FDA Alignment to Advance ProstACT Global Phase 3 Trial
Open PDF
| Stock | TELIX Pharmaceuticals Ltd (TLX.ASX) |
|---|---|
| Release Time | 2 Jul 2026, 10:07 a.m. |
| Price Sensitive | Yes |
This feature provides summaries of price-sensitive announcements for companies followed by users on InvestorPA.
The summaries are generated by large language models so please interpret with care.
Telix Pharmaceuticals Advances ProstACT Global Phase 3 Trial
Key Points
- FDA aligns with Telix on ProstACT Global Phase 3 trial advancement
- FDA approves clinical protocol and statistical framework
- Part 2 of the trial continues recruiting in approved jurisdictions
Full Summary
Telix Pharmaceuticals announced FDA alignment to advance the ProstACT Global Phase 3 trial for its therapeutic candidate TLX591-Tx in metastatic castration-resistant prostate cancer. The FDA confirmed the safety data from Part 1 and agreed on the clinical protocol and statistical framework for Part 2, which involves three standard-of-care combination cohorts. Part 2 is currently recruiting patients in regions with regulatory approval, including Australia, New Zealand, Canada, Türkiye, the United Kingdom, China, Singapore, and South Korea. The trial aims to enroll approximately 490 patients globally.
Sign in to get more information about the company, including guidance changes and other insights.
Sign In