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Wednesday, September 18, 2024

Applied Therapeutics AdComm Cancelled

 - Company completed Late-Cycle review meeting with FDA

- FDA no longer intends to hold Advisory Committee meeting

- FDA Review of NDA continues to proceed as planned with PDUFA target action date of November 28, 2024

https://www.globenewswire.com/news-release/2024/09/18/2948089/0/en/Applied-Therapeutics-Provides-Regulatory-Update-on-Govorestat-for-the-Treatment-of-Classic-Galactosemia.html

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