Positive Topline Results from SER-109 Phase 3 ECOSPOR III Study in Recurrent C. difficile Infection
– SER-109 met Phase 3 primary endpoint, showing a highly statistically significant 30.2% absolute reduction in the rate of C. difficile infection recurrence compared to placebo –
– SER-109 was well tolerated, with a safety profile comparable to placebo –
– Efficacy results substantially exceeded FDA regulatory guidance to support BLA filing as a single pivotal trial; Company to meet with agency to discuss filing for product approval as soon as possible –
– Positive SER-109 Phase 3 data provide validation for Seres’ microbiome therapeutics platform and further development of its pipeline of product candidates –
IN THE NEWS:
-Schaeffer's Investment Research
- Benzinga
- Investor's Business Daily
- MarketWatch
-Motley Fool
finance.yahoo.c...-103000869.html?guce_refer...
– SER-109 met Phase 3 primary endpoint, showing a highly statistically significant 30.2% absolute reduction in the rate of C. difficile infection recurrence compared to placebo –
– SER-109 was well tolerated, with a safety profile comparable to placebo –
– Efficacy results substantially exceeded FDA regulatory guidance to support BLA filing as a single pivotal trial; Company to meet with agency to discuss filing for product approval as soon as possible –
– Positive SER-109 Phase 3 data provide validation for Seres’ microbiome therapeutics platform and further development of its pipeline of product candidates –
IN THE NEWS:
-Schaeffer's Investment Research
- Benzinga
- Investor's Business Daily
- MarketWatch
-Motley Fool
finance.yahoo.c...-103000869.html?guce_refer...