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Ardelyx (ARDX) Up 41% After FDA Committee Endorses CKD Drug
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Shares of Ardelyx (ARDX - Free Report) were up 41% on Nov 17 after management announced thatan FDA Advisory Committee recommended approving the company’s new drug application (“NDA”) for Xphozah (tenapanor) oral pill. The NDA filing seeks approval for the oral pill to reduce elevated serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.
The FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 9:4, with the majority favoring treatment with the drug as monotherapy. The CRDAC also voted 10:2 (with one abstention) favoring the treatment combination of Xphozah plus phosphate binders. The FDA committee concluded that the benefits of Xphozah monotherapy and Xphozah combined with phosphate binders outweigh the risks for controlling elevated serum phosphate levels.
Shares of Ardelyx were likely up as investors anticipated a potential approval of the NDA. Generally, the FDA’s decision stands in alignment with its advisory committees.
Shares of Ardelyx have gained 56.4% in the year so far against the industry’s 31.2% fall.
Image Source: Zacks Investment Research
This positive decision from the CRDAC is based on data from a comprehensive development program comprising three late-stage studies — PHREEDOM, BLOCK and AMPLIFY — that evaluated the safety and efficacy of Xphozah for controlling serum phosphorus in adult patients with CKD on dialysis in more than 1200 study participants. These studies met all of their primary and key secondary endpoints.
We remind investors that the FDA issued a complete response letter (CRL) to Xphozah NDA filing last year in July. Though the regulatory agency did not identify any safety or clinical issues in the NDA, it requested the company to conduct an additional clinical study that would show a clinically relevant treatment effect of Xphozah on serum phosphorus. This need to conduct an additional study was based on previously submitted clinical data, making the FDA characterize the drug’s treatment effects as small and of unclear clinical significance.
Tenapanor is already approved in the United States and Canada for treating irritable bowel syndrome with constipation (IBS-C) in adults. The drug is currently being marketed under the trade name Ibsrela and was commercially launched in the United States in second-quarter 2022.
Ardelyx currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Angion Biomedica , Celularity (CELU - Free Report) and Entera Bio (ENTX - Free Report) . While Angion Biomedica and Celularity sport a Zacks Rank #1 (Strong Buy) at present, Entera Bio carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Angion Biomedica’s 2022 loss per share have narrowed from $1.64 to $1.53. During the same period, the loss estimates per share for 2023 have narrowed from $1.54 to $1.43. Shares of Angion Biomedica have plunged 70.3% in the year-to-date period.
Earnings of Angion Biomedica beat estimates in three of the last four quarters and missed the mark once, witnessing a surprise of 66.42% on average. In the last reported quarter, ANGN delivered an earnings surprise of 41.67%.
In the past 60 days, estimates for Celularity’s 2022 loss per share have narrowed from 84 cents to 56 cents. During the same period, the loss estimates per share for 2023 have narrowed from $1.04 to $0.97. Shares of Celularity have plunged 65.6% in the year-to-date period.
Earnings of Celularity beat estimates in three of the last four quarters and missed the mark once, witnessing a surprise of 51.01% on average. In the last reported quarter, Celularity delivered an earnings surprise of 111.54%.
In the past 60 days, estimates for Entera Bio’s 2022 loss per share have narrowed from 55 cents to 47 cents. Shares of Entera Bio have plunged 75.8% in the year-to-date period.
Earnings of Entera Bio beat estimates in each of the last four quarters, witnessing a surprise of 89.07% on average. In the last reported quarter, Entera Bio delivered an earnings surprise of 31.25%.
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Ardelyx (ARDX) Up 41% After FDA Committee Endorses CKD Drug
Shares of Ardelyx (ARDX - Free Report) were up 41% on Nov 17 after management announced thatan FDA Advisory Committee recommended approving the company’s new drug application (“NDA”) for Xphozah (tenapanor) oral pill. The NDA filing seeks approval for the oral pill to reduce elevated serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.
The FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 9:4, with the majority favoring treatment with the drug as monotherapy. The CRDAC also voted 10:2 (with one abstention) favoring the treatment combination of Xphozah plus phosphate binders. The FDA committee concluded that the benefits of Xphozah monotherapy and Xphozah combined with phosphate binders outweigh the risks for controlling elevated serum phosphate levels.
Shares of Ardelyx were likely up as investors anticipated a potential approval of the NDA. Generally, the FDA’s decision stands in alignment with its advisory committees.
Shares of Ardelyx have gained 56.4% in the year so far against the industry’s 31.2% fall.
Image Source: Zacks Investment Research
This positive decision from the CRDAC is based on data from a comprehensive development program comprising three late-stage studies — PHREEDOM, BLOCK and AMPLIFY — that evaluated the safety and efficacy of Xphozah for controlling serum phosphorus in adult patients with CKD on dialysis in more than 1200 study participants. These studies met all of their primary and key secondary endpoints.
We remind investors that the FDA issued a complete response letter (CRL) to Xphozah NDA filing last year in July. Though the regulatory agency did not identify any safety or clinical issues in the NDA, it requested the company to conduct an additional clinical study that would show a clinically relevant treatment effect of Xphozah on serum phosphorus. This need to conduct an additional study was based on previously submitted clinical data, making the FDA characterize the drug’s treatment effects as small and of unclear clinical significance.
Tenapanor is already approved in the United States and Canada for treating irritable bowel syndrome with constipation (IBS-C) in adults. The drug is currently being marketed under the trade name Ibsrela and was commercially launched in the United States in second-quarter 2022.
Ardelyx, Inc. Price
Ardelyx, Inc. price | Ardelyx, Inc. Quote
Zacks Rank & Stocks to Consider
Ardelyx currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Angion Biomedica , Celularity (CELU - Free Report) and Entera Bio (ENTX - Free Report) . While Angion Biomedica and Celularity sport a Zacks Rank #1 (Strong Buy) at present, Entera Bio carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Angion Biomedica’s 2022 loss per share have narrowed from $1.64 to $1.53. During the same period, the loss estimates per share for 2023 have narrowed from $1.54 to $1.43. Shares of Angion Biomedica have plunged 70.3% in the year-to-date period.
Earnings of Angion Biomedica beat estimates in three of the last four quarters and missed the mark once, witnessing a surprise of 66.42% on average. In the last reported quarter, ANGN delivered an earnings surprise of 41.67%.
In the past 60 days, estimates for Celularity’s 2022 loss per share have narrowed from 84 cents to 56 cents. During the same period, the loss estimates per share for 2023 have narrowed from $1.04 to $0.97. Shares of Celularity have plunged 65.6% in the year-to-date period.
Earnings of Celularity beat estimates in three of the last four quarters and missed the mark once, witnessing a surprise of 51.01% on average. In the last reported quarter, Celularity delivered an earnings surprise of 111.54%.
In the past 60 days, estimates for Entera Bio’s 2022 loss per share have narrowed from 55 cents to 47 cents. Shares of Entera Bio have plunged 75.8% in the year-to-date period.
Earnings of Entera Bio beat estimates in each of the last four quarters, witnessing a surprise of 89.07% on average. In the last reported quarter, Entera Bio delivered an earnings surprise of 31.25%.