Business

Nicox Announces Positive Feedback from pre-NDA Meeting with U.S. FDA for NCX 470

Press Release Nicox Announces Positive Feedback from pre-NDA Meeting with U.S. FDA for NCX 470 U.S. NDA submission on track for summer 2026Nicox to receive milestone payment from Kowa upon submission of the NDANDA submission based on Phase 3 clinical data showing NCX 470 lowered intraocular pressure by up to 10mmHg in patients with open-angle glaucoma or ocular hypertension February 16, 2026 – release at 7:30 am CET Sophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), a

articleNicox SaFebruary 16, 20264/company/nicox-sa-1/news/nicox-announces-positive-feedback-from-pre-nda-meeting-with-us-fda-for-ncx-470-1
Nicox Announces Positive Feedback from pre-NDA Meeting with U.S. FDA for NCX 470

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 Announces Positive Feedback from pre-NDA Meeting with U.S. FDA for NCX 470","length":80,"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":"U.S. NDA submission on track for summer 2026","length":44,"tagName":"p"}]},{"val":[{"type":"text","content":"Nicox to receive milestone payment from Kowa upon submission of the NDA","length":71,"tagName":"p"}]},{"val":[{"type":"text","content":"NDA submission based on Phase 3 clinical data showing NCX 470 lowered intraocular pressure by up to 10mmHg in patients with open-angle glaucoma or ocular hypertension ","length":166,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":281,"olType":false},{"type":"text","content":"February 16, 2026 – release at 7:30 am CET Sophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that it has received positive written feedback from its NCX 470 pre-NDA (New Drug Application) meeting with the U.S. Food and Drug Administration (FDA). The minutes confirm that the current data package and the proposed content and format of the proposed NDA application is generally acceptable for submission. The FDA requested complementary pharmacokinetic data, which will be generated in a small number of patient...

More updates from Nicox Sa

NicoxNCXSophia AntipolisNDA submissionintraocular pressureocular hypertensionopen-angle glaucomainternational ophthalmologyU.S. Food and Drug AdministrationNDANew Drug Application