MCRB PDUFA today
Decision announced any time during day- probably after hours. Even very late in the evening
Company Profile
SectorHealth CareOpens in a new window
IndustryBiotechnologyOpens in a new window
Company LocationCambridge, MA
Seres Therapeutics, Inc., a microbiome therapeutics company, develop microbiome therapeutics to treat the modulation of the colonic microbiome. It develops a novel class of biological drugs that are designed to treat by modulating the microbiome to restore health by repairing the function of a disrupted microbiome to a non-disease state. The company's lead product candidate is SER-109, an oral microbiome therapeutic that has completed Phase III clinical trial for the treatment of recurrent Clostridioides difficile infection. Its product pipeline also includes SER-155, an investigational oral fermented microbiome therapeutic which is in Phase 1b clinical trials for the treatment of gastrointestinal infections, bacteremia, and graft versus host disease in immunocompromised patients including patients receiving allogeneic hematopoietic stem cell transplantation. In addition, the company engages in the development of SER-287 which is in Phase 2b and SER-301 that is in Phase 1b to treat ulcerative colitis. Further, it has license Agreement with NHSc Rx License GmbH for the therapeutic products based on the microbiome technology, which includes SER-109 product candidate, which is developed for the treatment of CDI and recurrent CDI; collaboration license agreement with Societe des Produits Nestle S.A. (Nestle) for the development and commercialization of certain product candidates for the treatment and management of CDI and inflammatory bowel disease including UC and Crohn's disease; research collaboration and option agreement with AstraZeneca Inc. for research and develop of microbiome in certain cancers and cancer immunotherapies, including research program for SER-401 targeting various cancers. The company was formerly known as Seres Health, Inc. and changed its name to Seres Therapeutics, Inc. in May 2015. Seres Therapeutics, Inc. was incorporated in 2010 and is headquartered in Cambridge, Massachusetts.
www.serestherapeutics.com
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