Welcome to our dedicated page for Seres Therapeutics news (Ticker: MCRB), a resource for investors and traders seeking the latest updates and insights on Seres Therapeutics stock.
Seres Therapeutics, Inc. (Nasdaq: MCRB) is a clinical-stage live biotherapeutics company that regularly issues news about its microbiome-based drug programs, regulatory interactions, and corporate developments. The company focuses on oral live biotherapeutics for medically vulnerable patient populations, particularly adults undergoing allogeneic hematopoietic stem cell transplant (allo-HSCT) and other high-risk groups.
News about Seres often centers on its lead investigational candidate SER-155, including Phase 1b clinical data showing a significant reduction in bacterial bloodstream infections, systemic antibiotic exposure, and febrile neutropenia in allo-HSCT patients compared with placebo. Updates also cover regulatory designations for SER-155, such as Breakthrough Therapy and Fast Track status, and detailed feedback from the U.S. Food and Drug Administration on the design of a planned Phase 2 study.
Investors and followers of MCRB can expect announcements on clinical trial progress, investigator-sponsored studies in areas like immune checkpoint inhibitor–related enterocolitis, and research presentations at major medical meetings. Seres also issues press releases on mechanistic publications for its live biotherapeutics, including VOWST™, and on data generated from its MbTx® platform that support its broader live biotherapeutic strategy.
In addition to R&D updates, Seres publishes news on cost-reduction actions, cash runway expectations, leadership changes, and efforts to secure capital or partnerships to advance its pipeline. For those tracking MCRB, this news feed provides a centralized view of program milestones, scientific data, regulatory interactions, and corporate actions that shape the company’s live biotherapeutics portfolio.
Seres Therapeutics (MCRB) has appointed Dr. Claire M. Fraser to its Board of Directors to bolster its microbiome therapeutic development efforts. Dr. Fraser, a leading figure in microbial genomics, expressed enthusiasm for joining at a pivotal time as the company anticipates the potential approval of its product SER-109 for recurrent C. difficile infection. Following a successful Data Safety Monitoring Board meeting in December, Seres plans to initiate enrollment of Cohort 2 in the SER-155 study in early 2023, aiming to address significant unmet needs in infection protection for medically compromised patients.
Seres Therapeutics, Inc. (Nasdaq: MCRB) announced its participation in the 41st Annual J.P. Morgan Healthcare Conference on January 12, 2023, at 8:15 a.m. PST / 11:15 a.m. EST. An audio webcast will be available on the company's website, with a replay accessible one hour after the event for 21 days. Seres is pioneering microbiome therapeutics, with its SER-109 program showing positive pivotal clinical results for treating C. difficile infections and receiving Breakthrough Therapy and Orphan Drug designations. The company is also advancing SER-155 in a Phase 1b study to protect against infections in stem cell transplant patients.
Seres Therapeutics (Nasdaq: MCRB) is set to host an investor webcast on December 8, 2022, at 8:30 a.m. ET, focusing on the commercialization of SER-109, aimed at treating recurrent C. difficile infection (rCDI). