Telix Pharmaceuticals (ASX:TLX) said the US Food and Drug Administration (FDA) ruled that its New Drug Application for TLX101-CDx, an investigational agent for the imaging of glioma, cannot be approved in its current form, according to a Monday filing with the Australian bourse.
Glioma is a rare and life-threatening type of brain cancer.
In its complete response letter, the FDA stated further confirmatory clinical evidence is necessary to proceed with the application, the filing said.
The company plans to request a hearing with the FDA to review the basis for the decision, per the filing.
Telix Pharmaceuticals shares were down 7% in morning trade on Monday.
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