Microbiome therapeutics finally ready to cross finishing line
A US regulatory submission from microbiome company Seres Therapeutics (Nasdaq: MCRB) has been accepted, with an expected decision date of April 26, 2023.
The US Food and Drug Administration will review the firm’s Biologics License Application (BLA) for the investigational microbiome therapeutic SER-109, for the prevention of recurrent C. difficile infection.
The application has also been granted Priority Review designation. The agency has said it is not currently tabling a meeting of its advisory committee to discuss the bid.
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