Jul. 2 at 7:39 AM
$TLX Very strong update.
Telix received FDA alignment to advance ProstACT Global Phase 3 Part 2 in the U.S. for TLX591 Tx in metastatic castration resistant prostate cancer.
FDA agreed that Part 1 safety data supports progression and aligned with the company on the Part 2 protocol, statistical plan and safety monitoring.
This matters because TLX is not just a one catalyst biotech. It is already commercial stage, with Q1 revenue of
$230M and FY26 guidance of
$950M to
$970M.
Radiopharma platform, commercial revenue, multiple late stage assets, and now another FDA aligned Phase 3 path.
Long
$TLX and holding. Not financial advice.