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.
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