Shares in Nuformix PLC surged 44% in early trading after the company announced it had submitted an application to the European Medicines Agency (EMA) for Orphan Drug Designation for its lead asset, NXP002.
The treatment is an inhaled therapy targeting Idiopathic Pulmonary Fibrosis (IPF), a rare and life-threatening lung condition.
Orphan Drug Designation provides regulatory incentives, including market exclusivity for up to 10 years in the EU, fee reductions, and access to scientific advice.
The application follows a positive pre-submission meeting with the EMA, where the company was advised to proceed.
Nuformix also confirmed ongoing discussions with potential partners to secure a licensing or option agreement for NXP002.
In morning trading, the stock was up 0.051p at 0.17p.