Latest Bladder Cancer News

Pacific Edge appoints Simon Flood as chairman designate, aiming to leverage his global investment expertise to navigate Medicare reimbursement challenges for its bladder cancer diagnostic tests in the US.

Pacific Edge reports a $19.1 million net loss for the first half of FY26 amid Medicare coverage loss but positions itself for a Medicare-led recovery with strong clinical evidence and a key advisory committee meeting set for February 2026.

Medicare contractor Novitas plans to convene an expert panel in early 2026 to review coverage for Pacific Edge’s Cxbladder Triage test following the 2025 update to the American Urological Association microhematuria guideline.

The US Centers for Medicare & Medicaid Services has recommended a final reimbursement price of US$1,328 for Pacific Edge’s advanced bladder cancer diagnostic test, Cxbladder Triage Plus, marking a significant increase from earlier proposals.

Pacific Edge has successfully closed its Share Purchase Plan, raising $4.7 million and bringing total new equity to $20.7 million, surpassing initial targets. The capital raise awaits shareholder approval at the upcoming Annual Meeting.

Pacific Edge Limited has opened a $5 million Share Purchase Plan at $0.10 per share, conditional on shareholder approval of a prior $16.1 million Placement. The capital raise aims to extend the company’s cash runway and accelerate US market adoption of its bladder cancer diagnostic tests amid Medicare non-coverage.

Radiopharm Theranostics has initiated dosing in its Phase 1 HEAT trial of 177Lu-RAD202, a novel radiotherapeutic aimed at advanced HER2-positive solid tumors, marking a key step in its clinical development.

Pacific Edge Limited has launched a NZ$20 million capital raise to bolster its cash reserves amid the loss of Medicare coverage for its bladder cancer diagnostic tests, aiming to accelerate US market adoption and support new product development.

Pacific Edge’s Cxbladder Plus and Triage 1 diagnostic tests are set for significant Medicare reimbursement increases, potentially reshaping the company’s US market prospects.

Pacific Edge announces a two-month delay in the Medicare Local Coverage Determination for its genetic oncology tests, extending the effective date to April 24, 2025. This extension follows the company’s active engagement with US regulatory bodies.

Telix Pharmaceuticals has exceeded its full-year 2024 revenue guidance, driven by strong sales of its prostate cancer diagnostic Illuccix® and strategic pipeline advancements.

Pacific Edge faces a significant Medicare reimbursement setback as Novitas finalizes a non-coverage decision for its Cxbladder tests, prompting the company to activate legal challenges and operational restructuring.