09:29 AM EST, 12/09/2024 (MT Newswires) -- Seres Therapeutics ( MCRB ) said Monday that the US Food and Drug Administration has granted Breakthrough Therapy designation to its investigational drug SER-155, aimed at reducing bloodstream infections in adults undergoing allogeneic hematopoietic stem cell transplants.

The company said the decision is based on data from a phase 1b trial indicating a 77% reduction in infection risk compared to placebo.

The designation expedites regulatory support and guidance for SER-155, which previously received Fast Track designation, Seres said.

Seres said it plans to meet with the FDA in early 2025 to outline the next trial.

Shares of Seres Therapeutics ( MCRB ) were more than 11% higher in premarket trading.