Core Insights - Nicox SA has completed additional pre-planned analyses of the NCX 470 Denali Phase 3 clinical trial, confirming sustained efficacy in reducing intraocular pressure (IOP) over 12 months with no new safety observations [1][6][8] - The company is preparing New Drug Applications (NDAs) for NCX 470 in the U.S. and China, with submissions expected in H1 2026 for the U.S. and shortly thereafter for China [2][7] - Nicox plans to present further data at upcoming ophthalmology conferences [3] Clinical Trial Details - The Denali trial is a randomized, multi-regional, double-masked, parallel group study involving 696 patients across 90 sites in the U.S. and China, comparing NCX 470 to latanoprost [5] - NCX 470 demonstrated robust IOP reduction at 6, 9, and 12 months, aligning with trends observed in the Mont Blanc trial [6] Future Plans - The Phase 3 clinical program for NCX 470 in Japan was initiated in summer 2025, managed and financed by Kowa [7] - Nicox's lead product, NCX 470, is a nitric oxide-donating bimatoprost eye drop aimed at treating open-angle glaucoma or ocular hypertension [9]

Core Insights - Nicox SA announced positive results from the Phase 3 Denali trial for NCX 470, demonstrating non-inferiority in lowering intraocular pressure (IOP) compared to latanoprost [1][4][5] - The trial involved 696 patients and showed IOP reductions of 7.9 to 10.0 mmHg for NCX 470 versus 7.1 to 9.8 mmHg for latanoprost [1][5] - NCX 470 is expected to be submitted for New Drug Applications (NDAs) in the U.S. and China in H1 2026 [4][7] Company Overview - Nicox is an international ophthalmology company focused on innovative solutions for ocular health, with NCX 470 as its lead product candidate [16] - The company has established partnerships with Kowa and Ocumension Therapeutics to facilitate NDA preparations and potential future strategies [7][16] - Nicox's revenue streams include royalties from various products, including ZERVIATE® and VYZULTA® [16] Clinical Trial Details - The Denali trial was a randomized, multi-regional, double-masked study comparing NCX 470 0.1% to latanoprost 0.005% [10][11] - The primary efficacy evaluation was based on IOP reduction at multiple time points, confirming the efficacy profile required for regulatory submissions [11][14] - The trial also included a long-term safety extension, with NCX 470 showing a favorable safety profile [6][11] Financial Implications - Nicox will receive a €5 million milestone payment from Kowa based on the trial results, with potential royalties starting at 8% on net sales in the U.S. [12] - Total potential milestones under the agreement with Kowa are valued at €127 million [12] - Royalties of 6% to 12% on net sales are expected from the Chinese, Korean, and Southeast Asian markets due to the partnership with Ocumension [13]