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Gilead's (GILD) Veklury Gets FDA Nod for Label Expansion
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Gilead Sciences, Inc. (GILD - Free Report) announced that the FDA approved a supplemental new drug application (sNDA) for the use of the COVID-19 drug Veklury (remdesivir).
The drug has now been approved for treating COVID-19 patients with severe renal impairment, including those on dialysis.
This approval was based on results from a phase I study (GS-US-540-9015), as well as results from the late-stage REDPINE trial that demonstrated the pharmacokinetics (PK) and safety profile of Veklury in this population. No new safety signals were observed in either of the studies.
Per Gilead, Veklury is now the first approved antiviral treatment for patients across all stages of renal disease. These patients, with advanced CKD and end-stage kidney disease (ESKD), are at high risk for severe COVID-19 with hospitalization and mortality rates remain high, even for those who are vaccinated. Hence, the approval is an important advance for this patient population.
Last month, the European Commission also approved the drug’s label expansion to treat COVID-19 in people with severe renal impairment, including those on dialysis.
Veklury is indicated in the United States for the treatment of COVID-19 in adults and pediatric patients who are either hospitalized or not hospitalized and are at high risk for progression to severe COVID-19, including hospitalization or death in the United States.
Shares of Gilead have lost 10.3% in the year so far compared with the industry’s 10% decline.
Image Source: Zacks Investment Research
Gilead is also advancing an investigational oral antiviral, obeldesivir, for the treatment of COVID-19. Obeldesivir is a direct-acting nucleoside inhibitor of the SARS-CoV-2 RNA-dependent RNA polymerase. Once metabolized, it has the same mechanism as Veklury to stop the virus replication.
Gilead reported lower-than-expected first-quarter results as a decline in Veklury sales due to lower rates of COVID-related hospitalization hurt its performance. Sales are likely to have declined in the second quarter as the pandemic has eased out.
Nevertheless, growth in the flagship HIV therapy Biktarvy and oncology revenues increased, driven by the cell therapy franchise and Trodelvy maintained momentum for the company.
Gilead is looking to diversify in the lucrative oncology space. The Cell Therapy franchise, comprising Yescarta and Tecartus, also continues to witness a steady increase in sales, primarily due to higher demand for Yescarta in R/R LBCL and Tecartus in R/R ALL and MCL. The uptake of the breast cancer drug Trodelvy has been strong as well.
Alkermes’ earnings estimates for fiscal 2023 have increased from 20 cents to 79 cents in the past 60 days. The earnings estimates for 2024 have also increased from $1.73 to $2.08 in the past 60 days.
Alkermes’ earnings beat estimates in three of the last four quarters and met the mark on one occasion, the average surprise being 90.83%.
Over the past 30 days, earnings estimates for LGND have increased 46 cents to $5.25. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.
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Gilead's (GILD) Veklury Gets FDA Nod for Label Expansion
Gilead Sciences, Inc. (GILD - Free Report) announced that the FDA approved a supplemental new drug application (sNDA) for the use of the COVID-19 drug Veklury (remdesivir).
The drug has now been approved for treating COVID-19 patients with severe renal impairment, including those on dialysis.
This approval was based on results from a phase I study (GS-US-540-9015), as well as results from the late-stage REDPINE trial that demonstrated the pharmacokinetics (PK) and safety profile of Veklury in this population. No new safety signals were observed in either of the studies.
Per Gilead, Veklury is now the first approved antiviral treatment for patients across all stages of renal disease. These patients, with advanced CKD and end-stage kidney disease (ESKD), are at high risk for severe COVID-19 with hospitalization and mortality rates remain high, even for those who are vaccinated. Hence, the approval is an important advance for this patient population.
Last month, the European Commission also approved the drug’s label expansion to treat COVID-19 in people with severe renal impairment, including those on dialysis.
Veklury is indicated in the United States for the treatment of COVID-19 in adults and pediatric patients who are either hospitalized or not hospitalized and are at high risk for progression to severe COVID-19, including hospitalization or death in the United States.
Shares of Gilead have lost 10.3% in the year so far compared with the industry’s 10% decline.
Image Source: Zacks Investment Research
Gilead is also advancing an investigational oral antiviral, obeldesivir, for the treatment of COVID-19. Obeldesivir is a direct-acting nucleoside inhibitor of the SARS-CoV-2 RNA-dependent RNA polymerase. Once metabolized, it has the same mechanism as Veklury to stop the virus replication.
Gilead reported lower-than-expected first-quarter results as a decline in Veklury sales due to lower rates of COVID-related hospitalization hurt its performance. Sales are likely to have declined in the second quarter as the pandemic has eased out.
Nevertheless, growth in the flagship HIV therapy Biktarvy and oncology revenues increased, driven by the cell therapy franchise and Trodelvy maintained momentum for the company.
Gilead is looking to diversify in the lucrative oncology space. The Cell Therapy franchise, comprising Yescarta and Tecartus, also continues to witness a steady increase in sales, primarily due to higher demand for Yescarta in R/R LBCL and Tecartus in R/R ALL and MCL. The uptake of the breast cancer drug Trodelvy has been strong as well.
Zacks Rank and Stocks to Consider
Gilead currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the overall healthcare sector are Alkermes (ALKS - Free Report) and Ligand Pharmaceuticals (LGND - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Alkermes’ earnings estimates for fiscal 2023 have increased from 20 cents to 79 cents in the past 60 days. The earnings estimates for 2024 have also increased from $1.73 to $2.08 in the past 60 days.
Alkermes’ earnings beat estimates in three of the last four quarters and met the mark on one occasion, the average surprise being 90.83%.
Over the past 30 days, earnings estimates for LGND have increased 46 cents to $5.25. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.