Nuformix plc (LSE: NFX), a pharmaceutical development company focused on unmet needs in fibrosis and oncology, confirmed on Wednesday that the European Medicines Agency's Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending Orphan Drug Designation (ODD) for its lead programme NXP002 for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

NXP002 leverages tranilast, repurposed for inhaled delivery and has demonstrated potential to offer clinically relevant advantages--both as a complement to existing anti-fibrotic treatments and as an alternative for patients intolerant to those medications.

EMA orphan designation is reserved for therapies targeting life-threatening or chronically debilitating diseases that affect fewer than five in 10,000 people in the EU. The COMP concluded that NXP002 meets these criteria and could offer significant benefit to IPF patients.

The company is awaiting final ratification from the European Commission, expected within 30 days.

Nuformix is advancing a pipeline of preclinical assets via drug repurposing strategies, targeting differentiated dosage forms, delivery methods and therapeutic indications to unlock early licensing and commercial value.