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AstraZeneca's Calquence sNDA Gets FDA Priority Tag for Expanded Use
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AstraZeneca (AZN - Free Report) announced that the FDA has accepted the supplemental new drug application (sNDA), seeking approval for the expanded use of Calquence (acalabrutinib) in mantle cell lymphoma (MCL).
The company is seeking approval for Calquence for the treatment of adult patients with previously untreated MCL, a rare and aggressive form of non-Hodgkin lymphoma. In the MCL indication, Calquence is currently approved for treating adult patients with MCL who have received at least one prior therapy in the United States and some other countries.
The drug is also approved for treating chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma in several countries across the world.
With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expected in the first quarter of 2025.
Year to date, shares of AstraZeneca have risen 18.1% compared with the industry’s growth of 20.1%.
Image Source: Zacks Investment Research
Filing Based on AZN’s ECHO Study
The latest sNDA for Calquence was based on data from the phase III ECHO study.
Data from the same showed that treatment with Calquence in combination with chemoimmunotherapy significantly delayed disease progression and showed a trend to improve survival in patients with untreated MCL.
The study data showed that treatment with Calquence plus bendamustine and Rituxan (rituximab) reduced the risk of disease progression or death by 27% as compared to standard-of-care (SoC) chemoimmunotherapy.
Patients who were treated with the Calquence combination experienced a median progression-free survival of 66.4 months as compared to 49.6 months for patients receiving SoC.
The overall survival (a key secondary endpoint) data remained immature at the time of this analysis.
AZN Holds Strong Position in Oncology Space
Oncology is AstraZeneca’s biggest segment and Calquence is a key drug in its portfolio. The company 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 and rose 22% in the first half of 2024. Besides Calquence, the strong oncology performance was driven by medicines such as Tagrisso, Lynparza Imfinzi and Enhertu (in partnership with Daiichi Sankyo).
In the first six months of 2024, Calquence generated sales worth $1.51 billion, up 22% year over year, driven by new patient share gains in frontline CLL worldwide.
Several label expansion studies evaluating Calquence, both as a monotherapy and in combination with SoC chemoimmunotherapy, are currently ongoing for treating multiple B-cell blood cancers, including CLL, MCL and diffuse large B-cell lymphoma.
AZN’s Zacks Rank & Other Stocks to Consider
AstraZeneca currently carries a Zacks Rank #2 (Buy).
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have increased 4.2%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.91 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 43%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, with the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from 46 cents to 28 cents. Loss per share estimates for 2025 have narrowed from $1.67 to $1.14. Year to date, shares of FULC have plunged 42.7%.
FULC’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 393.18%.
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AstraZeneca's Calquence sNDA Gets FDA Priority Tag for Expanded Use
AstraZeneca (AZN - Free Report) announced that the FDA has accepted the supplemental new drug application (sNDA), seeking approval for the expanded use of Calquence (acalabrutinib) in mantle cell lymphoma (MCL).
The company is seeking approval for Calquence for the treatment of adult patients with previously untreated MCL, a rare and aggressive form of non-Hodgkin lymphoma. In the MCL indication, Calquence is currently approved for treating adult patients with MCL who have received at least one prior therapy in the United States and some other countries.
The drug is also approved for treating chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma in several countries across the world.
With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expected in the first quarter of 2025.
Year to date, shares of AstraZeneca have risen 18.1% compared with the industry’s growth of 20.1%.
Image Source: Zacks Investment Research
Filing Based on AZN’s ECHO Study
The latest sNDA for Calquence was based on data from the phase III ECHO study.
Data from the same showed that treatment with Calquence in combination with chemoimmunotherapy significantly delayed disease progression and showed a trend to improve survival in patients with untreated MCL.
The study data showed that treatment with Calquence plus bendamustine and Rituxan (rituximab) reduced the risk of disease progression or death by 27% as compared to standard-of-care (SoC) chemoimmunotherapy.
Patients who were treated with the Calquence combination experienced a median progression-free survival of 66.4 months as compared to 49.6 months for patients receiving SoC.
The overall survival (a key secondary endpoint) data remained immature at the time of this analysis.
AZN Holds Strong Position in Oncology Space
Oncology is AstraZeneca’s biggest segment and Calquence is a key drug in its portfolio. The company 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 and rose 22% in the first half of 2024. Besides Calquence, the strong oncology performance was driven by medicines such as Tagrisso, Lynparza Imfinzi and Enhertu (in partnership with Daiichi Sankyo).
In the first six months of 2024, Calquence generated sales worth $1.51 billion, up 22% year over year, driven by new patient share gains in frontline CLL worldwide.
Several label expansion studies evaluating Calquence, both as a monotherapy and in combination with SoC chemoimmunotherapy, are currently ongoing for treating multiple B-cell blood cancers, including CLL, MCL and diffuse large B-cell lymphoma.
AZN’s Zacks Rank & Other Stocks to Consider
AstraZeneca currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the biotech sector are ANI Pharmaceuticals, Inc. (ANIP - Free Report) , Krystal Biotech, Inc. (KRYS - Free Report) and Fulcrum Therapeutics, Inc. (FULC - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have increased 4.2%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.91 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 43%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, with the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from 46 cents to 28 cents. Loss per share estimates for 2025 have narrowed from $1.67 to $1.14. Year to date, shares of FULC have plunged 42.7%.
FULC’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 393.18%.