Ophthalmology company Nicox SA (Euronext Growth Paris:ALCOX) announced on Tuesday that it has completed the generation and analysis of all clinical trial and long-term stability data required to support New Drug Application (NDA) submissions for NCX 470 in the United States and China.
The data package, compliant with International Council for Harmonisation guidelines, covers both drug substance and finished drug product and supports manufacturing, shelf-life and drug metabolism requirements.
The company is preparing for a pre-NDA meeting with the US Food and Drug Administration (FDA), with the US NDA submission on track for the first half of 2026 and the China submission expected shortly thereafter. Preparation of the NDA is being funded by licensing partner Kowa.
Nicox confirmed that the Phase 3 clinical program for NCX 470 in Japan was initiated in summer 2025 and is managed and financed by Kowa.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval