Latest Prostate Cancer News

Orthocell Limited has posted record revenue for FY2026, driven by strong sales growth of Remplir™ and Striate+™ products in Australia, the US, and new international markets, supported by a robust $44.1 million cash position.

Telix Pharmaceuticals has gained FDA alignment to advance Part 2 of its ProstACT Global Phase 3 trial for TLX591-Tx in metastatic castration-resistant prostate cancer, setting the stage for U.S. enrolment pending regulatory approval.

Clarity Pharmaceuticals will present compelling data at EANM 2026 demonstrating its 64Cu-SAR-bisPSMA imaging agent’s superior detection of prostate cancer recurrence and promising therapeutic results from 67Cu-SAR-bisPSMA in advanced disease.

Clarity Pharmaceuticals’ Phase II Co-PSMA trial confirms its Cu-SAR-bisPSMA PET imaging detects more than twice the prostate cancer lesions versus standard care, driving patient management changes. Phase III AMPLIFY recruitment closes, manufacturing deals inked, and cash sits near $198 million.

Radiopharm Theranostics (ASX: RAD) has completed enrolment in its Phase 2b RAD 101 brain metastases imaging trial with interim data showing 90% concordance with MRI, while progressing early-stage trials of therapeutic candidates RAD 202, RV-01, and RAD 402. The company reported a $19.2 million cash balance at quarter end, down from $34.5 million, with a net operating cash outflow of $14.9 million driven by milestone-related R&D and staff costs.

Orthocell’s Q1 FY26 revenue hits $3.2 million, buoyed by growing US sales of its Remplir nerve repair device and a robust $48 million cash position supporting global expansion.

Clarity Pharmaceuticals has secured a major manufacturing deal with Nucleus RadioPharma to produce its next-generation prostate cancer imaging agent, 64Cu-SAR-bisPSMA, ramping up supply ahead of anticipated US market entry.

Telix Pharmaceuticals has announced FDA acceptance of its resubmitted NDA for TLX101-Px (Pixclara®), a PET imaging agent for glioma, setting a PDUFA goal date of September 11, 2026. The agent addresses a significant unmet need in distinguishing recurrent glioma from treatment effects.

Radiopharm Theranostics has received a positive recommendation to escalate the dose of its 177Lu-RAD202 radiotherapeutic in a Phase 1 trial targeting HER2-positive advanced solid tumors, maintaining its timeline to complete dose escalation by year-end 2026.

Radiopharm Theranostics has secured a clinical supply agreement with Siemens Healthineers to manufacture and distribute RAD101, advancing its Phase 3 trial in the U.S. Interim Phase 2b data showed 90% concordance with MRI in detecting brain metastases.

Telix Pharmaceuticals posted an 11% increase in Q1 2026 revenue to US$230 million, reaffirmed full-year guidance, and reported progress in multiple clinical trials including its lead prostate cancer therapy TLX591-Tx.

Radiopharm Theranostics has initiated dosing in its Phase 1 clinical trial of RAD 402, a novel radiolabelled antibody targeting KLK3 in advanced prostate cancer. Early data from the trial’s initial dose levels are expected in the second half of 2026.