- Seres Therapeutics Inc (NASDAQ:MCRB) shares are up Thursday morning as the FDA approved Seres and Nestlé Health Science’s Vowst (fecal microbiota spores, live-brpk), an orally administered microbiota-based therapeutic to prevent recurrence of C. difficile Infection (CDI) in adults after antibiotic treatment for recurrent CDI (rCDI).
- VOWST is not indicated for the treatment of CDI.
- Based on data from the U.S. Centers for Disease Control and Prevention (CDC), the companies estimate 156,000 episodes in the U.S. in 2023.
- In a pivotal Phase 3 study, Vowst, previously dubbed SER-109, helped 88% of patients clear infections and reduce recurrences at eight weeks, compared with 60% of patients who got a placebo.
- In addition, at six months post-treatment, 79% of the VOWST group were demonstrated to be recurrence-free, compared to 53% in the placebo group.
- In July 2021, Seres and Nestlé Health Science agreed to commercialize Vowst in the U.S. and Canada jointly.
- Seres is due to receive a $125 million milestone payment from Nestlé Health Science associated with the FDA approval of Vowst.
- Upon Vowst commercialization, each company will be entitled to share equally in commercial profits and losses.
- Price Action: MCRB shares are up 13.12% at $7.24 during the premarket session on the last check Thursday.
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