Seres Therapeutics Issues Statement Regarding U.S. Food and Drug Administration Safety Alert Related to Use of Fecal Microbiota Transplantation
Seres Therapeutics, Inc. (MCRB)
Last seres therapeutics, inc. earnings: 11/5 07:00 am
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Source: Business Wire
FDA alert does not impact Seres’ microbiome investigational therapeutic candidates CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Seres Therapeutics, Inc. (Nasdaq: MCRB) (“Seres”) today provided a statement on a safety alert from the U.S. Food and Drug Administration (FDA) regarding bloodstream infections with multi-drug resistant organisms (MDROs) transmitted through fecal microbiota transplantation (FMT). On June 13th, 2019, the agency stated that two immunocompromised adults who received FMT developed invasive infections caused by extended-spectrum beta-lactamase (ESBL)-producing E. coli and that one individual died. The donor stool used was not tested for the pathogen linked to the infection. Seres’ investigational therapeutic candidates, highly purified consortia of spore based commensal bacteria, are fundamentally distinct from FMT and are not impacted by the FDA alert. In contrast to unapproved
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MCRB
Earnings
- 11/2/23 - Beat
MCRB
Sec Filings
- 4/8/24 - Form 4
- 4/8/24 - Form 4
- 4/8/24 - Form 4
- MCRB's page on the SEC website