Seres Therapeutics Announces FDA Orphan Drug Designation for SER-287 in Treatment of Pediatric Ulcerative Colitis
Seres Therapeutics, Inc. (MCRB)
Last seres therapeutics, inc. earnings: 11/5 07:00 am
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Source: Business Wire
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Seres Therapeutics, Inc., (NASDAQ:MCRB) today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to microbiome therapeutic candidate SER-287 for the treatment of Ulcerative Colitis (UC) in pediatric patients. Orphan Drug Designation provides incentives designed to advance drug development for rare diseases or conditions that affect fewer than 200,000 people in the United States. The FDA’s designation of SER-287 follows a review of data which established a medically plausible basis for the use of SER-287 – specifically, the Phase 1b clinical data that highlights the potential of SER-287 as a novel treatment modality for patients suffering from UC. Seres successfully completed a placebo-controlled Phase 1b study of SER-287 in patients with mild-to-moderate UC who were failing current therapies. SER-287 administrati
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MCRB
Earnings
- 11/2/23 - Beat
MCRB
Sec Filings
- 4/23/24 - Form 8-K
- 4/8/24 - Form 4
- 4/8/24 - Form 4
- MCRB's page on the SEC website