Latest Clinical Testing News

Arovella has moved its off-the-shelf CAR-iNKT therapy ALA-101 into human testing, dosing the first patient in the phase 1 SAPPHIRE trial. The study will now test safety and early signs of activity, with initial data expected in early 2027.

Rhythm Biosciences has widened access to its ColoSTAT blood test, lifted quarterly revenue 64% and advanced reimbursement and NHS evaluation work. The progress sits alongside A$1.803 million in cash and an estimated 1.22 quarters of funding at the current operating burn.

EMVision Medical Devices has taken its pivotal emu™ trial beyond 230 participants while preparing to add acute ischaemic stroke detection to the FDA validation program. The ASX-listed medtech ended September with $18.1 million in cash and $3.7 million in remaining grant funding.

New research from the NEPTUNE cohort has strengthened the biological rationale for Dimerix’s DMX-200 kidney drug, linking CCR2 activity and urinary MCP-1 levels with poorer outcomes in FSGS. The findings support the drug’s mechanism, but do not yet demonstrate Phase 3 efficacy.

Imricor has completed FDA review of the largest module in its US Premarket Approval application, with no deficiencies found in its ablation catheter or irrigation tubing. One operating-system issue remains for the RF-5000 System, but the company says it has already updated the software and is preparing its response.

ReNerve’s October AGM presentation points to sharply higher sales, a growing US distribution network and a broader nerve repair pipeline. The company is also progressing a 240-patient NervAlign clinical study while relying on a $5 million RiverFort funding facility to support expansion.

Rhythm Biosciences has moved ColoSTAT and geneType into commercial use, recording its first sales during FY2026. But with sales revenue of just $85,339, a $5.93 million loss and an auditor-flagged going-concern uncertainty, the next phase will be judged on cash generation and repeat adoption.

Patrys has dosed the first participants in the Phase 1a trial of RLS-2202, moving its intravenous quetiapine formulation into human clinical evaluation. The next test comes in October, when an independent safety committee will decide whether the program can advance to Cohort 2.

Nyrada has secured AU$12.0 million from institutional and sophisticated investors, with a further AU$2.0 million shareholder purchase plan planned, giving the biotech funding to advance its Xolatryp clinical programs. The raise also carries substantial dilution and an unusually large proposed director subscription worth AU$5.125 million, subject to shareholder approval.

Neurotech International has dosed the first patient in its pivotal Phase 3 Beyond Harmony study of NTI164, moving the autism therapy into its most consequential clinical test yet. The trial plans to enrol up to 200 children across six Australian sites, but no Phase 3 efficacy data are available at this stage.

Dimerix has secured Mexican composition of matter protection for its Phase 2-ready kidney drug DMX-652 until June 2041. The grant expands the asset’s patent estate ahead of planned clinical testing in acute kidney injury, although it brings no new clinical data or regulatory approval.

Cleo Diagnostics has appointed Bio-Techne’s CLIA-certified U.S. laboratory Asuragen to run pivotal clinical validation for its pre-surgical ovarian cancer test. The approximately 1,470-sample program is intended to generate the evidence supporting a planned FDA 510(k) submission in the first half of calendar 2027.