Latest Prostate Cancer News

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.

Clarity Pharmaceuticals has signed a significant manufacturing supply agreement with Theragenics to produce copper-64, a key isotope for its upcoming prostate cancer diagnostic, Cu-SAR-bisPSMA. This deal strengthens Clarity’s US supply network ahead of anticipated FDA approval and commercial launch.

Clarity Pharmaceuticals has unveiled compelling Phase II trial results showing its Cu-SAR-bisPSMA PET imaging agent significantly improves detection of prostate cancer recurrence over the current standard. The data, presented at the 2026 European Association of Urology Congress and accepted by European Urology journal, mark a key milestone ahead of regulatory submissions.

Tetratherix Limited has raised approximately $5 million to fast-track its Tutelix prostate spacer into pivotal clinical trials across Australia and the US, aiming to improve radiation therapy for prostate cancer patients.

Clarity Pharmaceuticals has completed enrolment in its Phase III AMPLIFY trial for the Cu-SAR-bisPSMA imaging agent, advancing its bid for FDA approval in prostate cancer diagnostics.

Telix Pharmaceuticals has announced that Part 1 of its ProstACT Phase 3 trial for TLX591-Tx met its primary safety and dosimetry objectives, with no new safety concerns. The study’s success supports ongoing global enrolment in Part 2 and regulatory engagement in the US.