Seres Therapeutics Receives Feedback From FDA on SER-155 Allogeneic Hematopoietic Stem Cell Transplant (allo-HSCT) Development Approach

FDA has provided input on key elements of the SER-155 allo-HSCT clinical development plans including support for the proposed primary efficacy endpoint of reduction in bloodstream infections (BSIs) as of 30 days post HSCT in the next study Seres has submitted clarification questions to FDA and expects a response in the coming weeks, which will inform the proposed protocol for the next SER-155 study in allo-HSCT, which the Company anticipates submitting to FDA in Q2 CAMBRIDGE, Mass., March 03, 2025 (GLOBE N ...