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

Core Insights - Nicox SA has successfully completed the generation and analysis of all key data required for New Drug Applications (NDAs) in the U.S. and China, including clinical trial and long-term stability data for the NCX 470 drug material and finished product [1][5][6] - The company is preparing for a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) and plans to submit the NDA in the first half of 2026, with the Chinese submission expected shortly thereafter [5][6] Company Overview - Nicox SA is an international ophthalmology company focused on developing innovative solutions for vision maintenance and ocular health, with its lead product being NCX 470, a nitric oxide-donating eye drop for lowering intraocular pressure in glaucoma patients [4][7] - The company has licensing agreements for NCX 470 with Ocumension Therapeutics for the Chinese, Korean, and Southeast Asian markets, and with Kowa for the rest of the world [4][6] Future Milestones - The NDA submission for NCX 470 in the U.S. is on track for H1 2026, with the submission in China expected to follow shortly after [5][6] - A Phase 3 clinical program for NCX 470 has been initiated in Japan, managed and financed by Kowa [6]