NicOx S.A.

Nicox SA announced that the U.S. Food and Drug Administration has accepted the New Drug Application for NCX 470, a nitric oxide-donating bimatoprost eye drop for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension, and set 30 April 2027 as the Prescription Drug User Fee Act (PDUFA) date for a response on review of the dossier. The NDA was submitted by Nicox's exclusive U.S. licensee, Kowa, on June 30, 2026, and a milestone payment will be due upon approval. NCX 470 NDAs are now filed in two key markets, the U.S. and China, with commercial partners Kowa and Ocumension in place for expected launches from H2 2027 onwards. The submission was based on positive results from the Mont Blanc and Denali Phase 3 trials, which demonstrated clinically meaningful reductions in IOP of up to 10 mmHg with a favorable safety profile. A Phase 3 program is ongoing in Japan, and a Q&A is available on Nicox's website.

Nicox SA announced that its exclusive Chinese licensee, Ocumension Therapeutics, has submitted a New Drug Application to China's National Medical Products Administration for NCX 470, a nitric oxide-donating bimatoprost eye drop for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The submission uses the same Phase 3 data from the Mont Blanc and Denali trials that supported the recent U.S. filing, with Chinese clinical sites included in Denali. Ocumension has paid €18 million in license fees for rights in China, Korea, and Southeast Asia, funded 50% of the Denali trial costs, and is among Nicox's principal shareholders; Nicox will receive tiered royalties of 6% to 12% on Ocumension's sales. Approval in China is expected after the U.S. decision, with a typical review timeline of 12 to 18 months, while a Phase 3 program in Japan is underway and U.S. approval is anticipated in summer 2027.

Nicox has submitted a new drug application to the U.S. FDA for NCX 470 in the treatment of open-angle glaucoma and ocular hypertension. The submission was made via its U.S. licensee Kowa and triggered a €3 million milestone payment. NCX 470 is a novel nitric oxide-donating bimatoprost eye drop that demonstrated reduced intraocular pressure and a favorable safety profile in the Phase 3 Mont Blanc and Denali trials. The FDA review is expected to take up to a year, with a response anticipated by mid-2027 and a potential U.S. launch before the end of 2027. Kowa holds exclusive development and commercialization rights in the U.S., Japan, South Korea, and Southeast Asia, while Ocumension Therapeutics is the licensee in China.

Nicox annonce que son licencié exclusif Kowa a soumis une demande d’autorisation de mise sur le marché pour NCX 470 auprès de la FDA américaine, déclenchant un paiement d’étape de 3 millions d’euros. Ce dépôt repose sur les résultats positifs des études de phase 3 Mont Blanc et Denali et vise la réduction de la pression intraoculaire chez les patients atteints de glaucome à angle ouvert ou d’hypertension oculaire. Un paiement supplémentaire est prévu en cas d’approbation, attendue mi-2027 après une période d’examen standard de 12 mois, avec un lancement commercial aux États-Unis avant fin 2027. NCX 470 est également licencié à Ocumension Therapeutics pour la Chine, la Corée du Sud et l’Asie du Sud-Est, et à Kowa pour le Japon et le reste du monde.

Nicox SA announced that its exclusive Chinese licensee Ocumension Therapeutics has received positive pre-submission regulatory feedback from the Chinese Center for Drug Evaluation for NCX 470, an innovative nitric oxide-donating bimatoprost eye drop for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Based on this feedback, Ocumension plans to file a New Drug Application in China shortly after the U.S. NDA submission, which is expected in summer 2026 by Nicox's exclusive U.S. partner Kowa. NCX 470 is licensed to Kowa worldwide except for China, South Korea, and Southeast Asia, where it is licensed to Ocumension. Nicox is eligible for regulatory and sales milestone payments as well as royalties on global sales, with all regulatory and commercialization costs borne by Kowa and Ocumension.