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GSK's NDA for Daprodustat to be Reviewed by an FDA Panel
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GSK plc (GSK - Free Report) announced that the FDA has informed that it will conduct an advisory committee meeting to review the new drug application (NDA) seeking approval of daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for anemia associated with chronic renal disease (CKD).
The date of the meeting of the Cardiovascular and Renal Drugs Advisory Committee is set on Oct 26, 2022.
The FDA accepted GSK’s NDA for daprodustat in April and granted a standard review to the same. A decision is expected on Feb 1, 2023. A marketing authorization application (MAA) for daprodustat is also under review in Europe. Daprodustat is only approved in Japan as Duvroq for anemia associated with CKD.
GSK’s stock has declined 42.9% this year so far compared with a decrease of 24.6% for the industry.
Image Source: Zacks Investment Research
The regulatory applications for daprodustat are based on data from the ASCEND phase III program, which consisted of five studies on daprodustat for the treatment of anemia across the spectrum of CKD, both on dialysis and not on dialysis.
All the studies met their primary efficacy and safety endpoints in non-dialysis and dialysis CKD patients. The studies showed that daprodustat improved or maintained hemoglobin (Hgb) levels within the target range. Data from key cardiovascular outcomes studies for non-dialysis (ASCEND-ND) and dialysis patients (ASCEND-D) showed that daprodustat was non-inferior to an erythropoietin stimulating agent, a standard treatment in such patient population, in the risk of major adverse cardiovascular events, the co-primary endpoint of both studies.
Some better-ranked stocks in the same sector are Morphic , Sesen Bio and Agenus (AGEN - Free Report) , all carrying a Zacks Rank #1 at present.
In the past 60 days, estimates for Morphic’s 2022 loss per share have narrowed from $3.47 to $1.75. Loss estimates for 2023 have narrowed from $3.96 to $3.77 during the same period. Shares of Morphic have lost 41.5% in the year-to-date period.
Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average.
Estimates for Sesen Bio for 2023 have narrowed from a loss of 27 cents per share to a loss of 1 cent per share over the past 60 days. Shares of Sesen Bio have declined 26.4% this year so far.
Earnings of Sesen Bio beat estimates in all the last four quarters, delivering a four-quarter surprise of 89.49%, on average.
Estimates for Agenus’ 2022 bottom line have narrowed from a loss of 89 cents to 70 cents in the past 60 days. Loss estimates for 2023 have narrowed from 64 cents per share to 60 cents per share over the same time frame. Agenus’ stock is down 24.8% in the year-to-date period.
Earnings of Agenus beat estimates in three of the last four quarters while missing in one. The stock delivered a four-quarter average negative surprise of 12.02%.
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GSK's NDA for Daprodustat to be Reviewed by an FDA Panel
GSK plc (GSK - Free Report) announced that the FDA has informed that it will conduct an advisory committee meeting to review the new drug application (NDA) seeking approval of daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for anemia associated with chronic renal disease (CKD).
The date of the meeting of the Cardiovascular and Renal Drugs Advisory Committee is set on Oct 26, 2022.
The FDA accepted GSK’s NDA for daprodustat in April and granted a standard review to the same. A decision is expected on Feb 1, 2023. A marketing authorization application (MAA) for daprodustat is also under review in Europe. Daprodustat is only approved in Japan as Duvroq for anemia associated with CKD.
GSK’s stock has declined 42.9% this year so far compared with a decrease of 24.6% for the industry.
Image Source: Zacks Investment Research
The regulatory applications for daprodustat are based on data from the ASCEND phase III program, which consisted of five studies on daprodustat for the treatment of anemia across the spectrum of CKD, both on dialysis and not on dialysis.
All the studies met their primary efficacy and safety endpoints in non-dialysis and dialysis CKD patients. The studies showed that daprodustat improved or maintained hemoglobin (Hgb) levels within the target range. Data from key cardiovascular outcomes studies for non-dialysis (ASCEND-ND) and dialysis patients (ASCEND-D) showed that daprodustat was non-inferior to an erythropoietin stimulating agent, a standard treatment in such patient population, in the risk of major adverse cardiovascular events, the co-primary endpoint of both studies.
Zacks Rank & Stocks to Consider
GSK currently has a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Some better-ranked stocks in the same sector are Morphic , Sesen Bio and Agenus (AGEN - Free Report) , all carrying a Zacks Rank #1 at present.
In the past 60 days, estimates for Morphic’s 2022 loss per share have narrowed from $3.47 to $1.75. Loss estimates for 2023 have narrowed from $3.96 to $3.77 during the same period. Shares of Morphic have lost 41.5% in the year-to-date period.
Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average.
Estimates for Sesen Bio for 2023 have narrowed from a loss of 27 cents per share to a loss of 1 cent per share over the past 60 days. Shares of Sesen Bio have declined 26.4% this year so far.
Earnings of Sesen Bio beat estimates in all the last four quarters, delivering a four-quarter surprise of 89.49%, on average.
Estimates for Agenus’ 2022 bottom line have narrowed from a loss of 89 cents to 70 cents in the past 60 days. Loss estimates for 2023 have narrowed from 64 cents per share to 60 cents per share over the same time frame. Agenus’ stock is down 24.8% in the year-to-date period.
Earnings of Agenus beat estimates in three of the last four quarters while missing in one. The stock delivered a four-quarter average negative surprise of 12.02%.