Latest Clinical Evidence News

OncoSil Medical has secured new distribution agreements across key international markets and achieved critical regulatory milestones, while raising $8 million to fuel its growth in pancreatic cancer treatment.

Neurotech International reports key clinical progress in paediatric neurological disorders, securing FDA orphan drug designation for its Rett Syndrome treatment and advancing pivotal trials for ASD and PANDAS/PANS.

4DMedical reports a remarkable 202% increase in Q2 FY2025 operating revenue, driven by rapid site expansion and key collaborations with leading healthcare providers and the U.S. Department of Defense.

Imugene Limited has secured A$20 million through convertible notes as part of a broader A$46 million capital raise, aiming to advance its promising immuno-oncology pipeline.

OncoSil Medical has achieved a key regulatory milestone with MDR certification from BSI, removing post-market restrictions and streamlining its commercial operations across Europe. This approval also paves the way for renewed efforts to enter the Australian market.

Dimerix Limited has inked a lucrative licensing agreement with Fuso Pharmaceutical for its kidney disease drug DMX-200 in Japan, while completing recruitment for its pivotal Phase 3 ACTION3 trial.

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.

Invex Therapeutics reports encouraging results from its collaboration with Tessara Therapeutics, showing Exenatide’s potential to improve neuronal survival in a 3D human brain model of Alzheimer's disease. The company maintains a stable cash position while exploring new neurological partnerships.

Pacific Edge reports stable test volumes in Q3 FY25 despite Medicare reimbursement uncertainties and seasonal slowdowns, while gearing up for legal action against a flawed Medicare coverage decision.

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.