Ardea Biosciences (RDEA) Completes Positive End-of-Phase 2 FDA Meetings for Lesinurad

Ardea Biosciences, Inc. (Nasdaq: RDEA), reports completion of formal End-of-Phase 2 meetings with the U.S. Food and Drug Administration (FDA) and successfully reached agreement on the following key aspects of its proposed lesinurad Phase 3 development plan: the overall size and design of the planned Phase 3 clinical studies, the primary endpoints, the total safety database proposed for NDA filing, manufacturing plans for both drug substance and drug product, the preclinical toxicology program and the clinical pharmacology program.

The Company continues to target commencing Phase 3 studies before the end of this year. Lesinurad is Ardea's lead product candidate in development for the chronic treatment of gout.

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