Latest Prostate Cancer News

Radiopharm Theranostics reported a A$56.3 million comprehensive loss for fiscal 2026, with operating cash outflows rising to A$52.8 million and cash falling to A$4.1 million. The company says further funding is required, while auditors flag a material uncertainty over its ability to continue as a going concern.

Clarity Pharmaceuticals is approaching pivotal Phase III readouts for its prostate cancer imaging agent, backed by AUD178.3 million in liquid assets. The radiopharmaceutical developer remains deeply loss-making, but expanded manufacturing capacity and early clinical signals are pulling its commercial ambitions into sharper focus.

Telix has secured FDA Fast Track designation for BiPASS, its Phase 3 program testing 68Ga-PSMA-PET alongside MRI before prostate biopsy. The milestone may support closer FDA engagement and faster review of a planned NDA, but the indication remains investigational and no BiPASS results were disclosed.

Telix Pharmaceuticals has completed enrollment in its pivotal Phase 3 BiPASS trial for prostate cancer imaging and aligned with the FDA on a pathway that could expand U.S. patient access and reimbursement for its 68Ga-PSMA-PET agents.

Clarity Pharmaceuticals reported a 67% increase in net loss to $107.2 million for FY26, driven by higher R&D spending, while advancing multiple Phase III trials and expanding manufacturing capacity ahead of commercialisation.

Telix Pharmaceuticals returned to profit in H1 2026, driven by strong U.S. sales of Illuccix and Gozellix, a $40 million upfront from Regeneron collaboration, and expanded R&D investment.

LTR Pharma reports a 93% response rate in men seeking convenience and spontaneity with SPONTAN, alongside a 64% response in post-prostatectomy patients, highlighting potential for its rapid-onset intranasal ED treatment in challenging populations.

Clarity Pharmaceuticals has presented compelling clinical evidence that its investigational 64Cu-SAR-bisPSMA diagnostic and 67Cu-SAR-bisPSMA therapeutic candidates outperform current standards in prostate cancer care, positioning the company for regulatory and commercial milestones.

Clarity Pharmaceuticals reveals encouraging early results from the SECuRE trial, with substantial PSA reductions and multiple complete responses at the 8 GBq 67Cu-SAR-bisPSMA dose level in advanced prostate cancer patients.

Clarity Pharmaceuticals bolsters its commercial readiness with a $178.3 million cash reserve and a key US manufacturing agreement, while clinical trials for its prostate cancer imaging and therapeutic agents progress with promising data.

Telix Pharmaceuticals reported a 21% year-on-year revenue jump to US$247 million in Q2 2026, buoyed by strong Precision Medicine sales and a new Regeneron partnership. The company also secured FDA alignment on a pivotal prostate cancer trial and expanded its manufacturing footprint.

Orthocell Ltd delivered a standout FY26 with 44% revenue growth to A$13.2 million, powered by accelerating US sales of its nerve repair product Remplir and a robust cash position supporting further expansion.