REG - Nuformix PLC - NXP002 ODD Application Submitted

NuformixAnnouncement

28/01/2025 07:00

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RNS Number : 8620U  Nuformix PLC  28 January 2025

28 January 2025

Nuformix plc

("Nuformix" or the "Company")

NXP002 Orphan Drug Designation Application Submitted

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 13 January 2025, that it
has submitted an application to the European Medicines Agency ("EMA")
regarding Orphan Drug Designation ("ODD") for the Company's lead asset NXP002,
a potential novel inhaled treatment for Idiopathic Pulmonary Fibrosis
("IPF").  The application follows an earlier pre-submission meeting to
discuss the Company's draft application document, following which the Company
was advised to proceed.

Following submission, the application is assigned two coordinators:

·      one member of the Committee for Orphan Medicinal Products
("COMP"); and

·      one scientific administrator from the EMA secretariat.

A summary report on the application will be prepared by the coordinators and
circulated to all COMP members and discussed at the COMP's next plenary
meeting.  The COMP will then either adopt a positive opinion or raise a list
of questions and invite a Nuformix representative to an oral explanation at
the next COMP plenary meeting.

The COMP is expected to adopt an opinion by day 90 of the procedure.  It then
forwards this to the European Commission for adoption of a decision.  The
European Commission issues a decision on a COMP opinion within 30 days of
receipt.

Further information regarding applications to the EMA for ODD can be found at
https://www.ema.europa.eu/en/human-regulatory-overview/research-development/orphan-designation-research-development/applying-orphan-designation
(https://www.ema.europa.eu/en/human-regulatory-overview/research-development/orphan-designation-research-development/applying-orphan-designation)

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.

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.

 

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