Confirmation of US ODD for NXP002 in IPF

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	[phone]
IFC Advisory Limited
Tim Metcalfe Zach Cohen	[phone] [e-mail]

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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