REG - Nuformix PLC - NXP002 Orphan Drug Designation Draft Application

NuformixAnnouncement

13/01/2025 07:00

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RNS Number : 9865S  Nuformix PLC  13 January 2025

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:

 

 Nuformix plc
 Dr Dan Gooding, Executive Director  Via IFC Advisory

 CMC Markets
 Douglas Crippen                     +44 (0) 20 3003 8632

 IFC Advisory Limited
 Tim Metcalfe                        +44 (0) 20 3934 6630

 Zach Cohen                          nuformix@investor-focus.co.uk

 

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.

 

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