AstraZeneca's London-listed shares fell 1.6% after the FDA's Oncologic Drugs Advisory Committee voted 6‑3 against camizestrant.
The panel said camizestrant showed no meaningful benefit for patients with the targeted breast‑cancer mutation who had not progressed on existing therapy.
Clinical data showed camizestrant delayed disease progression by over six months, delivering median 16‑month progression‑free survival versus 9.2 months with standard care.
Morgan Stanley analysts warned of regulatory overhang and reduced approval likelihood in the SERENA‑6 setting, though approval remains possible.