Seres Therapeutics Receives Feedback From FDA on SER-155 Allogeneic Hematopoietic Stem Cell Transplant (allo-HSCT) Development Approach [Yahoo! Finance]
Seres Therapeutics, Inc. (MCRB)
Last seres therapeutics, inc. earnings: 11/5 07:00 am
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Source: Yahoo! Finance
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 NEWSWIRE) -- Seres Therapeutics, Inc. (Nasdaq: MCRB) (Seres or the Company), a leading live biotherapeutics company, today announced that it has received constructive feedback from a Type B Breakthrough Therapy designation engagement with the U.S. Food and Drug Administration (FDA or the agency) regarding the Company's development strategy for its lead live biotherapeutic, SER-155 in patients undergoing allo-HSCT. The FDA provided feedback on important elements of the next study that included a recommendation that it be a Phase 2 and support for a reduction in bloodstream infections as of 30
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MCRB
News
- Seres Therapeutics to Participate in Piper Sandler Healthcare ConferenceGlobeNewswire
- Seres Therapeutics (NASDAQ:MCRB) had its "sell (d)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- Seres Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business UpdatesGlobeNewswire
- Seres Therapeutics to Announce Third Quarter 2025 Financial Results and Business Updates on November 5, 2025GlobeNewswire
- Seres Therapeutics Receives Award of Up to $3.6 Million from CARB-X to Develop Liquid Formulation of SER-155GlobeNewswire
MCRB
Earnings
- 11/5/25 - Beat
MCRB
Sec Filings
- 11/18/25 - Form 4
- 11/18/25 - Form 4
- 11/18/25 - Form 4
- MCRB's page on the SEC website