Argenica Therapeutics (ASX:AGN) completes final FDA requested assay for ARG-007
Argenica clears the final FDA safety assay for ARG-007 (xaranetide), paving the way for US clinical trials in acute stroke.
Argenica clears the final FDA safety assay for ARG-007 (xaranetide), paving the way for US clinical trials in acute stroke.
WHO confirms “xaranetide” as the International Nonproprietary Name for Argenica’s lead neuroprotective candidate, ARG-007.
Dr Liz Dallimore, Managing Director of Argenica Therapeutics, spoke to MarketOpen about how an AI enabled reanalysis of the Phase 2 trial has clarified ARG 007’s efficacy in patients with severe acute ischaemic stroke.
With all 92 stroke patients now treated, Argenica’s Phase 2 trial of ARG-007 heads into the critical data lock phase — and the biotech world is watching closely.
With FDA Orphan Drug and Rare Pediatric Disease designations, Argenica Therapeutics (ASX:AGN) strengthens its path forward for ARG-006, a promising treatment for neonatal brain injuries in hypoxic-ischaemic encephalopathy (HIE).
ARG-007’s unique mechanism of action and proven safety profile position it as a strong contender in the acute ischaemic stroke treatment landscape.
Argenica Therapeutics is advancing its novel neuroprotective drug ARG-007 through a promising Phase 2 trial, with no adverse events reported and potential applications in multiple neurological conditions.
Pivotal trials which could position an Australian therapeutic as a leading candidate in the fight against stroke continue on pace.
More preclinical data showing efficacy on an animal model has Argenica further on the path toward clinical trials for traumatic brain injury.
ARG-007 trials will continue unmodified across ten Australian hospitals after no adverse events in the first five patients.