Latest Traumatic Brain Injury News

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.

Nyrada Inc. is set to launch a Phase IIa clinical trial of Xolatryp™, aiming to reduce heart muscle damage in acute myocardial infarction patients undergoing PCI. The trial, planned for early 2026, follows promising Phase I safety results and strong preclinical cardioprotection data.

Invex Therapeutics has broadened its collaboration with Tessara Therapeutics to explore Exenatide’s potential in Alzheimer’s disease, while successfully renewing key orphan drug designations in Europe and the US.

Nyrada has successfully dosed and discharged the final participants in its Phase I trial of Xolatryp, reporting no adverse safety signals and setting the stage for Phase II development.

Nyrada has initiated the last cohort of its Phase I trial for Xolatryp, following a clean safety review of the highest dose tested so far. This step sets the stage for critical data that could shape the drug’s next development phase.

EMVision Medical Devices has activated five of six pivotal trial sites for its emu™ bedside brain scanner, advancing towards FDA clearance while launching a parallel innovation study in Australia.

Argenica Therapeutics has reported compelling preclinical results for ARG-007, demonstrating sustained neuroprotection and functional recovery in a ferret model of moderate traumatic brain injury. These findings pave the way for clinical trials targeting a major unmet medical need.

Nyrada’s Phase I clinical trial for its novel drug Xolatryp has cleared safety reviews through four cohorts and will now test higher doses and longer infusions in an expanded trial design.

EMVision Medical Devices has secured a $5 million non-dilutive government grant to accelerate global commercialisation of its innovative First Responder portable brain scanner, aimed at revolutionising pre-hospital stroke and brain injury care.

Nyrada has secured ethics approval to amend its Phase I clinical trial protocol for Xolatryp, allowing testing of higher doses and extended infusion times. This strategic move aims to refine dosing ahead of Phase II trials, with final Phase I results expected by September 2025.

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.

EMVision Medical Devices has enhanced its AI-powered stroke diagnostic algorithm, achieving a notable 95% sensitivity and 80% specificity in recent tests. This progress sets the stage for upcoming pivotal trials and regulatory milestones.