![](https://investorshub.advfn.com/uicon/48355.png?cb=1551739062)
Monday, August 10, 2020 7:14:42 AM
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
New York Yankees and Duke Basketball
Recent MCRB News
- Form DEFM14A - Definitive proxy statement relating to merger or acquisition • Edgar (US Regulatory) • 08/26/2024 08:36:17 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/19/2024 09:45:53 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/19/2024 09:42:58 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/19/2024 09:38:17 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/19/2024 09:36:59 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/19/2024 09:29:45 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 08/15/2024 08:05:26 PM
- Form PREM14A - Preliminary proxy statements relating to merger or acquisition • Edgar (US Regulatory) • 08/15/2024 10:52:59 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/15/2024 10:05:51 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 08/13/2024 09:21:28 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/13/2024 02:38:57 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 08/13/2024 11:08:30 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/13/2024 11:05:33 AM
- Seres Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Updates • GlobeNewswire Inc. • 08/13/2024 11:00:00 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 08/07/2024 12:38:30 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 08/06/2024 09:28:45 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 08/06/2024 09:28:14 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/06/2024 09:27:45 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/06/2024 08:15:03 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 08/06/2024 11:41:04 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/06/2024 11:39:38 AM
- Seres Therapeutics Announces Signing of VOWST™ Asset Purchase Agreement with Nestlé Health Science • GlobeNewswire Inc. • 08/06/2024 11:00:00 AM
- Seres Therapeutics to Announce Second Quarter 2024 Financial Results and Business Update on August 13, 2024 • GlobeNewswire Inc. • 08/06/2024 11:00:00 AM
- Seres Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • GlobeNewswire Inc. • 06/07/2024 08:00:00 PM
- Nestlé Health Science agrees to acquire global rights to VOWST®, product it launched in June 2023 • PR Newswire (US) • 06/06/2024 11:00:00 AM
Element79 Gold Corp Appoints Warren Levy to Board of Directors • ELMGF • Aug 28, 2024 9:51 AM
Integrated Ventures Announces Strategic Entry Into Health & Wellness Industry with Focus on GLP-1 Products • INTV • Aug 28, 2024 8:30 AM
ELEMENT79 ANNOUNCES UPLISTING TO OTCQB VENTURE MARKET • ELMGF • Aug 26, 2024 10:03 AM
North Bay Resources Announces Gold Assays up to 2.2 Ounces per Ton, Fran Gold Project, British Columbia • NBRI • Aug 26, 2024 10:00 AM
PickleJar Unveils Latest Venue Managed Services Innovations in Upcoming Webinar • PKLE • Aug 23, 2024 1:11 PM
Element79 Gold Corp Provides Update on Nevada Portfolio • ELMGF • Aug 23, 2024 8:00 AM