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NCX 470 PDUFA Date set for 30 April 2027

August 27, 2026

What is the news ?

Nicox announces that the FDA has accepted the NDA for NCX 470 for filing and set 30 April 2027 as the PDUFA date for a response on review of the dossier.

What does it mean ?

FDA acceptance represents an important regulatory milestone toward potential approval, which would trigger a milestone payment for Nicox and royalties on sales.

What are the next steps ?

The FDA will continue its review and give their response by the PDUFA date. U.S. launch is targeted for the second half of 2027, subject to FDA approval.
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