Event AGN has released its March quarter update. Impact During the quarter, the company made substantial progress with its lead phase 2 clinical trial of ARG-007 in acute ischaemic stroke (AIS), successfully recruiting and dosing the final patient after the quarter end.Results are due in 3Q CY2025. A total of 92 patients with confirmed large vessel occlusion (LVO) ischaemic strokes who underwent endovascular thrombectomy – a procedure to remove the clot from the brain – were enrolled into the study. Patients were randomised 1:1 to receive either an intravenous infusion of ARG-007 or saline placebo. The trial remains blinded until all patients complete their 90-day post stroke follow up. The database will then be locked, and the data unblinded and analysed to assess whether the predefined endpoints have been met. These include: - Primary (Safety): Mortality rate, incidence of serious adverse events (SAEs), and the incidence of symptomatic intracranial haemorrhage.
- Secondary (Efficacy) – Reduction in infarct volume (volume of brain cell injury) between ARG-007 and placebo at 48 hours post administration.
In parallel, the company provided an update on its planned submissions of the FDA Investigational New Drug (IND) and Fast Track applications for ARG-007. AGN is currently conducting a final review of the documents and expects to submit them in the first week of May 2025. Notably, being granted fast track designation could provide substantial incentives for ARG-007 in acute ischaemic stroke. The company ended the quarter with $12.9 million of cash. This should provide AGN a solid funding position to see it through to its phase 2 ischaemic stroke trial results. Action We maintain our Speculative Buy Recommendation and $1.40 Price Target. Our Valuation is exclusively based on ARG-007 in Ischemic stroke, we currently ascribe no value to secondary indications including Hypoxic Ischaemic Encephalopathy (HIE), Traumatic Brain Injury (TBI), or Alzheimer’s Disease (AD). Catalysts Phase 2 (Stroke) Results - 3Q’CY25 / FDA IND | Fast Track Submissions - 2Q’CY25 / Preclinical Data for HIE, TBI, and Alzheimer’s - 2Q’CY25 to 4Q’CY25 | 
(20min delay)