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FDA Declines New Indication for Incyte's (INCY) Zynyz Due to Manufacturing Issues
The FDA has rejected a new indication for Incyte’s cancer treatment, Zynyz, due to manufacturing compliance issues at a third-party site operated by Catalent, a Novo Nordisk unit. Incyte plans to work with the FDA and Catalent to resolve these issues and resubmit the application. Despite this setback, Incyte demonstrates strong financial health with robust margins and growth metrics, and its stock is trading near historical lows.