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AZN, Daiichi's Enhertu Gets FDA Nod for Two New Breast Cancer Settings
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Key Takeaways
AstraZeneca and Daiichi secured FDA nods for Enhertu in neoadjuvant and adjuvant use.
The approvals were backed by phase III DESTINY-Breast11 and DESTINY-Breast05 studies.
Enhertu is now approved to treat HER2-positive early breast cancer in stage II or III adult patients.
AstraZeneca (AZN - Free Report) and its Japan-based partner Daiichi Sankyo announced that the FDA has approved their blockbuster antibody-drug conjugate (ADC), Enhertu, for two new breast cancer indications.
The drug is now approved for both the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer. The approvals were based on data from the phase III DESTINY-Breast11 and DESTINY-Breast05 studies, respectively.
In the neoadjuvant setting, Enhertu, followed by taxane, Roche’s (RHHBY - Free Report) Herceptin (trastuzumab) and Perjeta (pertuzumab) or THP, has now been approved to treat adults with HER2-positive stage II or III breast cancer.
In the adjuvant setting, Enhertu is now approved for treating adults with HER2-positive breast cancer who still have invasive disease following treatment with RHHBY’s Herceptin (with or without Perjeta) and taxane-based therapy.
Year to date, shares of AstraZeneca have lost 1.3% compared with the industry’s decline of 1.6%.
Image Source: Zacks Investment Research
AZN, Daiichi’s Other Development Activities 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.
Enhertu, in combination with Roche’s Perjeta (pertuzumab), is also approved 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 was approved by the FDA for treating a certain type of breast cancer as well as lung cancer in 2025.
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 Zacks Rank & Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold).
Over the past 60 days, 2026 loss per share estimates for Immunocore have narrowed from 97 cents to 16 cents, while estimates for 2027 have moved from a loss of 39 cents per share to earnings of 11 cents during the same time. IMCR stock has lost 19.2% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $2.97, while estimates for 2027 have increased from $2.91 to $4.81 during the same time. LQDA shares have surged 65.1% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.
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AZN, Daiichi's Enhertu Gets FDA Nod for Two New Breast Cancer Settings
Key Takeaways
AstraZeneca (AZN - Free Report) and its Japan-based partner Daiichi Sankyo announced that the FDA has approved their blockbuster antibody-drug conjugate (ADC), Enhertu, for two new breast cancer indications.
The drug is now approved for both the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer. The approvals were based on data from the phase III DESTINY-Breast11 and DESTINY-Breast05 studies, respectively.
In the neoadjuvant setting, Enhertu, followed by taxane, Roche’s (RHHBY - Free Report) Herceptin (trastuzumab) and Perjeta (pertuzumab) or THP, has now been approved to treat adults with HER2-positive stage II or III breast cancer.
In the adjuvant setting, Enhertu is now approved for treating adults with HER2-positive breast cancer who still have invasive disease following treatment with RHHBY’s Herceptin (with or without Perjeta) and taxane-based therapy.
Year to date, shares of AstraZeneca have lost 1.3% compared with the industry’s decline of 1.6%.
Image Source: Zacks Investment Research
AZN, Daiichi’s Other Development Activities 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.
Enhertu, in combination with Roche’s Perjeta (pertuzumab), is also approved 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 was approved by the FDA for treating a certain type of breast cancer as well as lung cancer in 2025.
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 Zacks Rank & Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Immunocore (IMCR - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, 2026 loss per share estimates for Immunocore have narrowed from 97 cents to 16 cents, while estimates for 2027 have moved from a loss of 39 cents per share to earnings of 11 cents during the same time. IMCR stock has lost 19.2% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $2.97, while estimates for 2027 have increased from $2.91 to $4.81 during the same time. LQDA shares have surged 65.1% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.