FDA Extends Review of AstraZeneca's Camizestrant, Delays Decision to September 2026 (AZN)

The U.S. Food and Drug Administration extended its review of AstraZeneca’s (AZN) new drug application for camizestrant in ESR1-mutated advanced breast cancer, pushing the decision deadline to September 2026, the company disclosed on May 27, 2026. The three-month extension gives regulators additional time to evaluate data submitted for the oral selective estrogen receptor degrader (SERD). Camizestrant is being studied in the pivotal SERENA-6 trial for hormone receptor-positive breast cancers with ESR1 mutations. The delay does not alter AstraZeneca’s 2026 financial guidance, though shares slipped 0.8% in early trading. The drugmaker stated it remains confident in the application and continues to collaborate with the FDA.