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Nicox Announces Last Patient Completes the NCX 470 Denali Phase 3 Clinical Trial
Globenewswire· 2025-06-30 05:30
Core Insights - Nicox SA has announced the completion of the last patient visit in the Denali Phase 3 clinical trial for NCX 470, a treatment for open-angle glaucoma and ocular hypertension [1][3] - The trial enrolled a total of 696 patients, with topline results expected between mid-August and mid-September 2025 [2][6] - NCX 470 is a novel NO-donating bimatoprost eye drop aimed at lowering intraocular pressure, and the trial compares its efficacy to latanoprost [3][6] Company Overview - Nicox SA is an international ophthalmology company focused on developing innovative solutions for ocular health [5][7] - The company is headquartered in Sophia Antipolis, France, and is listed on Euronext Growth Paris [8] Future Milestones - Topline results from the Denali trial are anticipated in mid-August to mid-September 2025 [6] - A New Drug Application (NDA) submission for NCX 470 in the U.S. is targeted for the first half of 2026, contingent on securing a U.S. partner or necessary funding [5][6] - Initiation of NCX 470 Phase 3 clinical trials in Japan is expected in the second half of 2025 [6]
Nicox: Notice of the Ordinary and Extraordinary Shareholders’ Meeting on June 27, 2025 and appointment of an ad hoc representative
Globenewswire· 2025-06-06 05:30
Company Overview - Nicox SA is an international ophthalmology company focused on developing innovative solutions for vision maintenance and ocular health [7] - The company's lead program is NCX 470, a nitric oxide-donating bimatoprost eye drop aimed at lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension [7] - Nicox's first product, VYZULTA®, is commercially available in the U.S. and over 15 other territories, licensed exclusively to Bausch + Lomb [7] - The company also generates revenue from ZERVIATE® for allergic conjunctivitis, licensed in multiple regions including the U.S. and China [7] Shareholders' Meeting - The Ordinary and Extraordinary General Meeting is scheduled for June 27, 2025, at 2:30 p.m. at the company's headquarters in Sophia Antipolis, France [1] - The agenda and draft resolutions for the meeting were published in the Official Bulletin of Mandatory Legal Announcements [2] - An ad hoc representative has been appointed to represent defaulting shareholders due to difficulties in reaching the required quorum [3] - The ad hoc representative will ensure that the quorum reaches 100% of shares with voting rights [4] Voting Process - Shareholders can vote by proxy, internet, or in person at the meeting [5] - A guide for voting, including internet voting instructions, is available on the company's website [5] - Voting requirements include half the votes in favor for ordinary resolutions and two-thirds in favor for extraordinary resolutions proposed by the Board of Directors [6]
Nicox Announces Results of the Exploratory Whistler Phase 3b Glaucoma Trial
Globenewswire· 2025-05-14 05:30
Press Release Nicox Announces Results of the Exploratory Whistler Phase 3b Glaucoma Trial Several aqueous humor parameters stimulated by nitric oxide were statistically significant or trended in favor of NCX 470; likewise those that respond to prostaglandin analogsEpiscleral venous pressure changes did not show a trend vs. placeboSafety profile is consistent with that of the first Phase 3 trial, Mont BlancNCX 470 intraocular pressure lowering efficacy and safety have already been demonstrated in the Phase ...
Nicox Provides Full Year 2024 Financial Results
Globenewswire· 2025-04-30 05:30
Press Release Nicox Provides Full Year 2024 Financial Results Nicox SA revenue of €7.9 million for full year 2024 Exceptional income of €13.7 million following the transfer of VYZULTA’s future revenue stream to Soleus CapitalNicox SA cash of €10.5 million on 31 December 2024 and the Company estimates it is currently financed into the fourth quarter of 2025 Topline results from NCX 470 second Phase 3 clinical trial, Denali, expected in the third quarter of 2025Ongoing discussions and business development out ...