Imexhs Raises $1.5M, Dimerix Achieves Primary Endpoint, Mesoblast Receives FDA Support, Imugene Advances CD19 Therapy, Australia

Dimerix (ASX:DXB) has released highly anticipated interim analysis results from its ACTION3 Phase 3 trial of DMX-200 in patients diagnosed with focal segmental glomerulosclerosis (FSGS), demonstrating the achievement of its primary endpoint. The Phase 3 trial has achieved success in its pre-specified interim analysis of the proteinuria (efficacy) endpoint, based on data from the initial 72 randomised patients. The interim analysis indicates that DMX-200 is currently outperforming the placebo in reducing proteinuria, as measured statistically, within a significantly larger participant group compared to its earlier Phase 2 trial involving eight patients. The trial’s Independent Data Monitoring Committee (IDMC) has affirmed no safety concerns related to DMX-200, further enhancing the drug’s safety profile. Mesoblast (ASX:MSB) has announced the US FDA supports an accelerated approval pathway for rexlemestrocel-L, the company’s allogeneic mesenchymal precursor cell (MPC) product, in patients with end-stage ischemic heart failure with reduced ejection fraction (HFrEF) and a left ventricular assist device (LVAD). Clinical stage immuno-oncology company Imugene (ASX:IMU) has announced that its Phase 1 clinical trial of CD19 oncolytic virotherapy drug candidate onCARlytics (on-CAR-19, CF33-CD19 HOV4) has cleared its first cohort within the intratumoural monotherapy arm of the study.