AstraZeneca shares leap with FDA set to review drug to treat breast cancer
By Steve Goldstein
AstraZeneca shares jumped Wednesday.
AstraZeneca shares rallied on Wednesday after the U.K.-based pharmaceuticals giant and its Japanese partner said the Food and Drug Administration was reviewing one of its drugs to treat breast cancer.
AstraZeneca shares (AZN) (UK:AZN) jumped 7% as it and Daiichi Sankyo (JP:4568), which discovered the drug, said the U.S. regulatory agency will review Enhertu followed by paclitaxel, trastuzumab and pertuzumab to treat stage 2 or stage 3 breast cancer.
The target date for an FDA ruling is May 18, 2026.
The drug is being jointly developed and commercialized by both companies.
A trial showed the combination of drugs demonstrated a statistically significant and clinically meaningful improvement in what's called the pathologic compete response, or pCR, rate when used before surgery in patients with a high risk of early-stage breast cancer.
Approximately one in three patients with early-stage breast cancer are considered high-risk, the companies said.
The two companies saw Enhertu sales of $2.29 billion in the first half of the year, as it already is used in treating some forms of breast cancer.
AstraZeneca shares also climbed on Tuesday in reaction to the Pfizer (PFE) deal cut with the White House to offer lower prices in exchange for tariff relief that lifted the whole sector.
-Steve Goldstein
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10-01-25 1054ET
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