Nuformix plc (LON:NFX), a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing, has announced that it has submitted a draft application document in advance of a pre-submission meeting with the European Medicines Agency (EMA) regarding an Orphan Drug Designation (ODD) for the Company’s lead asset NXP002, a potential novel inhaled treatment for Idiopathic Pulmonary Fibrosis (IPF). This is the first stage in the process for the Company to potentially secure ODD for NXP002 in IPF.
The pre-submission meeting will occur later in January 2025. The EMA strongly encourages sponsors to request a pre-submission meeting prior to filing an application, the precise timing of which will depend upon feedback received, but could be before the end of January 2025. Upon submission of the application the Company will make a further announcement and confirm the anticipated timelines associated with the review and the EMA’s decision on NXP002’s ODD in IPF.
Nuformix is also pleased to confirm that discussions with potential partners to secure an out-licence or option agreement for NXP002 continue to proceed with a number of parties.
