FDA Alignment to Advance ProstACT Global Phase 3 Trial

研报英文原文证据摘录

FDA Alignment to Advance ProstACT Global Phase 3 Trial

Australia | Biotechnology

Telix EquityJulyResearch2, 2026

COMPANY UPDATEFDA Alignment to Advance ProstACT Global

RATING BUYPhase 3 Trial

PRICE AUD17.02^

US FDA has confirmed that the safety data from Part 1 of the ProstACT

Global study is sufficient to enable progression of Part 2 of the study into the PRICE TARGET | % TO PT AUD27.40 | +61%

US. This news is in line with our timelines and, hence, we make no changes 52W HIGH-LOW AUD25.87 - AUD8.26

to forecasts or price target. ProstACT GLOBAL study has an interim analysis FLOAT (%) | ADV MM (USD) 75.4% | 39.94

of rPFS for futility (likely due 1HCY27E+). MARKET CAP AUD6.2B | $4.3B

TICKER TLX AU

^Prior trading day's closing price unless otherwise

ProstACT GLOBAL phase III study. TLX591 is a radioimmunoconjugate used in the noted.

treatment of prostate cancer (PC), specifically metastatic castration-resistant PC (mCRPC)

that expresses prostate-specific membrane antigen (PSMA). The ProstACT GLOBAL phase

III study is investigating the efficacy and safety of TLX591 in combination with standard of FY (Dec) CHANGE TO JEFe JEF vs CONS

care treatments like androgen receptor pathway inhibitors (ARPIs) or the chemotherapy agent 2026 2027 2026 2027

docetaxel. The primary endpoint of this study is radiographic progression-free survival (rPFS). REV NA NA -27% -29%

EPS NA NA -366% -90%

FDA Alignment to Advance ProstACT Global Trial. TLX announced the successful outcome

of a Type B meeting with the US Food and Drug Administration to review the Part 1 safety 2026 ($) 1Half 2Half FY

and dosimetry data and Part 2 protocol design of the ProstACT Global Phase 3 trial of its EPS 0.00 0.01 0.01

therapeutic candidate TLX591-Tx in mCRPC. The FDA has confirmed that the safety data PREV