REG - Nuformix PLC - US FDA ODD Application Submitted for NXP002

NuformixAnnouncement

Mon 07:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20250811:nRSK6924Ua&default-theme=true

RNS Number : 6924U  Nuformix PLC  11 August 2025

11 August 2025

 

Nuformix plc

 

("Nuformix" or the "Company")

 

US FDA Orphan Drug Designation Application Submitted 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, further to the Company's announcement on 29 May 2025, that the
European Medicines Agency ("EMA") had granted 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 now submitted an application to the US Food and Drug
Administration ("FDA") for ODD in the United States using FDA Form 4035.

 

The components required for the submission of Form 4035 included:

•     information about Nuformix and the drug product;

•     description of the rare disease or condition of interest, along
with reasons why such therapy is needed;

•     scientific rationale for the use of the drug for the rare disease
or condition;

•     a summary of the regulatory status and marketing history of the
drug in the United States and in other countries; and

•     documentation to demonstrate that the disease or condition meets
qualifications to be a rare disease, defined as a disease or condition
affecting fewer than 200,000 individuals in the United States.

 

The FDA will now review the application and, within 90 days of receipt, issue
a designation letter, a request for more information or a denial.

 

If ODD is granted, Nuformix may be eligible for certain benefits such as 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.

 

The Company is also pleased to confirm that constructive discussions continue
with a number of potential partners with a view to the Company securing an
out-licence or option agreement for NXP002.

 

Dr Dan Gooding, Executive Director, Nuformix, said: "We are very pleased to
have submitted the FDA ODD application following confirmation that Orphan Drug
Designation has been granted for our NXP002 programme in IPF in the EU by the
EMA. Whilst we await the FDA's response we continue 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.

 

 

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCGCGDIXSGDGUC