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Thursday, July 13, 2023

Ardelyx: Acceptance of NDA Submission triggers as $2 million milestone payment

 Ardelyx Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that a New Drug Application (NDA) for tenapanor has been accepted for review by China’s Center for Drug Evaluation of the National Medical Products Administration (NMPA) for the control of serum phosphorus in adult patients with chronic kidney disease on hemodialysis. This acceptance triggers a $2 million milestone payment to Ardelyx under the terms of the license agreement between Ardelyx and its collaboration partner in China, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (Fosun Pharma). A potential approval of the NDA submission in China is expected by the end of 2024.

https://www.biospace.com/article/releases/ardelyx-announces-acceptance-of-new-drug-application-for-tenapanor-for-hyperphosphatemia-in-chinaacceptance-of-nda-submission-triggers-as-2-million-milestone-payment-to-ardelyx-by-fosun-pharma/

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