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Biotech Stocks Facing FDA Decision In April 2023

Seres Therapeutics
Seres Therapeutics

Seres Therapeutics Inc.’s (MCRB) investigational oral microbiome therapeutic SER-109 for the prevention of recurrent C. difficile infection is under priority review by the FDA, with a decision due on April 26, 2023.

C. difficile infection is an urgent public threat, with 156 thousand recurrent cases estimated for 2023, according to the CDC. The mortality averages to an estimated 14,000 to 20,000 deaths annually in the U.S.

SER-109, composed of purified Firmicutes spores, if approved, has the potential to become the first-in-class oral microbiome therapeutic to treat adult recurrent CDI patients.

The company has a co-commercialization agreement with Nestlé Health Science to market SER-109 if it is approved.

MCRB closed Thursday’s trading at $5.35, down 4.80%.