FDA Grants Orphan Drug Designation to Nuformix's Pulmonary Fibrosis Treatment
The FDA has granted orphan drug designation to Nuformix PLC's tranilast lysate candidate for treating idiopathic pulmonary fibrosis. The designation provides regulatory incentives including potential market exclusivity in the US. Nuformix is a London-based developer focused on fibrosis and oncology treatments.
The US Food & Drug Administration has granted orphan drug designation to Nuformix PLC's tranilast lysate candidate for the treatment of idiopathic pulmonary fibrosis. The London-based developer of treatments for fibrosis and oncology says the designation provides regulatory incentives, including potential market exclusivity in the United States.
Nuformix PLC, which focuses on developing treatments for fibrosis and oncology, announced the FDA's decision regarding its tranilast lysate candidate. The company's stock rose 15% following the announcement, trading at 0.30 pence with a 12-month range of 0.068p to 0.56p.
Orphan drug designation is granted by the FDA to drugs and biologics intended for the treatment, diagnosis, or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. The designation provides various development incentives, including tax credits for clinical trial costs, exemption from user fees, and potential seven-year market exclusivity upon approval.