AstraZeneca AZN announced that the FDA will extend the Prescription Drug User Fee Act (PDUFA) date for reviewing the new drug application (NDA) seeking approval of camizestrant in combination with a CDK4/6 inhibitor for the first-line treatment of a certain type of breast cancer.
The NDA is seeking approval for camizestrant in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) for the first-line treatment of HR-positive, HER2-negative advanced breast cancer in patients whose tumors have an emergent ESR1 mutation.
The extension follows the FDA’s request for additional data to support the application. This is likely to delay the potential approval of the camizestrant combo.
The extension of the review timeline for camizestrant comes after the FDA’s Oncologic Drugs Advisory Committee voted 3-6 against recommending approval of the candidate in combination with CDK4/6 inhibitors for the given breast cancer indication in April 2026.
AZN’s Price Performance
Year to date, shares of AstraZeneca have increased 2.9% compared with the industry’s rise of 0.1%.
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More on AZN’s Recent Activities With Camizestrant
Last July, the FDA accepted the NDA for camizestrant in combination with a CDK4/6 inhibitor, which was based on positive data from the pivotal phase III SERENA-6 study.
Data from the same showed that the camizestrant combination reduced the risk of disease progression or death by 56% compared with standard aromatase inhibitor-based therapy and improved median progression-free survival to 16 months from 9.2 months.
The FDA had already granted a Breakthrough Therapy designation to the camizestrant combination in the given setting.
Earlier this month, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the EU approval of camizestrant in combination with a CDK4/6 inhibitor for the treatment of adult patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer upon detection of ESR1 mutation and without disease progression during first-line endocrine therapy in combination with a CDK4/6 inhibitor.
The camizestrant combo in this setting remains currently under review in Japan and several other countries.
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, Design Therapeutics DSGN and Jasper Therapeutics JSPR, each currently carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) 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 to earnings of 11 cents. IMCR stock has lost 15.3% 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, 2026 loss per share estimates for Design Therapeutics have narrowed from $1.46 to $1.36, while the same for 2027 have narrowed from $1.77 to $1.70. DSGN stock has rallied 21.5% year to date.
Design Therapeutics’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 13.48%.
Over the past 60 days, 2026 loss per share estimates for Jasper Therapeutics have narrowed from $3.25 to $1.64, while the same for 2027 have narrowed from $2.19 to $1.09. JSPR stock has plunged 50.1% year to date.
Jasper Therapeutics’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 5.00%.
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This article originally published on Zacks Investment Research (zacks.com).