FDA Alignment to Advance ProstACT Global Phase 3 Trial
MELBOURNE, Australia and INDIANAPOLIS, July 02, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX, “Telix”) today announced the successful outcome of a Type B meeting with the United States (U.S.) Food and Drug Administration (FDA) to review the Part 1 safety and dosimetry data and Part 2 protocol design of the ProstACT Global Phase 3 trial of its therapeutic candidate TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan) in metastatic castration resistant prostate cancer
MELBOURNE, Australia and INDIANAPOLIS, July 02, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX, “Telix”) today announced the successful outcome of a Type B meeting with the United States (U.S.) Food and Drug Administration (FDA) to review the Part 1 safety and dosimetry data and Part 2 protocol design of the ProstACT Global Phase 3 trial of its therapeutic candidate TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan) in metastatic castration resistant prostate cancer.
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