Latest Argenica Therapeutics (ASX:AGN) News

Argenica Therapeutics faces a clinical hold from the US FDA on its stroke drug trial application, though its Australian Phase 2 study remains unaffected and on track.

Argenica Therapeutics has expanded its intellectual property with a new US patent targeting surgically induced strokes, enhancing the commercial potential of its lead drug candidate ARG-007.

Argenica Therapeutics has completed patient dosing in its Phase 2 trial of ARG-007 for acute ischaemic stroke, with topline data expected in Q3 2025. The company also plans to submit its Investigational New Drug application and Fast Track request to the FDA imminently.

Argenica Therapeutics reported a 16% reduction in half-year losses to $1.19 million, buoyed by a 29% increase in other income largely from R&D tax incentives, as it advances its neuroprotective drug development.

Argenica Therapeutics reports compelling preclinical evidence that its lead candidate ARG-007 significantly reduces brain cell damage and inflammation in moderate traumatic brain injury models, marking a promising step toward new TBI treatments.

Argenica Therapeutics has reported compelling preclinical data showing ARG-007 significantly reduces brain cell damage and inflammation in moderate traumatic brain injury, matching levels seen in uninjured controls. This reinforces ARG-007’s potential as a breakthrough neuroprotective therapy.

Argenica Therapeutics has dosed 80% of patients in its Phase 2 stroke trial and gained FDA orphan drug designations for its second candidate, ARG-006. The company reports a cash-positive quarter with $15 million in reserves.

Argenica Therapeutics has received a positive safety review from its independent DSMB for the Phase 2 trial of ARG-007 in acute ischaemic stroke patients, with dosing now 86% complete and full recruitment expected by early Q2 2025.