Latest Clinical Evidence News

Imugene has secured $11.12 million through a placement to advance its allogeneic CAR-T therapy azer-cel after early clinical data showed complete responses in BTKi-resistant lymphoma patients.

Argent BioPharma has struck a global licensing deal for its CannEpil® epilepsy therapy with Splash Beverage Group, securing US$5.5 million upfront through convertible debt forgiveness and retaining manufacturing and intellectual property rights alongside a 15% royalty on future sales.

OncoSil Medical has submitted its Humanitarian Device Exemption application to the FDA for its OncoSil™ device targeting distal cholangiocarcinoma, entering the final review phase with a decision expected within 45 days.

OncoSil Medical secures a spot in the PALACROS consortium, advancing its OncoSil™ device through a cost-efficient Phase II trial targeting unresectable locally advanced pancreatic cancer.

Saluda Medical has obtained FDA approval for its CAP24 surgical paddle lead, a first-of-its-kind device designed for closed-loop spinal cord stimulation, poised to broaden its US market reach and engage new surgical specialties.

4DMedical has cleared a major regulatory hurdle with the Therapeutic Goods Administration approving its CT:VQ™ lung imaging software, paving the way for commercial use across Australia and strengthening its global footprint.

Pacific Edge reported a $35.8 million loss in FY26 amid a 47% revenue drop following Medicare coverage loss, but a draft Medicare policy and $36.1 million capital raise set the stage for recovery.

CONNEQT Health has lodged an FDA Pre-Submission for SphygmoCor Cloud, aiming to shift its arterial health analytics from hardware to a scalable software platform with broad commercial potential.

Island Pharmaceuticals has presented encouraging Phase 2a results for its dengue antiviral ISLA-101, demonstrating safety, effective blood concentrations, and meaningful viral load reductions at the Asia Dengue Summit.

Imricor Medical Systems has submitted the third of four Premarket Approval modules to the FDA, marking a key step towards US approval of its MR-guided cardiac ablation devices.

Pacific Edge has secured NZ$36.1 million through a combination of a NZ$25.4 million placement and a significantly oversubscribed retail offer, reinforcing its strategic position to expand the Cxbladder cancer diagnostic platform.

Entropy Neurodynamics has successfully dosed all six participants in the first cohort of its Phase 2 trial for TRP-8803, an intravenous psilocin therapy targeting Binge Eating Disorder. The study demonstrated controlled psychedelic responses, setting the stage for a Data and Safety Monitoring Board review and topline results expected in July 2026.