Due to CKD
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Akebia Therapeutics, Inc. (AKBA - Free Report) announced that the FDA has approved its Vafseo (vadadustat) tablets for the treatment of anemia due to chronic kidney disease (CKD). The eligible patient population for treatment with the drug includes adults who have been receiving dialysis for at least three months.
The approval of Vafseo tablets gives Akebia its second FDA-approved product, after Auryxia (ferric citrate), which is indicated for thecontrol of serum phosphorus levels in adult patients with CKD on dialysis. Vafseo is a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor that is now approved in 37 countries, including the United States.
The oral method of the use of Vafseo tablets makes it an easier-to-use medicine compared with currently injectable erythropoiesis-stimulating agents that are mostly administered at dialysis centers to treat anemia in CKD patients.
The stock has been gaining in the premarket hours on Mar 28, as the investors are impressed by the FDA approval of Vafseo.
In the past year, shares of AKBA have skyrocketed 270.2% against the industry’s 5.8% decline.
Image Source: Zacks Investment Research
However, it is important to note that the label of Vafseo tablets includes a boxed warning regarding increased risk of death, myocardial infarction, stroke, venous thromboembolism and thrombosis of vascular access. Under limitations of use, the label also reads that the drug has not been shown to improve quality of life, fatigue or patient well-being.
The FDA approval of Vafseo for the CKD indication is based on efficacy and safety data from the phase III INNO2VATE program and an assessment of post-marketing safety data from Japan, where the drug was launched in August 2020.
Management believes that treatment with the drug will provide additional therapeutic benefits, effectively increasing and maintaining hemoglobin concentrations within guideline-recommended target ranges for patients receiving maintenance dialysis over current standard-of-care therapy.
Akebia is currently gearing up to utilize its own deep renal experience as well as leverage its partnership with CSL Vifor to commercialize Vafseo in the United States. CSL Vifor is an industry leader in bringing innovative therapies to U.S. dialysis organizations.
The company expects to execute its launch strategy in such a way that will potentially bolster Vafseo as a new oral standard of care for adult dialysis patients.
Per Akebia, an estimated 500,000 adult patients in the United States on dialysis suffer from anemia due to CKD, which often causes further complications in patients. Anemia is a blood disorder in which the human body cannot produce enough healthy red blood cells to carry adequate oxygen to the body's tissues.
CKD patients are prone to anemia because their kidneys do not produce enough erythropoietin, a hormone that helps regulate the production of red blood cells. Symptoms of anemia due to CKD include fatigue, dizziness, shortness of breath and cognitive dysfunction, which can lead to deterioration in health and even death if left untreated.
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. In the past year, shares of ADMA have surged 106.4%.
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 FibroGen’s 2024 loss per share has narrowed from $1.14 to $1.09. During the same period, the estimate for FibroGen’s 2025 loss per share is pegged at 6 cents. In the past year, shares of FGEN have plunged 86.7%.
FGEN beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 2.26%.
In the past 30 days, the Zacks Consensus Estimate for Adicet Bio’s 2024 loss per share has narrowed from $1.81 to $1.72. During the same period, the consensus estimate for Adicet’s 2025 loss per share has narrowed from $1.87 to $1.84. In the past year, shares of ACET have plunged 61.5%.
ACET beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average negative surprise of 0.17%.
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Akebia (AKBA) Up as Vafseo Gets FDA Nod for Anemia Due to CKD
Akebia Therapeutics, Inc. (AKBA - Free Report) announced that the FDA has approved its Vafseo (vadadustat) tablets for the treatment of anemia due to chronic kidney disease (CKD). The eligible patient population for treatment with the drug includes adults who have been receiving dialysis for at least three months.
The approval of Vafseo tablets gives Akebia its second FDA-approved product, after Auryxia (ferric citrate), which is indicated for thecontrol of serum phosphorus levels in adult patients with CKD on dialysis. Vafseo is a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor that is now approved in 37 countries, including the United States.
The oral method of the use of Vafseo tablets makes it an easier-to-use medicine compared with currently injectable erythropoiesis-stimulating agents that are mostly administered at dialysis centers to treat anemia in CKD patients.
The stock has been gaining in the premarket hours on Mar 28, as the investors are impressed by the FDA approval of Vafseo.
In the past year, shares of AKBA have skyrocketed 270.2% against the industry’s 5.8% decline.
Image Source: Zacks Investment Research
However, it is important to note that the label of Vafseo tablets includes a boxed warning regarding increased risk of death, myocardial infarction, stroke, venous thromboembolism and thrombosis of vascular access. Under limitations of use, the label also reads that the drug has not been shown to improve quality of life, fatigue or patient well-being.
The FDA approval of Vafseo for the CKD indication is based on efficacy and safety data from the phase III INNO2VATE program and an assessment of post-marketing safety data from Japan, where the drug was launched in August 2020.
Management believes that treatment with the drug will provide additional therapeutic benefits, effectively increasing and maintaining hemoglobin concentrations within guideline-recommended target ranges for patients receiving maintenance dialysis over current standard-of-care therapy.
Akebia is currently gearing up to utilize its own deep renal experience as well as leverage its partnership with CSL Vifor to commercialize Vafseo in the United States. CSL Vifor is an industry leader in bringing innovative therapies to U.S. dialysis organizations.
The company expects to execute its launch strategy in such a way that will potentially bolster Vafseo as a new oral standard of care for adult dialysis patients.
Per Akebia, an estimated 500,000 adult patients in the United States on dialysis suffer from anemia due to CKD, which often causes further complications in patients. Anemia is a blood disorder in which the human body cannot produce enough healthy red blood cells to carry adequate oxygen to the body's tissues.
CKD patients are prone to anemia because their kidneys do not produce enough erythropoietin, a hormone that helps regulate the production of red blood cells. Symptoms of anemia due to CKD include fatigue, dizziness, shortness of breath and cognitive dysfunction, which can lead to deterioration in health and even death if left untreated.
Akebia Therapeutics, Inc. Price and Consensus
Akebia Therapeutics, Inc. price-consensus-chart | Akebia Therapeutics, Inc. Quote
Zacks Rank and Stocks to Consider
Akebia currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industry are ADMA Biologics (ADMA - Free Report) , FibroGen (FGEN - Free Report) and Adicet Bio, Inc. (ACET - Free Report) . While ADMA sports a Zacks Rank #1 (Strong Buy), FGEN 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. In the past year, shares of ADMA have surged 106.4%.
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 FibroGen’s 2024 loss per share has narrowed from $1.14 to $1.09. During the same period, the estimate for FibroGen’s 2025 loss per share is pegged at 6 cents. In the past year, shares of FGEN have plunged 86.7%.
FGEN beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 2.26%.
In the past 30 days, the Zacks Consensus Estimate for Adicet Bio’s 2024 loss per share has narrowed from $1.81 to $1.72. During the same period, the consensus estimate for Adicet’s 2025 loss per share has narrowed from $1.87 to $1.84. In the past year, shares of ACET have plunged 61.5%.
ACET beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average negative surprise of 0.17%.