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Positive Feedback from pre-NDA Meeting with the U.S. FDA

February 16, 2026

What is the news ?

Nicox announced positive feedback from its pre-NDA meeting with the U.S. FDA for NCX 470, confirming that the planned NDA submission remains on track for summer 2026.

What does it mean ?

The FDA’s feedback indicates that the current data package and proposed NDA format are generally acceptable for filing.

What are the next steps ?

Nicox will transfer the NDA to its partner Kowa for submission to the FDA in summer 2026, with the China filing expected shortly afterward.
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