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Nuformix plc submitted a draft application document to the European Medicines Agency (EMA) on January 13, 2025, regarding an Orphan Drug Designation (ODD) for its lead asset NXP002. A pre-submission meeting with the EMA for this application is scheduled for later in January 2025. Nuformix also confirmed ongoing discussions with a number of potential partners for an out-licence or option agreement for NXP002.
| Date | 13 Jan 2025 |
| Time | 07:00:04 |
| Category | Corporate updates |
| ID | 9865S |
13 January 2025
Nuformix plc
("Nuformix" or the "Company")
NXP002 Orphan Drug Designation Draft Application
Nuformix plc (LSE:NFX), a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing, is pleased to announce 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.
The Company 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.
Enquiries:
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Nuformix plc |
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Dr Dan Gooding, Executive Director
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Via IFC Advisory
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CMC Markets |
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Douglas Crippen |
+44 (0) 20 3003 8632 |
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IFC Advisory Limited |
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Tim Metcalfe Zach Cohen |
+44 (0) 20 3934 6630 |
About Nuformix
Nuformix is a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing. The Company aims to use its expertise in discovering, developing and patenting novel drug forms, with improved physical properties, to develop new products in new indications that are, importantly, differentiated from the original (by way of dosage, delivery route or presentation), thus creating new and attractive commercial opportunities. Nuformix has a pipeline of preclinical assets with potential for significant value and early licensing opportunities.