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3 days ago
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Nicox Extends Existing Flexible Equity Financing
Press Release Nicox Extends Existing Flexible Equity Financing 5 million shares added to the existing equity financing line with Vester Finance NCX 470 Denali confirmatory Phase 3 results expected mid-August to mid-September 2025 August 08, 2025 – release at 7:30 am Sophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced an extension of the PACEO1 equity line of financing entered into with Vester Finance on March 5, 2025, with an additional maximum of 5,000,000 shares (a maximum of 6.43% of the currently issued share capital2 and 4.26% on a fully-diluted basis3). The other terms of the financing, as announced on March 6, 2025, remain unchanged, including the conditions and issue price of the additional on estimated cash and debt positions and expected income from existing agreements, the Company estimates that it is financed into Q3 2026. This cash runway excludes proceeds from the financing announced today but could be further extended depending on the performance of it. If any of the assumptions around estimated income or costs change, this may impact the cash runway of the Company. Under the terms of the amendment signed on August 7, 2025, Vester Finance agreed to subscribe for an additional maximum of up to 5,000,000 additional shares in the Company, at its own initiative, on terms as set out in the Press Release of March 6, 2025. For information purposes only, at the current share price5, the total gross proceeds of the additional shares in this financing would potentially be €3.1 million. Assuming full use of the extension to this equity line, a shareholder holding 1.00% of Nicox's capital before the transaction would see a reduction in his stake to 0.94% of the capital. The Company may terminate this agreement at any time without transaction was authorized by the Chief Executive Officer using a delegation granted by the meeting of the Board of Directors of August 7, 2025, who themselves used the delegation granted by the General Meeting of the shareholders of the Company on June 27, 2025, under the 13th resolution6. There is no requirement for a prospectus to be submitted to the Autorité des marchés financiers (AMF).Vester Finance, who holds approximately 4% of the share capital, is acting in the capacity as a shareholder of Nicox and also as an investor who may sell all or part of the shares over a short or long period time. Risk FactorsRisks factors which are likely to have a material effect on Nicox's business are presented in section 3 of the 'Rapport Annuel 2024' which is available on Nicox's website ( sale of the shares is likely to have an impact on the volatility and liquidity of the stock, as well as on the Company's share price. The number of shares issued under this transaction and admitted to trading will be announced on the Company's website. About Nicox Nicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox's lead program in clinical development is NCX 470 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension licensed to Ocumension Therapeutics for the Chinese, Korean and Southeast Asian markets and to Kowa elsewhere. Nicox also has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, with Glaukos. Nicox's first product, VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, is available commercially in the U.S. and over 15 other territories. Nicox generates revenue from ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets. Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX) and is part of the CAC Healthcare index. For more information Analyst coverage H.C. Wainwright & Co Yi Chen New York, views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports. Contacts NicoxGavin SpencerChief Executive OfficerT +33 (0)4 97 24 53 00communications@ Disclaimer This press release and the information contained therein do not constitute an offer to sell or an offer to subscribe, or a solicitation to purchase or to subscribe Nicox's shares in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The distribution of this press release may be restricted in certain jurisdictions by local law. Persons coming into possession of this press release are required to comply with all local regulations applicable to this press information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking factors which are likely to have a material effect on Nicox's business are presented in section 3 of the 'Rapport Annuel 2024' which is available on Nicox's website ( this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail. Nicox Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, FranceT +33 (0)4 97 24 53 00 1 Programme d'Augmentation de Capital par Exercice d'Options (Capital increase program through exercise of warrants)2 Non-diluted share capital as of 31 July 2025 3 Taking into account the issue of 39,536,771 new shares issuable at the date of this press release on the exercise of stock options (1,187,205 shares), the vesting of restricted stock (4,072,785 shares), the exercise of warrants (20,234,228 shares) and the conversion of bonds convertible into equity (14,042,553 shares)4 The lowest volume-weighted average daily price of the share over the two consecutive trading sessions preceding an exercise request, after applying a maximum discount of 6.5% 5 Closing price of €0.62 on August 7, 20256 Delegation of competence to the Board of Directors to increase the share capital for the benefit of a category of investors without preferential right of subscription of the shareholders Attachment EN_FinancingAugust2025_PR_FINALError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
