Business
Seres Therapeutics Reports Third Quarter 2022 Financial Results and Provides Business Updates
– Biologics License Application (BLA) for investigational microbiome therapeutic SER-109 for recurrent C. difficile infection (rCDI) accepted for Priority
About this update from Seres Therapeutics, Inc.
[{"type":"text","content":"\n– Biologics License Application (BLA) for investigational microbiome therapeutic SER-109 for recurrent C. difficile infection (rCDI) accepted for Priority Review by U.S. Food and Drug Administration (FDA) –\n\n– PDUFA target action date is April 26, 2023, with anticipated launch soon thereafter –\n\n– Additional SER-109 ECOSPOR III Phase 3 study results published in Journal of the American Medical Association, following initial publication in New England Journal of Medicine –\n\n– SER-109 investor event highlighting rCDI market opportunity and launch preparations to be held December 8, 2022 –\n\n– SER-155 cohort 1 enrollment complete; Company expects pre-planned review of safety data with DMSB before year end, with initial safety and pharmacological cohort 1 data reported in early 2023 –\n\n– Conference call at 8:30 a.m. ET today –\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nSeres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today reported third quarter 2022 financial results and provided business updates.\n\n“Our recent progress, highlighted by the FDA acceptance of our SER-109 BLA for Priority Review, brings us closer to potentially offering a transformative new medicine to individuals caught in the vicious cycle of recurrent C. difficile infection,” said Eric Shaff, President and Chief Executive Officer at Seres. “With a PDUFA date of April 26, 2023, we are closely engaging with the FDA and preparing for a potential product approval and commercial launch shortly thereafter. Alongside our collaborator, Aimmune Therapeutics, Inc., a Nestlé Health Science company, we are making excellent progress advancing educational efforts with physicians and payors in support of broad patient access, pending FDA approval. We look forward to hosting an investor event on December 8th to provide detailed information on the recurrent CDI market opportunity and our launch preparations.\"\n\nProgram and Corporate Updates\n\nSER-109 Phase 3 program in recurrent C. difficile infection: SER-109, an investigational oral, live microbiome therapeutic, achieved its primary endpoint of superiority to placebo in reducing recurrence in patients with rCDI in the ECOSPOR III study. These results, initially published in the New England Journal of Medicine (NEJM), showed that 88% of SER-109 patients achieved a sustained clinical ...