Last mentioned: Mar 10, 2026
Interim Analysis
Expected interim efficacy data from the larger global patient cohort.
Part 2 Expansion
Full global enrollment for efficacy endpoints (rPFS and OS) expected to accelerate.
Primary Objectives Met
Announcement that Part 1 successfully validated safety and dosimetry profiles.
Primary Objectives Met
Telix announces Part 1 achieved all primary safety and dosimetry goals.
Part 1 Completion
Enrollment for the safety and dosimetry portion of the study concludes.
Enrollment Milestone
Completion of patient enrollment for the Part 1 SELECT lead-in phase.
Study Initiation
Launch of the ProstACT Global Phase 3 study for mCRPC.
Trial Initiation
ProstACT GLOBAL Phase 3 study begins enrollment.
Telix Pharmaceuticals has announced that Part 1 of its ProstACT GLOBAL Phase 3 study for TLX591 successfully met its primary objectives. This milestone confirms the safety and dosimetry of the company's lead radiopharmaceutical candidate for metastatic prostate cancer, clearing the way for full trial expansion.
Telix Pharmaceuticals has successfully met the primary objectives for Part 1 of its global Phase 3 ProstACT study, validating the safety and dosimetry of its lead therapeutic candidate, TLX591. This milestone de-risks the antibody-based radiopharmaceutical program and clears the path for the trial's continued expansion in metastatic castration-resistant prostate cancer.
Lantheus Holdings and Heron Therapeutics both reported mixed fourth-quarter results for the 2025 fiscal year, balancing immediate commercial headwinds with aggressive long-term guidance. Both companies introduced fiscal year 2026 outlooks, signaling a strategic shift toward post-2025 growth catalysts and pipeline diversification.