31 January 2024
31 January 2024
Vertex is planning to submit a new drug application to the US Food and Drug Administration (FDA) following the announcement of its Phase III programme meeting its primary endpoint.
The trial met its primary endpoint, showing non-inferiority to Augmentin and demonstrating statistical superiority.
Setting up trial sites in countries with unmet clinical needs can lead to higher patient recruitment and investigator engagement, compared to established trial hubs.
Originally suspended in May 2022, the FDA's decision saw shares in INmune rise by 2% at the market opening.
The final participant is planned to finish dosing on 14 February 2024, with top-line results expected in March 2024.
The study will assess the pharmacokinetics of EC5026, a potential non-opioid analgesic for the treatment of chronic pain.
The trial demonstrated close to dose-proportional pharmacokinetics of IV administered M6229 in sepsis patients.
Merging industry-leading business intelligence & award-winning journalism, this is an unrivalled opportunity for engagement with B2B professionals across a network of 40+ leading media websites.
Steer your business strategy with key data and insights from our latest market research reports and company profiles. Not ready to buy? Start small by downloading a sample report first.
Give your business an edge with our leading industry insights.
