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Wednesday, October 26, 2022

Seres: FDA OKs Application for Microbiome Therapeutic SER-109 for Recurrent C. Difficile

 If approved, SER-109 expected to be the first-ever FDA-approved oral microbiome therapeutic –

– PDUFA target action date is April 26, 2023, with anticipated launch soon thereafter 

– FDA advised that they are not currently planning to hold an Advisory Committee Meeting to discuss the SER-109 application –

– Company to hold commercial investor event on December 8, 2022 

https://finance.yahoo.com/news/seres-therapeutics-announces-fda-acceptance-110000650.html

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