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LONDON - Nuformix plc (LSE:NFX) has received a response from the U.S. Food and Drug Administration (FDA) requesting additional clarification on one specific element of its Orphan Drug Designation (ODD) application for tranilast in Idiopathic Pulmonary Fibrosis (IPF), according to a press release statement issued Wednesday.
The pharmaceutical development company, which focuses on unmet medical needs in fibrosis and oncology through drug repurposing, submitted the ODD application for tranilast, the active substance in its NXP002 lead program that enables inhaled delivery for IPF treatment.
Nuformix plans to respond to the FDA’s request using existing data and information already in the company’s possession. The company noted it had previously addressed a similar query from the European Medicines Agency.
Following the company’s response, the FDA will either issue a designation confirmation letter, request further information, or deny the application.
Dr. Dan Gooding, Executive Director at Nuformix, stated in the press release: "We will respond to FDA using the data we already have on file, having previously had a similar query from the EMA. I remain confident the process will reach a successful conclusion."
The company indicated it continues to progress discussions with potential future licensing partners while awaiting the FDA’s further response.
Nuformix initially announced its application to the FDA for Orphan Drug Designation on August 11, 2025.
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