The BLA is supported by results from a completed phase 3 development programme, including ECOSPOR III (NCT03183128) and ECOSPOR IV (NCT03183141). Additionally, SeresTx’s BLA has been granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) target date of 26th April 2023.
In July 2021, Swiss food giant Nestle paid $175 million upfront for North American co-marketing rights to SER-109. If the oral therapeutic is approved by the FDA, Nestle’s Health Sciences unit will pay SeresTx another $125 million and line up a further possible $225 million in commercial milestones tied to sales targets. The two companies have been working together on this microbiome project since 2016.
