FDA Clinical Hold Clouds Argenica’s US Stroke Trial Plans
Argenica Therapeutics has dosed the final patient in its Phase 2 trial for ARG-007 in acute ischaemic stroke, with topline results expected in Q3 2025. Meanwhile, the FDA has placed a clinical hold on its US trial application, introducing uncertainty for US development.
- Final patient dosed in Phase 2 acute ischaemic stroke trial
- Topline Phase 2 data expected in Q3 2025
- FDA places clinical hold on US IND application for ARG-007
- Positive preclinical data supports ARG-007 development in traumatic brain injury
- Secured $1.5 million non-dilutive Australian government funding
Phase 2 Stroke Trial Milestone
Argenica Therapeutics has reached a significant milestone by dosing the final patient in its Phase 2 clinical trial of ARG-007 for acute ischaemic stroke (AIS). Conducted across Australian hospitals, the trial enrolled 92 patients who suffered large vessel occlusion strokes and underwent clot removal procedures. Half received ARG-007, while the other half were given a placebo. The trial remains blinded until all patients complete their 90-day follow-up assessments, with topline data anticipated in the third quarter of 2025.
FDA Clinical Hold Clouds US Prospects
In parallel with its Australian trial, Argenica lodged an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to initiate clinical trials stateside. However, the FDA has placed a clinical hold on this application, citing inadequacies in the non-clinical data package. Due to resource constraints, the FDA has delayed providing a detailed explanation, leaving Argenica and investors in a holding pattern. Importantly, this hold does not affect the ongoing Australian Phase 2 trial.
Expanding ARG-007’s Potential Beyond Stroke
Beyond stroke, Argenica is advancing ARG-007’s development in traumatic brain injury (TBI), a condition affecting millions globally with no approved neuroprotective therapies. Positive preclinical results from a large ferret study demonstrated sustained benefits of ARG-007 up to 14 days post moderate TBI. The company is assembling a Clinical Advisory Committee led by renowned neurologist Clinical Professor Terry O’Brien to guide clinical development in this area.
Strengthening Intellectual Property and Funding
Argenica secured a new US patent extending protection for its neuroprotective peptides in preventing peri-operative strokes during high-risk surgeries. This complements existing patents covering a broad range of neurological conditions. Financially, the company reported $10.5 million in cash reserves as of June 30, 2025, supported by $1.5 million in non-dilutive funding from the Australian Government’s Medical Research Future Fund. Operating cash outflows for the quarter were $2.36 million, primarily directed towards research, clinical trials, and regulatory activities.
Looking Ahead
With the Phase 2 trial dosing complete and topline data on the horizon, Argenica stands at a pivotal juncture. The FDA clinical hold introduces uncertainty for US expansion, but the company’s robust preclinical package and patent portfolio underpin its broader neurological ambitions. Investors will be watching closely as the company navigates regulatory challenges and prepares to unlock the next phase of ARG-007’s clinical journey.
Bottom Line?
Argenica’s upcoming Phase 2 results and FDA developments will be critical to its future trajectory in stroke and brain injury therapies.
Questions in the middle?
- What specific additional data will the FDA require to lift the clinical hold on the US IND?
- How might the FDA delay impact Argenica’s timeline and strategy for US clinical trials?
- Will the positive preclinical TBI data translate into successful clinical outcomes and commercial opportunities?
