Seres Therapeutics Oral Microbiome Product SER-109 for Recurrent C. Difficile Infection Meets Trial Endpoint SER-109 demonstrated a highly statistically significant 30.2% absolute reduction in the rate of C. difficile infection recurrence compared to placebo. Efficacy results Support BLA filing as a single pivotal trial. The Company will meet with the FDA to discuss filing for product approval as soon as possible. Positive SER-109 Phase 3 …

Seres Therapeutics (MCRB), is microbiome therapeutics platform company. It focuses on developing a novel class of biological drugs that are designed to treat disease by restoring the function of a dysbiotic microbiome, where the natural state of bacterial diversity and function is imbalanced. Seres’ programs comprise: SER-109: This product has completed a Phase 1b/2 study with results showing a clinical benefit in patients with recurring …

but first: Here is some good news from  SAREPTA Yesterday we wrote about BioMarin (BMRN) being granted FDA “Rare Pediatric Disease Designation for its Duchenne potential muscular dystrophy (DMD) drug drisapersen.Today, Sarepta Therapeutics (SRPT) also a developer of RNA-targeted therapeutics has been granted the same for its drug eteplirsen, also a potential treatment for DMD patients who are amenable to skipping exon 51. The Rare …