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Calliditas (CALT) Up as sNDA for Tarpeyo Gets Priority Review
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Calliditas Therapeutics' (CALT - Free Report) shares were up almost 7% on Aug 18, as the FDA accepted the submission of a supplement new drug application (sNDA) seeking to convert accelerated approval of Tarpeyo (budesonide) delayed-release capsule to full approval.
The sNDA was also granted priority review with a Prescription Drug User Fee Act (PDUFA) on Dec 20, 2023.
Tarpeyo received accelerated approval in December 2021 to reduce levels of protein in the urine (proteinuria) in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN), who are at high risk of disease progression. The drug was launched in the United States in January 2022.
The sNDA is based on an entire data set from a global phase III NefIgArd study. The study evaluated the efficacy and safety of Tarpeyo (developed under the project name Nefecon) at a once-daily dose of 16 mg compared to a placebo in adult patients with primary IgAN who were already on optimized RASi therapy. The study met its primary endpoint of kidney function, as Nefecon showed a statistically significant benefit in estimated glomerular filtration rate compared with placebo.
Shares of Calliditas have lost 3.5% year to date compared with the industry’s 5.8% decline.
Image Source: Zacks Investment Research
IgAN is a long-term kidney condition where a protein called IgA builds up in the kidneys, which can potentially lead to end-stage renal disease.This illness affects many people globally, especially in the United States. People with primary IgAN who are at risk of their disease getting worse quickly have desperately needed an effective treatment.
Tarpeyo has been witnessing strong sales uptake in the United States since its launch. The drug generated revenues of $42.5 million in the first half of 2023.
Furthermore, Calliditas is in a collaborative effort with its European commercial partner, STADA Arzneimittel AG, to pursue complete approval for Nefecon (under the brand name Kinpeygo) to treat adults with primary IgAN whose disease is at risk of rapidly getting worse. Kinpeygo received conditional marketing approval in Europe in July 2022. The drug is the first and only approved treatment for IgAN in Europe.
Calliditas Therapeutics AB Sponsored ADR Price and Consensus
In the past 90 days, the Zacks Consensus Estimate for Emergent Biosolutions has widened from a loss of $1.32 per share to a loss of $1.35 for 2023. The bottom-line estimate has gone down from $2.06 to $1.06 for 2024 during the same time frame. Shares of the company have lost 56.9% year to date.
EBS’ earnings missed estimates in each of the trailing four quarters, delivering an average negative surprise of 577.88%.
In the past 90 days, the Zacks Consensus Estimate for Annovis Bio has narrowed from a loss of $4.89 per share to a loss of $4.38 for 2023. The bottom-line estimate has narrowed from a loss of $3.18 to $2.77 for 2024 during the same time frame. Shares of the company have lost 5.5% year to date.
ANVS’ earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 13.40%.
In the past 90 days, the Zacks Consensus Estimate for Corcept’s earnings has gone up from 66 cents per share to 78 cents for 2023. The bottom-line estimate has also improved from 64 cents to 83 cents for 2024 during the same time frame. Shares of the company have rallied 52.3% year to date.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.
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Calliditas (CALT) Up as sNDA for Tarpeyo Gets Priority Review
Calliditas Therapeutics' (CALT - Free Report) shares were up almost 7% on Aug 18, as the FDA accepted the submission of a supplement new drug application (sNDA) seeking to convert accelerated approval of Tarpeyo (budesonide) delayed-release capsule to full approval.
The sNDA was also granted priority review with a Prescription Drug User Fee Act (PDUFA) on Dec 20, 2023.
Tarpeyo received accelerated approval in December 2021 to reduce levels of protein in the urine (proteinuria) in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN), who are at high risk of disease progression. The drug was launched in the United States in January 2022.
The sNDA is based on an entire data set from a global phase III NefIgArd study. The study evaluated the efficacy and safety of Tarpeyo (developed under the project name Nefecon) at a once-daily dose of 16 mg compared to a placebo in adult patients with primary IgAN who were already on optimized RASi therapy. The study met its primary endpoint of kidney function, as Nefecon showed a statistically significant benefit in estimated glomerular filtration rate compared with placebo.
Shares of Calliditas have lost 3.5% year to date compared with the industry’s 5.8% decline.
Image Source: Zacks Investment Research
IgAN is a long-term kidney condition where a protein called IgA builds up in the kidneys, which can potentially lead to end-stage renal disease.This illness affects many people globally, especially in the United States. People with primary IgAN who are at risk of their disease getting worse quickly have desperately needed an effective treatment.
Tarpeyo has been witnessing strong sales uptake in the United States since its launch. The drug generated revenues of $42.5 million in the first half of 2023.
Furthermore, Calliditas is in a collaborative effort with its European commercial partner, STADA Arzneimittel AG, to pursue complete approval for Nefecon (under the brand name Kinpeygo) to treat adults with primary IgAN whose disease is at risk of rapidly getting worse. Kinpeygo received conditional marketing approval in Europe in July 2022. The drug is the first and only approved treatment for IgAN in Europe.
Calliditas Therapeutics AB Sponsored ADR Price and Consensus
Calliditas Therapeutics AB Sponsored ADR price-consensus-chart | Calliditas Therapeutics AB Sponsored ADR Quote
Zacks Rank & Other Stocks to Consider
Calliditas currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the same industry are Emergent Biosolutions (EBS - Free Report) , Annovis Bio (ANVS - Free Report) and Corcept Therapeutics (CORT - Free Report) , each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for Emergent Biosolutions has widened from a loss of $1.32 per share to a loss of $1.35 for 2023. The bottom-line estimate has gone down from $2.06 to $1.06 for 2024 during the same time frame. Shares of the company have lost 56.9% year to date.
EBS’ earnings missed estimates in each of the trailing four quarters, delivering an average negative surprise of 577.88%.
In the past 90 days, the Zacks Consensus Estimate for Annovis Bio has narrowed from a loss of $4.89 per share to a loss of $4.38 for 2023. The bottom-line estimate has narrowed from a loss of $3.18 to $2.77 for 2024 during the same time frame. Shares of the company have lost 5.5% year to date.
ANVS’ earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 13.40%.
In the past 90 days, the Zacks Consensus Estimate for Corcept’s earnings has gone up from 66 cents per share to 78 cents for 2023. The bottom-line estimate has also improved from 64 cents to 83 cents for 2024 during the same time frame. Shares of the company have rallied 52.3% year to date.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.