FDA Alignment to Advance ProstACT Global Phase 3 Trial

Telix Pharmaceuticals announced successful alignment with the FDA on the Part 2 protocol design of its ProstACT Global Phase 3 trial for TLX591-Tx in metastatic castration resistant prostate cancer. The FDA confirmed that Part 1 safety data is sufficient to progress Part 2 into the U.S., where the therapeutic candidate will be tested in combination with three standard-of-care therapies. The company plans to submit an IND amendment to initiate Part 2 enrollment in the U.S.