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AstraZeneca's (AZN) Capivasertib Gets FDA Nod for Breast Cancer
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AstraZeneca (AZN - Free Report) announced that the FDA has approved its candidate capivasertib in combination with its breast cancer drug Faslodex (fulvestrant) for treating breast cancer. Capivasertib, a potential first-in-class AKT inhibitor, will be marketed by the name of Truqap.
Capivasertib has been approved in combination with Faslodex for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer whose tumors have qualifying alterations in the PIK3CA, AKT1 or PTEN genes following recurrence or progression on or after an endocrine-based regimen.
The approval was based on data from the CAPItello-291 phase III study in advanced HR-positive breast cancer. The study met both primary endpoints, improving progression-free survival in the overall patient population and in a prespecified biomarker subgroup of patients whose tumors had qualifying alterations in the PIK3CA, AKT1, or PTEN genes. Detailed data from the study showed that capivasertib in combination with Faslodex led to a 40% reduction in the risk of disease progression or death versus placebo plus Faslodex in the overall trial population.
Year to date, the stock has lost 5.9% against the industry’s 2.3% rise.
Image Source: Zacks Investment Research
Capivasertib is also being studied in late-stage studies for metastatic castration-resistant prostate cancer prostate cancer.
AstraZeneca is working on strengthening its oncology product portfolio through label expansions of existing products and progressing oncology pipeline candidates. Oncology sales now comprise around 40% of AstraZeneca ‘s total revenues.
Some important late-stage oncology candidates in AstraZeneca’s pipeline are datopotamab deruxtecan (non-small cell lung cancer [NSCLC] and inoperable or metastatic HR+ HER2- breast cancer, triple negative breast cancer), camizestrant (advanced breast cancer) and volrustomig (high-risk locally advanced cervical cancer and first-line metastatic NSCLC).
Zacks Rank & Stocks to Consider
Currently, AstraZeneca has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the drug/biotech sector are Dynavax Technologies Corporation (DVAX - Free Report) , MEI Pharma, Inc. (MEIP - Free Report) and Novo Nordisk (NVO - Free Report) .
In the past 30 days, estimates for Dynavax Technologies’ 2023 loss per share have narrowed from 22 cents to 12 cents. Meanwhile, during the same period, earnings per share estimates for 2024 have improved from 8 cents to 18 cents. Year to date, shares of DVAX have rallied 27.1%.
Earnings of Dynavax Technologies beat estimates in two of the past four quarters while missing in the other two, the average surprise being 293.21%.
In the past 60 days, estimates for MEI Pharma’s 2023 have improved from a loss per share of $4.89 to earnings of $3.48 per share. Year to date, shares of MEIP have rallied 25.2%.
Earnings of MEI Pharma beat estimates in each of the past four quarters, the average surprise being 222.46%.
Estimates for Novo Nordisk’s 2023 earnings per share have increased from $2.51 to $2.62 over the past 30 days. Estimates for 2024 have jumped from $2.91 per share to $3.07 over the same timeframe. NVO’s stock has surged 47.2% year to date.
Earnings of Novo Nordisk beat estimates in two of the past four quarters while missing in one and meeting in one, the average surprise being 0.58%.
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AstraZeneca's (AZN) Capivasertib Gets FDA Nod for Breast Cancer
AstraZeneca (AZN - Free Report) announced that the FDA has approved its candidate capivasertib in combination with its breast cancer drug Faslodex (fulvestrant) for treating breast cancer. Capivasertib, a potential first-in-class AKT inhibitor, will be marketed by the name of Truqap.
Capivasertib has been approved in combination with Faslodex for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer whose tumors have qualifying alterations in the PIK3CA, AKT1 or PTEN genes following recurrence or progression on or after an endocrine-based regimen.
The approval was based on data from the CAPItello-291 phase III study in advanced HR-positive breast cancer. The study met both primary endpoints, improving progression-free survival in the overall patient population and in a prespecified biomarker subgroup of patients whose tumors had qualifying alterations in the PIK3CA, AKT1, or PTEN genes. Detailed data from the study showed that capivasertib in combination with Faslodex led to a 40% reduction in the risk of disease progression or death versus placebo plus Faslodex in the overall trial population.
Year to date, the stock has lost 5.9% against the industry’s 2.3% rise.
Image Source: Zacks Investment Research
Capivasertib is also being studied in late-stage studies for metastatic castration-resistant prostate cancer prostate cancer.
AstraZeneca is working on strengthening its oncology product portfolio through label expansions of existing products and progressing oncology pipeline candidates. Oncology sales now comprise around 40% of AstraZeneca ‘s total revenues.
Some important late-stage oncology candidates in AstraZeneca’s pipeline are datopotamab deruxtecan (non-small cell lung cancer [NSCLC] and inoperable or metastatic HR+ HER2- breast cancer, triple negative breast cancer), camizestrant (advanced breast cancer) and volrustomig (high-risk locally advanced cervical cancer and first-line metastatic NSCLC).
Zacks Rank & Stocks to Consider
Currently, AstraZeneca has a Zacks Rank #3 (Hold).
AstraZeneca PLC Price and Consensus
AstraZeneca PLC price-consensus-chart | AstraZeneca PLC Quote
Some better-ranked stocks in the drug/biotech sector are Dynavax Technologies Corporation (DVAX - Free Report) , MEI Pharma, Inc. (MEIP - Free Report) and Novo Nordisk (NVO - Free Report) .
While Dynavax Technologies and MEI Pharma sport a Zacks Rank #1 (Strong Buy) each, Novo Nordisk carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, estimates for Dynavax Technologies’ 2023 loss per share have narrowed from 22 cents to 12 cents. Meanwhile, during the same period, earnings per share estimates for 2024 have improved from 8 cents to 18 cents. Year to date, shares of DVAX have rallied 27.1%.
Earnings of Dynavax Technologies beat estimates in two of the past four quarters while missing in the other two, the average surprise being 293.21%.
In the past 60 days, estimates for MEI Pharma’s 2023 have improved from a loss per share of $4.89 to earnings of $3.48 per share. Year to date, shares of MEIP have rallied 25.2%.
Earnings of MEI Pharma beat estimates in each of the past four quarters, the average surprise being 222.46%.
Estimates for Novo Nordisk’s 2023 earnings per share have increased from $2.51 to $2.62 over the past 30 days. Estimates for 2024 have jumped from $2.91 per share to $3.07 over the same timeframe. NVO’s stock has surged 47.2% year to date.
Earnings of Novo Nordisk beat estimates in two of the past four quarters while missing in one and meeting in one, the average surprise being 0.58%.