AstraZeneca stock falls after FDA panel votes against new cancer drug
shares AstraZeneca It fell on Friday after U.S. regulatory advisers voted against approving the experimental cancer drug.
An advisory panel for the U.S. Food and Drug Administration late Thursday voted 6-3 against AstraZeneca’s oral drug camizantrant for the treatment of a type of breast cancer tumor, citing concerns about the trial design.
The FDA generally follows, but is not bound by, the recommendations of advisory committees.
AstraZeneca’s London-listed shares fell 2% in morning trading.
Members who voted against approving the drug were not convinced that the trial proved that switching to camizestrant early improved long-term survival rates compared to other ways to treat the disease.
AstraZeneca’s shares for the last 12 months.
The vote was based on Phase 3 results of the SERENA-6 clinical trial submitted in 2025. 56% decrease risk of disease progression or death compared with standard care.
Barclays analyst James Gordon said although the vote outcome was negative for the short-term regulatory path, the debate was nuanced.
Gordon said the panel did not discount the drug’s effectiveness or future potential, only concluding that the SERENA-6 study did not prove that moving toward tumor detection before radiographic progression improves long-term outcomes for patients.
The panel did not raise any significant concerns about the drug’s toxicity or overall safety.
AstraZeneca said it will continue to work with the FDA as it completes its review of the camizestrant application. Susan Galbraith, Vice President of Oncology Hematology R&D, said in a statement that the company still believes strongly in the drug.
Jefferies analysts argued that doctors argued that the data did not support an early change in treatment and instead introduced unknown risks by accelerating the order of treatment, potentially shortening the time to otherwise effective options. “Overall, the group characterized SERENA-6 as advocating a very large shift in clinical practice for what they viewed as a modest and uncertain benefit,” analysts wrote. he said.
Still, Jefferies said that wasn’t part of their Buy thesis on the stock and that SERENA-6 was just a small piece of the company’s $80 billion 2030 sales target. They said this shouldn’t be a big deal, other than a potential sensitivity hit.
AstraZeneca shares have risen nearly 25% over the past 12 months, outperforming the UK’s blue-chip index FTSE 100s 20%. There have been a number of positive data readings in recent months, with a catalyst-rich period in 2026 where 11 more data readings are expected.
The company on Wednesday beat sales and profit expectations in the first quarter and said it was on track to meet its medium-term goals.
