29th May 2025 18:21
(Alliance News) - Nuformix PLC on Thursday said its lead programme, NXP002, has been granted orphan drug designation by the European Medicines Agency for the treatment of idiopathic pulmonary fibrosis.
However, Nuformix shares plunged 26% to 0.12 pence in London at the time of the close.
The London-based developer of treatments for fibrosis and oncology said the designation applies to tranilast, the active compound used in NXP002, which Nuformix is developing for inhaled delivery to treat the rare and deadly lung disease.
The EMA's orphan designation provides a range of incentives for companies developing treatments for conditions affecting fewer than five in 10,000 people in the EU, including 10 years of market exclusivity, reduced fees, and regulatory support,
"We are delighted to receive confirmation that Orphan Drug Designation has been granted for our NXP002 programme in IPF," said Executive Director Dan Gooding. "The EMA award recognises NXP002’s potential to significantly advance IPF treatment…and should significantly support our goal of progressing NXP002 through partnering and further development activities."
The company said it also plans to apply for orphan designation with the US Food & Drug Administration and is in ongoing discussions with potential licensing partners.
By Eva Castanedo, Alliance News reporter
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