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Seres Therapeutics Phase 3 SER-109 Study Meets Main

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Initial Statement of Beneficial Ownership (3) Edgar (US Regulatory) - 10/21/2020 5:00:59 PM
Seres Therapeutics to Present SER-109 Phase 3 ECOSPOR III Study Results at American College of Gastroenterology Annual Scient... Business Wire - 10/12/2020 7:00:00 AM
Amended Statement of Ownership (sc 13g/a) Edgar (US Regulatory) - 10/9/2020 2:17:46 PM
Seres Therapeutics to Present at the Jefferies Next Generation IBD Therapeutics Summit Business Wire - 9/22/2020 7:00:00 AM
Seres Therapeutics to Present at Upcoming Investor Conferences Business Wire - 9/14/2020 7:00:00 AM
Seres Therapeutics Announces U.S. Food and Drug Administration Correspondence Following Positive SER-109 Phase 3 Study Results Business Wire - 9/11/2020 7:00:00 AM
Amended Statement of Ownership (sc 13g/a) Edgar (US Regulatory) - 9/10/2020 10:04:08 AM
Amended Statement of Ownership (sc 13g/a) Edgar (US Regulatory) - 9/9/2020 6:05:05 AM
Amended Statement of Ownership (sc 13g/a) Edgar (US Regulatory) - 9/8/2020 1:29:25 PM
Amended Statement of Beneficial Ownership (sc 13d/a) Edgar (US Regulatory) - 8/19/2020 5:18:18 PM
Free Writing Prospectus - Filing Under Securities Act Rules 163/433 (fwp) Edgar (US Regulatory) - 8/17/2020 4:22:24 PM
Seres Therapeutics, Inc. Announces Closing of Public Offerings of 12,075,000 Shares of Common Stock Business Wire - 8/17/2020 4:15:00 PM
Current Report Filing (8-k) Edgar (US Regulatory) - 8/14/2020 5:10:13 PM
Prospectus Filed Pursuant to Rule 424(b)(5) (424b5) Edgar (US Regulatory) - 8/14/2020 5:07:09 PM
Prospectus Filed Pursuant to Rule 424(b)(5) (424b5) Edgar (US Regulatory) - 8/14/2020 5:04:39 PM
Free Writing Prospectus - Filing Under Securities Act Rules 163/433 (fwp) Edgar (US Regulatory) - 8/13/2020 6:06:59 AM
Free Writing Prospectus - Filing Under Securities Act Rules 163/433 (fwp) Edgar (US Regulatory) - 8/13/2020 6:01:38 AM
Seres Therapeutics, Inc. Announces Pricing of Public Offering of 10,500,000 Shares of Common Stock Business Wire - 8/12/2020 9:39:00 PM
Seres Therapeutics, Inc. Announces Proposed Public Offering of Common Stock Business Wire - 8/11/2020 5:48:00 PM
Prospectus Filed Pursuant to Rule 424(b)(5) (424b5) Edgar (US Regulatory) - 8/11/2020 5:31:17 PM
Automatic Shelf Registration Statement of Securities of Well-known Seasoned Issuers (s-3asr) Edgar (US Regulatory) - 8/11/2020 5:12:12 PM
Current Report Filing (8-k) Edgar (US Regulatory) - 8/10/2020 7:32:26 AM
Seres Therapeutics Announces Positive Topline Results from SER-109 Phase 3 ECOSPOR III Study in Recurrent C. difficile Infect... Business Wire - 8/10/2020 6:30:00 AM
Quarterly Report (10-q) Edgar (US Regulatory) - 7/28/2020 10:02:53 AM
Seres Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Updates Business Wire - 7/28/2020 7:00:00 AM
crudeoil24 Member Level  Monday, 08/10/20 07:14:42 AM
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Seres Therapeutics Phase 3 SER-109 Study Meets Main Endpoint >MCRB
7:06 am ET August 10, 2020 (Dow Jones) Print
By Colin Kellaher

Seres Therapeutics Inc. on Monday said a pivotal phase 3 study of its investigational oral microbiome therapeutic SER-109 for recurrent C. difficile infection met its primary endpoint.

The Cambridge, Mass., developer of biological drugs said SER-109 showed a highly statistically significant 30.2% absolute reduction in the rate of C. difficile infection recurrence compared with placebo, adding that the drug was well tolerated, with a safety profile comparable to placebo.

Seres also said the study's efficacy results exceeded the U.S. Food and Drug Administration's statistical threshold that could allow the single study to fulfill efficacy requirements for a biologics license application, and the company said it plans to meet with the agency to discuss filing for product approval as soon as possible.

C. difficile, an antibiotic-resistant bacterium, is a leading cause of hospital-acquired infection in the U.S.

Shares of Seres, which closed Friday at $4.64, more than tripled to $14.20 in premarket trading Monday.


Write to Colin Kellaher at colin.kellaher@wsj.com

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