Nuformix plc (LSE:NFX), a pharmaceutical development company focusing on fibrosis and oncology through drug repurposing, announced on Monday that it has submitted a draft application for Orphan Drug Designation (ODD) to the European Medicines Agency (EMA) for its lead asset, NXP002.
This drug is being developed as an inhaled treatment for Idiopathic Pulmonary Fibrosis (IPF), a severe respiratory condition with limited therapeutic options.
The draft submission precedes a pre-submission meeting with the EMA, scheduled for later in January 2025. Following the meeting, the company anticipates submitting the formal ODD application, with updates on the review timeline and decision expected shortly thereafter.
In parallel, Nuformix is actively engaged in discussions with potential partners to secure an out-licence or option agreement for NXP002, underscoring its commercial potential.
Nuformix specialises in developing novel drug forms with improved properties to address unmet medical needs. Its pipeline of preclinical assets offers significant value and early licensing opportunities, leveraging innovative approaches to drug repurposing.
Beyfortus study shows sustained reduction in infant RSV hospitalisations across two seasons
AstraZeneca reports positive Phase III results for BREZTRI in uncontrolled asthma
Akeso's AK139 Phase II clinical trials approved in China
Median Technologies secures FDA clearance for AI lung cancer screening software
Insilico Medicine names new vice president, Clinical Development – Oncology
Cizzle Biotechnology secures Canadian patent for lung cancer biomarker test
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
United Therapeutics reports positive phase 1 data for bioengineered liver in acute liver failure
European Commission approves GSK's Arexvy for adults aged 18 and over