Nicox: FDA Accepts NCX 470 Eye Drop Application, Decision Expected in April 2027
The ophthalmology laboratory based in Biot crosses a regulatory milestone in the approval process for its eye drop intended for glaucoma in the United States. The American agency has set April 30, 2027 as the deadline for its decision.
Nicox announced that the American Food and Drug Administration (FDA) has accepted for examination the marketing authorization request for NCX 470, a candidate also known as K-911 in Kowa publications.
The agency has set April 30, 2027 as the Prescription Drug User Fee Act (PDUFA) date, the deadline by which it will render its decision following review of the file.
According to the company, this acceptance confirms that the file is "sufficiently complete for a formal review" and represents "an important regulatory milestone toward potential approval". The group recalls that a milestone payment is due upon approval.
An Eye Drop Indicated in Open-Angle Glaucoma
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.
NCX 470 is a bimatoprost nitric oxide-donating eye drop (bimatoprost grenod). It is intended for reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
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.