3 days ago
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Nicox Extends Existing Flexible Equity Financing
Press Release Nicox Extends Existing Flexible Equity Financing 5 million shares added to the existing equity financing line with Vester Finance NCX 470 Denali confirmatory Phase 3 results expected mid-August to mid-September 2025 August 08, 2025 – release at 7:30 am Sophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced an extension of the PACEO1 equity line of financing entered into with Vester Finance on March 5, 2025, with an additional maximum of 5,000,000 shares (a maximum of 6.43% of the currently issued share capital2 and 4.26% on a fully-diluted basis3). The other terms of the financing, as announced on March 6, 2025, remain unchanged, including the conditions and issue price of the additional on estimated cash and debt positions and expected income from existing agreements, the Company estimates that it is financed into Q3 2026. This cash runway excludes proceeds from the financing announced today but could be further extended depending on the performance of it. If any of the assumptions around estimated income or costs change, this may impact the cash runway of the Company. Under the terms of the amendment signed on August 7, 2025, Vester Finance agreed to subscribe for an additional maximum of up to 5,000,000 additional shares in the Company, at its own initiative, on terms as set out in the Press Release of March 6, 2025. For information purposes only, at the current share price5, the total gross proceeds of the additional shares in this financing would potentially be €3.1 million. Assuming full use of the extension to this equity line, a shareholder holding 1.00% of Nicox's capital before the transaction would see a reduction in his stake to 0.94% of the capital. The Company may terminate this agreement at any time without transaction was authorized by the Chief Executive Officer using a delegation granted by the meeting of the Board of Directors of August 7, 2025, who themselves used the delegation granted by the General Meeting of the shareholders of the Company on June 27, 2025, under the 13th resolution6. There is no requirement for a prospectus to be submitted to the Autorité des marchés financiers (AMF).Vester Finance, who holds approximately 4% of the share capital, is acting in the capacity as a shareholder of Nicox and also as an investor who may sell all or part of the shares over a short or long period time. Risk FactorsRisks factors which are likely to have a material effect on Nicox's business are presented in section 3 of the 'Rapport Annuel 2024' which is available on Nicox's website ( sale of the shares is likely to have an impact on the volatility and liquidity of the stock, as well as on the Company's share price. The number of shares issued under this transaction and admitted to trading will be announced on the Company's website. About Nicox Nicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox's lead program in clinical development is NCX 470 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension licensed to Ocumension Therapeutics for the Chinese, Korean and Southeast Asian markets and to Kowa elsewhere. Nicox also has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, with Glaukos. Nicox's first product, VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, is available commercially in the U.S. and over 15 other territories. Nicox generates revenue from ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets. Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX) and is part of the CAC Healthcare index. For more information Analyst coverage H.C. Wainwright & Co Yi Chen New York, views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports. Contacts NicoxGavin SpencerChief Executive OfficerT +33 (0)4 97 24 53 00communications@ Disclaimer This press release and the information contained therein do not constitute an offer to sell or an offer to subscribe, or a solicitation to purchase or to subscribe Nicox's shares in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The distribution of this press release may be restricted in certain jurisdictions by local law. Persons coming into possession of this press release are required to comply with all local regulations applicable to this press information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking factors which are likely to have a material effect on Nicox's business are presented in section 3 of the 'Rapport Annuel 2024' which is available on Nicox's website ( this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail. Nicox Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, FranceT +33 (0)4 97 24 53 00 1 Programme d'Augmentation de Capital par Exercice d'Options (Capital increase program through exercise of warrants)2 Non-diluted share capital as of 31 July 2025 3 Taking into account the issue of 39,536,771 new shares issuable at the date of this press release on the exercise of stock options (1,187,205 shares), the vesting of restricted stock (4,072,785 shares), the exercise of warrants (20,234,228 shares) and the conversion of bonds convertible into equity (14,042,553 shares)4 The lowest volume-weighted average daily price of the share over the two consecutive trading sessions preceding an exercise request, after applying a maximum discount of 6.5% 5 Closing price of €0.62 on August 7, 20256 Delegation of competence to the Board of Directors to increase the share capital for the benefit of a category of investors without preferential right of subscription of the shareholders Attachment EN_FinancingAugust2025_PR_FINALError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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6 days ago
