AstraZeneca said the FDA will extend the PDUFA date for its camizestrant NDA review after requesting additional data for the drug in combination with a CDK4/6 inhibitor in 1st-line treatment. The delay is a modest setback for the timeline, though it does not represent a rejection or safety issue based on the information provided. The news is likely to weigh on sentiment modestly but is not a sector-wide event.
AstraZeneca said the FDA will extend the PDUFA date for its camizestrant NDA review after requesting additional data for the drug in combination with a CDK4/6 inhibitor in 1st-line treatment. The delay is a modest setback for the timeline, though it does not represent a rejection or safety issue based on the information provided. The news is likely to weigh on sentiment modestly but is not a sector-wide event.
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