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AZN, Daiichi's Enhertu Gets Breakthrough Tag for Expanded Cancer Use
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Key Takeaways
FDA grants Enhertu a Breakthrough Therapy designation for early HER2-positive breast cancer.
AZN noted the decision was based on DESTINY-Breast05 results showing lower invasive disease recurrence.
AZN's phase III LATIFY study with Imfinzi combo missed its primary overall survival goal in lung cancer.
AstraZeneca (AZN - Free Report) and its Japan-based partner Daiichi Sankyo announced that the FDA has granted a Breakthrough Therapy designation (“BTD”) to their blockbuster antibody-drug conjugate (ADC), Enhertu, for expanded use in breast cancer.
The FDA has now granted the BTD to Enhertu for treating adult patients with HER2-positive early breast cancer with residual invasive disease in the breast and/or axillary lymph nodes after neoadjuvant treatment and high risk of disease recurrence.
This marks the tenth BTD for Enhertu and underlines the potential of the drug to deliver transformational results in the treatment of breast cancer.
The FDA’s Breakthrough Therapy designation is a process that speeds up the development and review of drugs for serious or life-threatening conditions.
The latest BTD was based on data from the phase III DESTINY-Breast05, which showed that treatment with Enhertu may help halt invasive disease recurrence compared with the current standard of care, potentially helping more patients achieve a cure.
AZN’s Price Performance
In the past six months, shares of AstraZeneca have rallied 29.3% compared with the industry’s rise of 26.2%.
Image Source: Zacks Investment Research
AZN, Daiichi’s Recent Developments With Enhertu
Enhertu is presently approved for the second-line treatment of patients with HER2-positive breast cancer in more than 85 countries, including the United States. It is also approved in HER2-targeted indications for lung and gastric cancers.
Earlier this month, the FDA approved Enhertu in combination with Roche’s Perjeta (pertuzumab) as a first-line treatment for adult patients with unresectable or metastatic HER2-positive breast cancer in the United States. This approval was based on data from the phase III DESTINY-Breast09 study.
Enhertu is the first ADC developed under AstraZeneca’s collaboration with Daiichi Sankyo, followed by Datroway, which received its first FDA approval for the treatment of breast cancer and, more recently, for the treatment of lung cancer in 2025.
Per the terms of the partnership, both companies are jointly responsible for developing and marketing the drugs worldwide, except in Japan, where Daiichi maintains exclusive rights for both. Daiichi is also responsible for the manufacturing and supply of both Enhertu and Datroway.
AZN and Daiichi are also pursuing broad development programs for Enhertu and Datroway, testing them as monotherapies and in combinations across multiple tumor types.
AZN’s Update on Phase III LATIFY Study
In a separate press release, AstraZeneca announced that the phase III LATIFY study, which evaluated its pipeline candidate, ceralasertib, in combination with its blockbuster cancer drug, Imfinzi, in previously treated patients with advanced non-small cell lung cancer, failed to meet the primary endpoint of overall survival.
The LATIFY study investigated patients without actionable genomic alterations (AGAs) whose disease progressed on or after prior immunotherapy and platinum-based chemotherapy.
Treatment with ceralasertib plus Imfinzi was generally well tolerated, showing a safety profile similar to each drug’s known characteristics and no new safety concerns.
Imfinzi, either as a monotherapy or in combination with other drugs, is approved for several types of cancer indications, including liver cancer, lung cancer, endometrial cancer, bile-duct and gallbladder cancer and muscle-invasive bladder cancer.
Imfinzi generated sales of $4.32 billion in the first nine months of 2025, up 25%, driven by demand growth in lung and liver cancer indications.
AZN’s Zacks Rank & Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold).
In the past 60 days, estimates for CorMedix’s 2025 earnings per share (EPS) have increased from $1.85 to $2.87. EPS estimates for 2026 have moved up from $2.49 to $2.88 during the same period. CRMD stock has lost 27.4% in the past six months.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.
In the past 60 days, estimates for Castle Biosciences’ loss per share have narrowed from 64 cents to 34 cents for 2025. During the same time, loss per share estimates for 2026 have narrowed from $1.82 to $1.06. In the past six months, shares of CSTL have surged 109.2%.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, the average surprise being 66.11%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 EPS have increased from $7.29 to $7.56. EPS estimates for 2026 have moved up from $7.81 to $8.08 during the same period. ANIP stock has rallied 25.4% in the past six months.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 21.24%.
