Nicox: Kowa Files FDA Approval Application for NCX 470, €3M Milestone Achieved
On Wednesday, Kowa submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for NCX 470, Nicox's leading eye drop aimed at reducing intraocular pressure in patients with glaucoma or ocular hypertension. Nicox will receive a milestone payment of 3 million euros, followed by a second installment upon approval.
Innovative Nitric Oxide Eye Drop Under Regulatory Review
NCX 470 (bimatoprost grenod) is an innovative eye drop releasing nitric oxide, designed to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The application filed by Kowa, Nicox's exclusive partner in the United States, is based on the positive results from two Phase 3 clinical trials named Mont Blanc and Denali.
These trials demonstrated that NCX 470 significantly reduced intraocular pressure with a favorable safety profile.
Approval Expected by Mid-2027 with Commercial Launch Before Year-End
Free · Every morning
Technical market signals, before the opening bell.
Bullish and bearish momentum, analyst changes, stocks to watch — automatically computed from Euronext data.
✓ Before 9 AM every morning✓ Euronext data✓ AI-powered analysis
You're in — subscription confirmed!
Your first edition is on its way. Check your spam folder and add us to your contacts.
An error occurred.
Indicative data. No investment advice. Unsubscribe at any time.
Gratuit · chaque matin
Ne ratez plus rien sur vos actions
La tendance derrière les cours. L'essentiel des valeurs Euronext en quelques minutes.
📈les valeurs en mouvement, sur la durée
🎯les objectifs d'analystes qui évoluent
📰les actualités qui font bouger les cours
tendance · 6 séances
✓ C'est fait, vous êtes inscrit !
Votre première édition arrive bientôt. Pensez à vérifier vos spams.
Une erreur est survenue.
CAC 40 · SBF 120 · données indicatives · aucun conseil en investissement · désinscription à tout moment.
The FDA is expected to review the application over a standard 12-month period, leading to an anticipated approval by mid-2027. A commercial launch in the United States is planned before the end of 2027.
Kowa will bear all regulatory and commercial costs related to the development and marketing of NCX 470 in this territory.
An Exclusive Licensing Network Covering Key Markets
NCX 470 is exclusively licensed to Ocumension Therapeutics for China, South Korea, and Southeast Asia, while Kowa holds the rights in Japan and the rest of the world. Phase 3 clinical trials began in Japan in the summer of 2025, and Ocumension is preparing an authorization request in China following this U.S. filing.
In exchange for these exclusive licenses, Nicox will receive regulatory and commercial milestones as well as royalties on global sales.
Nicox a significativement renforcé sa position financière en 2025.
Risks mentioned
Baisse potentielle de la demande pour les nouveaux produits.
Risque de retard dans les soumissions réglementaires.
Opportunities identified
Soumission prévue de la NDA de NCX 470 aux États-Unis en été 2026.
Initiation du programme clinique de phase 3 pour NCX 470 au Japon.
The information presented in this article is provided for informational purposes only and does not constitute an investment recommendation, an incentive to buy or sell a financial asset, or investment advice. Readers are invited to conduct their own research before making any decision.
Investments in the stock market involve risks, including the risk of capital loss. Past performance of an asset or market is no guarantee of future results. Any investment decision should be made taking into account your personal financial situation, objectives and risk tolerance.
