Seres Therapeutics Receives FDA Fast Track Designation For SER-155, Cultivated Microbiome Therapeutic Designed To Prevent GI-associated Bacterial Infections
Portfolio Pulse from Benzinga Newsdesk
Seres Therapeutics has been granted FDA Fast Track designation for SER-155, a microbiome therapeutic aimed at preventing gastrointestinal-associated bacterial infections. The Phase 1b placebo-controlled Cohort 2 data for SER-155 is expected to be released in the third quarter of 2024.
January 09, 2024 | 12:14 pm
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Seres Therapeutics, trading as MCRB, received FDA Fast Track designation for its SER-155 therapeutic, which may accelerate the development and review process. Phase 1b results are due in Q3 2024.
The FDA Fast Track designation is a positive regulatory milestone for Seres Therapeutics, indicating that the FDA recognizes the potential of SER-155 to address an unmet medical need. This could potentially lead to expedited development and quicker FDA review, which is typically viewed favorably by investors. The anticipation of Phase 1b results in Q3 2024 also provides a clear timeline for future data that could impact the stock's performance. However, as the data readout is still some time away, the immediate impact may be moderate but positive.
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