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News

Seres Therapeutics Receives FDA Feedback To Finalize Phase 2 Protocol For SER-155 In Preventing BSIs In Allo-HSCT Patients

Author: Benzinga Newsdesk | September 23, 2025 06:06am

Following recent constructive FDA feedback, Seres anticipates finalizing SER-155 Phase 2 study protocol for the prevention of bloodstream infections in adults undergoing allogeneic hematopoietic stem cell transplant for the treatment of hematological malignancies

Company continues to engage in discussions aimed at obtaining capital and other resources to advance the SER-155 Phase 2 study and is preparing to rapidly operationalize the study, pending securing capital, with interim clinical results anticipated within 12 months of study initiation

Seres is reducing operating costs and decreasing workforce by approximately 25%; based on these actions and current operating plans, the Company expects to extend cash runway well into Q2 2026

CAMBRIDGE, Mass., Sept. 23, 2025 (GLOBE NEWSWIRE) -- Seres Therapeutics, Inc. (NASDAQ:MCRB), (Seres or the Company), a leading live biotherapeutics company, today announced receipt of additional constructive feedback from the U.S. Food and Drug Administration (FDA) on the Phase 2 study protocol for the Company's lead program, SER-155, for the prevention of bloodstream infections (BSIs) in adults undergoing allogeneic hematopoietic stem cell transplant (allo-HSCT). The feedback is expected to support Seres' finalization of the protocol.

The Company continues to engage with multiple parties intending to secure capital and other resources to support advancement of the Phase 2 study of SER-155, which has received Breakthrough Therapy designation, as well as further development of additional live biotherapeutic candidates. The Company also announced the implementation of actions to reduce operating costs, including a reduction in the workforce. As a result of the anticipated cost savings arising from these initiatives and current operating plans, the Company expects to extend its cash runway well into the second quarter of 2026.

Posted In: MCRB

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