REG - Nuformix PLC - Update re. US FDA ODD Application

NuformixAnnouncement

12/11/2025 07:02

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RNS Number : 1283H  Nuformix PLC  12 November 2025

12 November 2025

 

Nuformix plc

 

("Nuformix" or the "Company")

 

Update re. US FDA Orphan Drug Designation Application for NXP002 Programme in
IPF

 

Nuformix plc (LSE:NFX), a pharmaceutical development company targeting unmet
medical needs in fibrosis and oncology via drug repurposing, announces,
further to the Company's announcement on 11 August 2025 regarding the
Company's application to the US Food and Drug Administration ("FDA") for
Orphan Drug Designation ("ODD") in Idiopathic Pulmonary Fibrosis ("IPF") for
tranilast, the active drug substance enabled for inhaled delivery in
Nuformix's NXP002 lead programme, that the Company has received a response
from the FDA requesting further clarification for one specific element of the
application.

 

As previously announced, as part of the ODD application process the FDA can
request further information.  The Company will submit a response to the FDA
as soon as possible using existing data and information in the Company's
possession. Upon further review the FDA will issue a designation confirmation
letter, a request for more information or a denial. Further announcements will
be made in due course, as appropriate.

 

Dr Dan Gooding, Executive Director, Nuformix, said: "We will respond to FDA
using the data we already have on file, having previously had a similar query
from the EMA. I remain confident the process will reach a successful
conclusion and whilst we await the FDA's further response we continue to
progress discussions with potential future licensing partners and will provide
further updates in due course as appropriate."

 

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.

 

About IPF

 

IPF is a chronic lung disease characterised by progressive tissue scarring
that prevents proper lung function. It is a progressive, fatal, age-associated
lung disease affecting approximately three out of every one hundred thousand
people in Europe. IPF typically presents in adults 65 or older and is usually
fatal within two to five years after diagnosis.

 

 

 

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