R&D

Radiopharm Theranostics (ASX:RAD) has announced encouraging interim results from its U.S.-based Phase 2b clinical imaging trial of RAD 101, reporting that 92 per cent of evaluable patients achieved concordance between RAD 101 PET imaging and MRI, the study’s primary endpoint.

Amplia Therapeutics (ASX:ATX) has delivered an update on its clinical progress, announcing an additional confirmed partial tumour response in its ACCENT trial and presenting new data to investors that reinforce the potential of its FAK inhibitor narmafotinib in metastatic pancreatic cancer.

Mesoblast (ASX:MSB) has welcomed new research showing that its allogeneic cell therapy remestemcel-L delivers superior clinical outcomes compared with ruxolitinib for patients with steroid-refractory acute graft versus host disease.

Algorae Pharmaceuticals (ASX:1AI) has taken a significant step forward in AI-enabled drug discovery, announcing the completion of a sweeping set of in silico synergy predictions generated by its upgraded platform, AlgoraeOS v2.

Neuren Pharmaceuticals (ASX:NEU) has secured another significant regulatory milestone in its Rett syndrome program, announcing that partner Acadia Pharmaceuticals has received U.S. FDA approval for DAYBUE STIX, a new dye- and preservative-free powder formulation of trofinetide for oral solution.

Dimerix (ASX:DXB) has reached a significant milestone in its late-stage clinical program, announcing that its global ACTION3 Phase 3 trial of DMX-200 for focal segmental glomerulosclerosis has now completed recruitment and dosing of its target 286 adult patients.

Orthocell (ASX:OCC) has taken an important step in its international expansion plans, submitting a regulatory application to the British Standards Institution seeking approval to commercially distribute its nerve repair device, Remplir, across the European Union and the United Kingdom.

Prescient Therapeutics (ASX:PTX) has taken a significant step forward in its oncology pipeline, announcing that European regulators have authorised the company to begin a Phase 2a clinical trial of PTX-100 in patients with relapsed or refractory Cutaneous T-cell Lymphoma.

Cynata Therapeutics (ASX:CYP) has reached a clinical milestone, completing patient enrolment in its Phase 2 trial of CYP-001, an investigational stem-cell therapy for acute graft-versus-host disease

Argenica Therapeutics (ASX:AGN) has unveiled compelling new evidence that its neuroprotective drug candidate, ARG-007, delivers a significant clinical benefit to patients with the most severe forms of acute ischaemic stroke.

OncoSil Medical’s CEO and Managing Director, Nigel Lange, said, “This first commercial treatment in the UK is an important step forward for OncoSil and for patients living with pancreatic cancer.”

A major step forward in ALS drug development has arrived for Neurizon Therapeutics (ASX:NUZ), with the US Food and Drug Administration clearing the company’s lead candidate, NUZ-001, to enter the HEALEY ALS Platform Trial.