REG - Nuformix PLC - Confirmation of US ODD for NXP002 in IPF

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RNS Number : 9473V  Nuformix PLC  10 March 2026

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10 March 2026

Nuformix plc

("Nuformix" or the "Company")

Confirmation of US Orphan Drug Designation for NXP002 Programme in IPF

Nuformix plc (LSE:NFX), a pharmaceutical development company targeting unmet
medical needs in fibrosis and oncology via drug repurposing, is pleased to
announce that the U.S. Food and Drug Administration ("FDA") has granted Orphan
Drug Designation ("ODD") in Idiopathic Pulmonary Fibrosis ("IPF") for
tranilast lystate, the active drug substance enabled for inhaled delivery in
Nuformix's NXP002 lead programme.

The FDA grants ODD for investigational treatments for rare diseases, such as
IPF, defined as affecting fewer than 200,000 people in the United States.
 ODD qualifies the developer for certain incentives with the goal of
accelerating drug development for patients, including tax credits for clinical
trials or qualified clinical testing costs, a waiver of the Prescription Drug
User Fee Act application fee when a marketing application is submitted, and
the potential to receive seven years of marketing exclusivity upon product
approval.

Dr Dan Gooding, Executive Director, Nuformix, said: "We are delighted to
receive confirmation that Orphan Drug Designation has been granted by the FDA
for our NXP002 programme in IPF, a high-mortality rare disease, in urgent need
of new treatments. The granting of ODD in the United States, alongside the
European EMA ODD granted in April 2025, will be valuable for the potential
future licensing partners we are in discussions with and I look forward to
providing further updates in due course."

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 6632

 Zach Cohen                          nuformix@investor-focus.co.uk (mailto: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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