Business
NXP002 ODD Application Submitted
NXP002 ODD Application Submitted.
About this update from Nuformix Plc
[{"type":"text","content":"\n\n28 January 2025\nNuformix plc\n(\"Nuformix\" or the \"Company\")\nNXP002 Orphan Drug Designation Application Submitted\nNuformix plc (LSE:NFX), a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing, is pleased to announce, further to the Company's announcement on 13 January 2025, that it has submitted an application to the European Medicines Agency (\"EMA\") regarding Orphan Drug Designation (\"ODD\") for the Company's lead asset NXP002, a potential novel inhaled treatment for Idiopathic Pulmonary Fibrosis (\"IPF\"). The application follows an earlier pre-submission meeting to discuss the Company's draft application document, following which the Company was advised to proceed.\nFollowing submission, the application is assigned two coordinators:\n· one member of the Committee for Orphan Medicinal Products (\"COMP\"); and\n· one scientific administrator from the EMA secretariat.\nA summary report on the application will be prepared by the coordinators and circulated to all COMP members and discussed at the COMP's next plenary meeting. The COMP will then either adopt a positive opinion or raise a list of questions and invite a Nuformix representative to an oral explanation at the next COMP plenary meeting.\nThe COMP is expected to adopt an opinion by day 90 of the procedure. It then forwards this to the European Commission for adoption of a decision. The European Commission issues a decision on a COMP opinion within 30 days of receipt.\nFurther information regarding applications to the EMA for ODD can be found at https://www.ema.europa.eu/en/human-regulatory-overview/research-development/orphan-designation-research-development/applying-orphan-designation\nThe Company is also pleased to confirm that constructive discussions continue with a number of potential partners with a view to the Company securing an out-licence or option agreement for NXP002.\nEnquiries:\n\n\n\n\nNuformix plc\n\n\n \n\n\n\n\nDr Dan Gooding, Executive Director\n \n\n\nVia IFC Advisory\n \n\n\n\n\nCMC Markets\n\n\n\n\n\n\n\nDouglas Crippen\n\n\n+44 (0) 20 3003 8632\n\n\n\n\n\n\n\n\n\n\n\n\nIFC Advisory Limited\n\n\n\n\n\n\n\nTim Metcalfe\nZach Cohen\n\n\n+44 (0) 20 3934 6630\[email protected]...