Nicox Completes NCX 470 New Drug Application Key Data Generation for Submission as Planned in H1 2026

About this update from Nicox Sa

[{"type":"image","alt":"NICOX SA","displaySize":"","headline":null,"caption":"NICOX SA","className":"","disableSlideshowImg":false,"size":{"original":{"width":290,"height":177,"url":"https://media.zenfs.com/en/globenewswire.com/e5c6c949c0184e4a40b35f1bde81d2f8"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/rPuxYymeI_hpr5ShJmv9pw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTI1NjtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/e5c6c949c0184e4a40b35f1bde81d2f8","width":290,"height":177}},"lazy":false},{"type":"table","headerItems":[],"items":[{"val":[{"colspan":"3","style":"width:614.27px;border-bottom:solid black 1pt;vertical-align:top;","val":[{"type":"text","content":"Press Release ","length":13,"tagName":"p","attribs":{}}]}]},{"val":[{"colspan":"3","style":"width:614.27px;border-top:solid black 1pt;border-bottom:solid black 1pt;text-align:justify;vertical-align:middle;vertical-align:top;","val":[{"type":"text","content":"Nicox Completes NCX 470 New Drug Application Key Data Generation for Submission as Planned in H1 2026","length":106,"tagName":"p","attribs":{}}]}]},{"val":[{"colspan":"3","style":"width:614.27px;vertical-align:top;","val":[{"type":"text","content":"","length":0,"tagName":"p","attribs":{}},{"type":"list","items":[{"val":[{"type":"text","content":"All clinical trial and long-term stability data required for the preparation of the New Drug Applications (NDA) has been generated and analysed","length":143,"tagName":"p"}]},{"val":[{"type":"text","content":"Pre-NDA meeting1 with the U.S. Food and Drug Administration (FDA) in preparation; U.S. NDA submission on-track as planned in H1 2026 ","length":132,"tagName":"p"}]},{"val":[{"type":"text","content":"Submission of NDA in China similarly on track for 2026","length":54,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":329,"olType":false},{"type":"text","content":"December 16, 2025 – release at 7:30 am CETSophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that it has successfully completed generation and analysis of all key data required to support the submission of New Drug Applications (NDAs) in the U.S. and China. Specifically, this includes all clinical trial and long-term stability data, compliant with International Council for Harmonisation (ICH2) guidelines, on batches of both the NCX...

More updates from Nicox Sa