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Zacks Investment Research <\/p>\nAstraZeneca\u00a0AZN 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.<\/p>\n
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.<\/p>\n
The extension follows the FDA\u2019s request for additional data to support the application. This is likely to delay the potential approval of the camizestrant combo.<\/p>\n
The extension of the review timeline for camizestrant comes after the FDA\u2019s 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.<\/p>\n
AZN\u2019s Price Performance <\/p>\n
Year to date, shares of AstraZeneca have increased 2.9% compared with the industry\u2019s rise of 0.1%.<\/p>\n
Zacks Investment Research <\/p>\n
Image Source: Zacks Investment Research<\/p>\n
More on AZN\u2019s Recent Activities With Camizestrant <\/p>\n
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.<\/p>\n
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.<\/p>\n
The FDA had already granted a Breakthrough Therapy designation to the camizestrant combination in the given setting.<\/p>\n
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.<\/p>\n
The camizestrant combo in this setting remains currently under review in Japan and several other countries.<\/p>\n
AZN\u2019s Zacks Rank & Stocks to Consider <\/p>\n
AstraZeneca currently carries a Zacks Rank #3 (Hold).<\/p>\n
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\u00a0the complete list of today\u2019s Zacks #1 Rank (Strong Buy) stocks here.<\/p>\n
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.<\/p>\n
Immunocore\u2019s 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%.<\/p>\n
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.<\/p>\n
Design Therapeutics\u2019 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%.<\/p>\n
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.<\/p>\n
Jasper Therapeutics\u2019 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%.<\/p>\n
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report<\/a><\/p>\n AstraZeneca PLC (AZN) : Free Stock Analysis Report<\/a><\/p>\n Immunocore Holdings PLC Sponsored ADR (IMCR) : Free Stock Analysis Report<\/a><\/p>\n Design Therapeutics, Inc. (DSGN) : Free Stock Analysis Report<\/a><\/p>\n Jasper Therapeutics, Inc. (JSPR) : Free Stock Analysis Report<\/a><\/p>\n This article originally published on Zacks Investment Research (zacks.com).<\/a><\/p>\n