Telix Pharmaceuticals (ASX:TLX) reached alignment with the US Food and Drug Administration (FDA) to advance a phase 3 trial of its TLX591-Tx therapeutic candidate in metastatic castration-resistant prostate cancer, the company said Thursday.

In a type B meeting, the US regulator confirmed that safety data from part one of the study is adequate to allow for progression of part two, the company said.

The launch of part two in the US remains subject to the FDA's review of an investigational new drug amendment, per the statement.