NUFORMIX PLC

Regulatory Filings • Nov 12, 2025

National Storage Mechanism | Additional information

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 Zach Cohen	+44 (0) 20 3934 6630 [email protected]

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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