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Nicox's Partner Kowa Initiates NCX 470 Phase 3 Clinical Trial in Japan
Press Release Nicox's Partner Kowa Initiates NCX 470 Phase 3 Clinical Trial in Japan Exclusive Japanese partner Kowa has initiated a Phase 3 safety clinical trial of NCX 470 for the treatment of ocular hypertension in Japan Triggers a €2 million milestone payment to Nicox August 5, 2025 – release at 7:30 am CET Sophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that its exclusive Japanese partner, Kowa, has initiated a Phase 3 safety clinical trial of NCX 470 (also known as K-911) in Japan for the treatment of ocular hypertension, triggering a €2 million milestone payment to Nicox. Only one Phase 3 confirmatory clinical trial in Japanese patients, which will start shortly, plus this safety trial, is required for submission for marketing approval of NCX 470 in Japan. Kowa is responsible for financing and managing the trials under the February 2024 license agreement with Nicox.'Thanks to our continuing collaborative efforts after Kowa received approval to initiate this trial, we are very pleased to announce that the first patient has been enrolled. The Phase 3 trials in Japan are being managed and financed by Kowa, and only one confirmatory Phase 3 trial is expected to be needed to make a submission for marketing approval of NCX 470 in Japan.' said Doug Hubatsch, EVP Scientific Officer of Nicox. The trial announced today is a safety trial and is detailed here: JRCT Safety Trial NCX 470. The 500 patient confirmatory trial is expected to start shortly and is detailed here: JRCT Confirmatory Trial NCX NCX 470NCX 470, Nicox's lead clinical product candidate, is a novel NO-donating bimatoprost eye drop, currently in Phase 3 clinical development programs in the U.S., China and Japan for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Results of Mont Blanc, the first of the Phase 3 clinical trials, have been extensively published and are available on our website. All patients have completed the second Phase 3 clinical trial, Denali, and topline results are expected mid-August to mid-September 2025. Mont Blanc and Denali have been designed to fulfil the regulatory requirements for safety and efficacy Phase 3 trials to support NDA submissions in both the U.S. and in China. A separate Phase 3 clinical program is underway to support Japanese approval. NCX 470 is exclusively licensed to Ocumension Therapeutics in China, Korea and Southeast Asia and to Kowa in the rest of the world. About Nicox Nicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox's lead program in clinical development is NCX 470 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension, licensed to Ocumension Therapeutics for the Chinese, Korean and Southeast Asian markets and to Kowa elsewhere. Nicox also has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, with Glaukos. Nicox's first product, VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, is available commercially in the U.S. and over 15 other territories. Nicox generates revenue from ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets. Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX) and is part of the CAC Healthcare index. For more information Analyst coverage H.C. Wainwright & Co Yi Chen New York, views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports. Contacts NicoxGavin SpencerChief Executive OfficerT +33 (0)4 97 24 53 00communications@ Disclaimer The information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking factors which are likely to have a material effect on Nicox's business are presented in section 3 of the 'Rapport Annuel 2024' which is available on Nicox's website ( this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail. Nicox Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, FranceT +33 (0)4 97 24 53 00 Attachment EN_NCX470KowaFPFVAugust2025_PR_FINAL
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17-07-2025
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Nicox and Kowa Sign Key Agreement worth up to €191.5 million for Exclusive Rights to Glaucoma Treatment NCX 470 in U.S. and all Unlicensed Territories
Press Release Nicox and Kowa Sign Key Agreement worth up to €191.5 million for Exclusive Rights to Glaucoma Treatment NCX 470 in U.S. and all Unlicensed Territories €7.5 million upfront, with total potential development and commercial milestones, depending on Denali trial results, of up to €191.5 million Tiered royalties of up to 20% in the U.S., starting at a minimum of 8%, with tiered high single to double digit royalties elsewhere Kowa will assume full responsibility for the preparation and filing costs of the U.S. NDA for NCX 470, and all future development and commercial costs Provides flexibility for Nicox to explore future growth options July 17, 2025 – release at 7:30 am CET Sophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced the signing of a major new agreement concerning NCX 470 with Kowa Company, Ltd., a Japanese company with a global pharmaceutical business engaged in ground-breaking research, development and marketing. The agreement, worth up to €191.5 million, grants Kowa exclusive rights to develop and commercialize NCX 470, Nicox's nitric oxide (NO)-donating bimatoprost eye drop, for the lowering of intraocular pressure (IOP) in patients with glaucoma or ocular hypertension in the U.S. and all other territories of the world excluding Japan, China, Korea and Southeast Asia. Kowa already has a license to NCX 470 for Japan, where it is preparing to enter a Phase 3 clinical trial. NCX 470 is also licensed to Ocumension Therapeutics for China, Korea and Southeast the terms of the agreement, Nicox will receive an upfront payment of €7.5 million on signing. Additional near-term milestones payments are due on positive topline results from the Denali clinical trial, expected mid-August to mid-September 2025, and on submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), which is currently expected in H2 2026. The total potential development and sales milestones payments will be either €127 million or €191.5 million, depending on the outcome of the Denali clinical trial, plus royalties up to 20% in the U.S. 