Nuformix plc (LON:NFX), a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing, has announced, further to the Company’s announcement on 13 January 2025, that it has submitted an application to the European Medicines Agency regarding Orphan Drug Designation for the Company’s lead asset NXP002, a potential novel inhaled treatment for Idiopathic Pulmonary Fibrosis. The application follows an earlier pre-submission meeting to discuss the Company’s draft application document, following which the Company was advised to proceed.
Following submission, the application is assigned two coordinators:
· one member of the Committee for Orphan Medicinal Products (“COMP”); and
· one scientific administrator from the EMA secretariat.
A 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.
