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.
The 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.
Further 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
Nuformix 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.