'This new agreement with our existing partner, Kowa, is a major endorsement of NCX 470's potential in glaucoma and marks a major step forward in strengthening Nicox's financial position. With NCX 470 now globally licensed, we are focused on delivering the Denali Phase 3 results, which we anticipate releasing mid-August to mid-September.' said Gavin Spencer, Chief Executive Officer of Nicox. 'The revenue stream we expect from NCX 470 gives us the flexibility to pursue future growth opportunities, leveraging our expert U.S. ophthalmology development team.''Expanding our collaboration with Kowa, who now becomes our key commercial partner for NCX 470 in the U.S and other major territories, is based on a very successful history of working together. We believe that Kowa has recognised the significant market potential of NCX 470, which we expect to be confirmed with the upcoming results from the Denali Phase 3 trial.' said Emmet Purtill, VP Business Development of Nicox. 'We look forward to continuing to work with Kowa as well as our partner for the Chinese market, Ocumension, to bring NCX 470 to glaucoma patients worldwide.' Details of the AgreementUnder the terms of the exclusive licensing agreement, Kowa is granted rights to develop and commercialize NCX 470 worldwide, excluding the territories already licensed to Ocumension (China, Korea and Southeast Asia) and to Kowa itself (Japan). The collaboration will be managed by a Joint Steering Committee. Key terms include:Milestone PaymentsNicox will receive an upfront payment of €7.5 million upon signing the agreement. Additional near-term milestones payments are due on positive topline results from the Denali Phase 3 clinical trial, expected mid-August to mid-September 2025 and upon submission of an NDA to the FDA, which is currently expected in H2 2026. The total potential development and sales milestones payments will be either €127 million or €191.5 million, depending on the outcome of the Denali clinical trial. Royalty PaymentsKowa will pay Nicox tiered royalties in the U.S. which could reach 20% of net sales. Depending on the results of the Denali clinical trial, royalties due in the U.S. will initially be 8% or 10%. Outside of the U.S., Nicox will receive tiered royalties ranging from single-digit to double-digit percentages. Nicox ObligationsNicox is responsible, at its cost, for generating the remaining development data necessary for the NDA submission to the FDA (principally pharmacokinetic studies) and will support Kowa in preparation of the ObligationsOther than the activities for which Nicox is responsible, Kowa is responsible, at its cost, for all development, regulatory and commercialization activities for NCX 470 in the licensed Runway and Debt RepaymentAs disclosed in the amended bond agreement announced on 14 October 2024, 70% of the upfront payment from Kowa will be used to partially reimburse Nicox's debt, reducing the total debt to €9.6 million. Based on the current cash position (estimated1 at €5.9 million as of 30 June 2025) expected revenue and anticipated milestone payments, Nicox forecasts that it has over 12 months of cash at the date of signature of this agreement. Glaucoma Pharmaceutical MarketThe glaucoma pharmaceutical market is estimated at over $7 billion2, with the U.S. market accounting for around 40%, growing globally at around 3% to 5% CAGR and the number of patients globally is estimated to be around 80 million3. About NCX 470NCX 470, Nicox's lead clinical product candidate, is a novel NO-donating bimatoprost eye drop, currently in Phase 3 clinical development in the U.S., China and Japan (clinical trial authorisation granted for Japan) for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension. Results of Mont Blanc, the first of the Phase 3 clinical trials, have been extensively published and are available on our website. The second Phase 3 clinical trial, Denali, is currently ongoing. The last patient in Denali has completed their final visit, and the results are expected mid-August to mid-September 2025. Mont Blanc and Denali have been designed to fulfil the regulatory requirements for safety and efficacy Phase 3 trials to support NDA submissions in both the U.S. and in China. All remaining NDA-enabling pharmacokinetic and non-clinical studies necessary to support the U.S. NDA filing are on track. A separate Phase 3 program is underway to support Japanese approval, with the first patient expected to be enrolled in H2 2025. NCX 470 is exclusively licensed to Ocumension Therapeutics in China, Korea and Southeast Asia, and to Kowa in the rest of the world. About Nicox Nicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox's lead program in clinical development is NCX 470 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension, licensed to Ocumension Therapeutics for the Chinese, Korean and Southeast Asian markets and to Kowa elsewhere. Nicox also has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, with Glaukos. Nicox's first product, VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, is available commercially in the U.S. and over 15 other territories. Nicox generates revenue from ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets. Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX) and is part of the CAC Healthcare index. For more information Analyst coverage H.C. Wainwright & Co Yi Chen New York, views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports. Contacts NicoxGavin SpencerChief Executive OfficerT +33 (0)4 97 24 53 00communications@ Disclaimer The information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking factors which are likely to have a material effect on Nicox's business are presented in section 3 of the 'Rapport Annuel 2024' which is available on Nicox's website ( this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail. Nicox Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, FranceT +33 (0)4 97 24 53 00 1 Non-audited figure 2 Antiglaucoma Drug Market Size, Trends, Growth Report 2034; Glaucoma Therapeutics Market Report by Drug Class (Prostaglandin Analogs, Beta Blockers, Alpha Adrenergic Agonists, Carbonic Anhydrase Inhibitors, Combination Drugs, and Others), Indication (Open Angle Glaucoma, Angle Closure Glaucoma, and Others); Glaucoma Therapeutics Market Size, Growth, Analysis - 20313 World Glaucoma Association website: World Glaucoma Association » What is glaucoma? Attachment EN_NCX470KowaGlobalLicenseJuly2025_PR_FINAL
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30-06-2025
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Nicox Announces Last Patient Completes the NCX 470 Denali Phase 3 Clinical Trial
Press Release Nicox Announces Last Patient Completes the NCX 470 Denali Phase 3 Clinical Trial Results expected mid-August to mid-September 2025 New Drug Application (NDA) submission in the U.S. targeted for H1 2026 June 30, 2025 – release at 7:30 am CET Sophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that the last patient has completed the Denali Phase 3 trial, evaluating the efficacy and safety of NCX 470, its lead compound, in patients with open-angle glaucoma or ocular hypertension. With this milestone reached, all patients have now completed their treatment and follow-up visits.A total of 696 patients were enrolled in the trial and topline results are expected mid-August to mid-September 2025. 'Reaching the milestone of the last patient last visit in the Denali Phase 3 trial is a great achievement by our clinical sites, our partner Ocumension and the Nicox development team who have continued to drive this trial. I would like to thank everyone who has been involved in the conduct of the Denali trial including our patients, investigators and their staff.' said Doug Hubatsch, Chief Scientific Officer of Nicox 'We look forward to announcing the topline results in the near future, which we expect will further consolidate the profile of NCX 470 and confirm its potential in the glaucoma market. We remain fully focused on completing the clinical development program and preparing for regulatory submissions.'NCX 470, Nicox's lead clinical product candidate, is a novel NO-donating bimatoprost eye drop, currently in Phase 3 clinical development for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The Denali trial is evaluating the IOP lowering efficacy of once-daily dosed NCX 470 ophthalmic solution 0.1% compared to latanoprost ophthalmic solution 0.005% in patients with open-angle glaucoma or ocular hypertension. It is a multi-country (U.S. and China) clinical trial financed equally by Nicox and Ocumension, Nicox's exclusive licensee for China, Korea and Southeast Asia. The Denali trial, together with the already completed Mont Blanc trial, was designed to fulfil the clinical regulatory requirements to support New Drug Application (NDA) submissions of NCX 470 in the U.S. and China. All remaining NDA-enabling pharmacokinetic and non-clinical studies necessary to support the U.S. NDA filing are on track. Subject to securing a U.S. partner, or obtaining the necessary funding, the Company estimates that a NDA for this country NCX 470 could potentially be submitted in H1 2026. Key Future Milestones Denali Phase 3 clinical trial evaluating NCX 470 in patients with open-angle glaucoma or ocular hypertension: Topline results are expected mid-August to mid-September 2025 NCX 470 Phase 3 clinical efficacy and long-term safety trials in Japan: Initiation expected in H2 2025 NCX 470 NDA filing in the United States: expected in H1 2026, subject to securing a U.S. partner, or obtaining the necessary funding About Nicox Nicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox's lead program in clinical development is NCX 470 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension, licensed to Ocumension Therapeutics for the Chinese, Korean and Southeast Asian markets and to Kowa for Japan. Nicox also has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, with Glaukos. Nicox's first product, VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, is available commercially in the U.S. and over 15 other territories. Nicox generates revenue from ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets. Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX) and is part of the CAC Healthcare index. For more information Analyst coverage H.C. Wainwright & Co Yi Chen New York, views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports. Contacts NicoxGavin SpencerChief Executive OfficerT +33 (0)4 97 24 53 00communications@ Disclaimer The information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking factors which are likely to have a material effect on Nicox's business are presented in section 3 of the 'Rapport Annuel 2024' which is available on Nicox's website ( this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail. Nicox Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, FranceT +33 (0)4 97 24 53 00 Attachment EN_NCX470DenaliLPLVJuly2025_PR_FINAL
