Seres Therapeutics announced today that it has been awarded Fast Track Designation by the U.S. Food and Drug Administration (FDA) for its groundbreaking therapeutic candidate. This news has already had a significant impact on the company’s stock, with shares rising 15% to $1.79 in pre-market trading. Over the past month, shares have seen a remarkable 62% increase, although they have fallen 71% over the last year.
Based in Cambridge, Massachusetts, Seres Therapeutics is a prominent developer of microbiology therapeutics. Their latest creation, SER-155, is a microbiome therapeutic designed to prevent gastrointestinal-associated bacterial infections and reduce the incidence of severe acute graft-versus-host disease in immunocompromised patients who undergo stem-cell transplants.
The company anticipates the release of data from the second cohort in a Phase 1b trial of SER-155 during the third quarter. This milestone will provide further insight into the therapeutic’s potential efficacy and safety.
Additionally, Seres Therapeutics reported that sales of VOWST, another FDA-approved microbiome therapeutic, reached approximately $10.4 million in the fourth quarter. However, this figure includes an 11% gross-to-net reduction.
With Fast Track Designation from the FDA and promising developments in their pipeline, Seres Therapeutics continues to make a name for itself in the field of microbiology therapeutics.