Shares in Nuformix (LSE:NFX) rose 16% on Wednesday after the company confirmed that European regulators had issued a positive opinion on orphan drug designation for its lead asset, NXP002, in the treatment of idiopathic pulmonary fibrosis (IPF).
The European Medicines Agency’s Committee for Orphan Medicinal Products concluded that NXP002, which delivers the anti-inflammatory drug tranilast via inhalation, has the potential to offer significant clinical benefit for patients with IPF - a rare and often fatal lung disease with limited treatment options.
The committee also noted that NXP002 could be particularly useful when used alongside existing anti-fibrotic therapies or in patients who are unable to tolerate them. Orphan status can offer regulatory and commercial advantages, including market exclusivity, reduced fees and support through development.
Nuformix said it now expects final ratification from the European Commission within 30 days. The company is focused on repurposing drugs for unmet needs in fibrosis and cancer.
The shares rose 0.023p to 0.16p.