Update: Telix Pharmaceuticals Says FDA Accepted Brain Cancer Imaging Application; Shares Rise Pre-Bell

(Updates recent stock movement in the last paragraph)Telix Pharmaceuticals (TLX) said Thursday the US Food and Drug Administration accepted its resubmitted new drug application for its investigational glioma imaging agent Pixclara.The regulatory agency assigned a target action date of Sept. 11 to review the imaging system, which is intended to help differentiate between recurrent brain tumors and treatment-related cellular changes in both adult and pediatric patients, the company said.The diagnostic product previously received orphan drug and fast track designations from the FDA, Telix added.Shares of the company were up more than 9% in Friday premarket activity.Price: $10.69, Change: $+0.91, Percent Change: +9.29%

-- (Updates recent stock movement in the last paragraph)

Telix Pharmaceuticals (TLX) said Thursday the US Food and Drug Administration accepted its resubmitted new drug application for its investigational glioma imaging agent Pixclara.

The regulatory agency assigned a target action date of Sept. 11 to review the imaging system, which is intended to help differentiate between recurrent brain tumors and treatment-related cellular changes in both adult and pediatric patients, the company said.

The diagnostic product previously received orphan drug and fast track designations from the FDA, Telix added.

Shares of the company were up more than 9% in Friday premarket activity.

Price: $10.69, Change: $+0.91, Percent Change: +9.29%