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Nicox Completes NCX 470 New Drug Application Key Data Generation for Submission as Planned in H1 2026
Press Release Nicox Completes NCX 470 New Drug Application Key Data Generation for Submission as Planned in H1 2026 All clinical trial and long-term stability data required for the preparation of the New Drug Applications (NDA) has been generated and analysedPre-NDA meeting1 with the U.S. Food and Drug Administration (FDA) in preparation; U.S. NDA submission on-track as planned in H1 2026 Submission of NDA in China similarly on track for 2026 December 16, 2025 – release at 7:30 am CETSophia Anti
About this update from Nicox Sa
1 A pre-NDA meeting is a routine, standard step where a drug company meets with the FDA before submitting its New Drug Application. It serves as a final check to make sure the FDA will have everything it needs for the review. 2 International Council for Harmonisation, http://www.ich.org , whose mission is “to achieve greater harmonisation worldwide to ensure that safe, effective and high-quality medicines are developed and registered.” Attachment