American depositary receipts of Telix Pharmaceuticals Limited rose after the Food and Drug Administration approved the company's new drug application for Pixclara, a drug used in brain cancer imaging.
ADRs rose 7.9% to $12.18 in premarket trading on Monday. As of Friday's market close, ADRs were up 51% year to date.
Pixclara is a radioactive diagnostic drug indicated for use with positron emission tomography to differentiate recurrent or progressive gliomas from changes related to treatment.
Gliomas are the most common form of central nervous system cancer, accounting for about 30% of all brain and CNS tumors and 80% of all malignant brain tumors, the company said.
Pixclara is now the first FDA-approved positron emission tomography imaging drug for glioma, the company said.
"Pixclara will provide physicians in the U.S. with more certainty in their diagnoses and greater confidence in their treatment planning for patients," Telix's Chief Executive Kevin Richardson said.