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AZN, Daiichi's Enhertu Gets Breakthrough Tag for Expanded Cancer Use
Key Takeaways
AstraZeneca (AZN - Free Report) and its Japan-based partner Daiichi Sankyo announced that the FDA has granted a Breakthrough Therapy designation (“BTD”) to their blockbuster antibody-drug conjugate (ADC), Enhertu, for expanded use in breast cancer.
The FDA has now granted the BTD to Enhertu for treating adult patients with HER2-positive early breast cancer with residual invasive disease in the breast and/or axillary lymph nodes after neoadjuvant treatment and high risk of disease recurrence.
This marks the tenth BTD for Enhertu and underlines the potential of the drug to deliver transformational results in the treatment of breast cancer.
The FDA’s Breakthrough Therapy designation is a process that speeds up the development and review of drugs for serious or life-threatening conditions.
The latest BTD was based on data from the phase III DESTINY-Breast05, which showed that treatment with Enhertu may help halt invasive disease recurrence compared with the current standard of care, potentially helping more patients achieve a cure.
AZN’s Price Performance
In the past six months, shares of AstraZeneca have rallied 29.3% compared with the industry’s rise of 26.2%.
Image Source: Zacks Investment Research
AZN, Daiichi’s Recent Developments With Enhertu
Enhertu is presently approved for the second-line treatment of patients with HER2-positive breast cancer in more than 85 countries, including the United States. It is also approved in HER2-targeted indications for lung and gastric cancers.
Earlier this month, the FDA approved Enhertu in combination with Roche’s Perjeta (pertuzumab) as a first-line treatment for adult patients with unresectable or metastatic HER2-positive breast cancer in the United States. This approval was based on data from the phase III DESTINY-Breast09 study.
Enhertu is the first ADC developed under AstraZeneca’s collaboration with Daiichi Sankyo, followed by Datroway, which received its first FDA approval for the treatment of breast cancer and, more recently, for the treatment of lung cancer in 2025.
Per the terms of the partnership, both companies are jointly responsible for developing and marketing the drugs worldwide, except in Japan, where Daiichi maintains exclusive rights for both. Daiichi is also responsible for the manufacturing and supply of both Enhertu and Datroway.
AZN and Daiichi are also pursuing broad development programs for Enhertu and Datroway, testing them as monotherapies and in combinations across multiple tumor types.
AZN’s Update on Phase III LATIFY Study
In a separate press release, AstraZeneca announced that the phase III LATIFY study, which evaluated its pipeline candidate, ceralasertib, in combination with its blockbuster cancer drug, Imfinzi, in previously treated patients with advanced non-small cell lung cancer, failed to meet the primary endpoint of overall survival.
The LATIFY study investigated patients without actionable genomic alterations (AGAs) whose disease progressed on or after prior immunotherapy and platinum-based chemotherapy.
Treatment with ceralasertib plus Imfinzi was generally well tolerated, showing a safety profile similar to each drug’s known characteristics and no new safety concerns.
Imfinzi, either as a monotherapy or in combination with other drugs, is approved for several types of cancer indications, including liver cancer, lung cancer, endometrial cancer, bile-duct and gallbladder cancer and muscle-invasive bladder cancer.
Imfinzi generated sales of $4.32 billion in the first nine months of 2025, up 25%, driven by demand growth in lung and liver cancer indications.
AZN’s Zacks Rank & Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are CorMedix (CRMD - Free Report) , Castle Biosciences (CSTL - Free Report) and ANI Pharmaceuticals (ANIP - Free Report) . While CorMedix and Castle Biosciences sport a Zacks Rank #1 (Strong Buy), ANI Pharmaceuticals holds a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CorMedix’s 2025 earnings per share (EPS) have increased from $1.85 to $2.87. EPS estimates for 2026 have moved up from $2.49 to $2.88 during the same period. CRMD stock has lost 27.4% in the past six months.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.
In the past 60 days, estimates for Castle Biosciences’ loss per share have narrowed from 64 cents to 34 cents for 2025. During the same time, loss per share estimates for 2026 have narrowed from $1.82 to $1.06. In the past six months, shares of CSTL have surged 109.2%.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, the average surprise being 66.11%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 EPS have increased from $7.29 to $7.56. EPS estimates for 2026 have moved up from $7.81 to $8.08 during the same period. ANIP stock has rallied 25.4% in the past six months.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 21.24%.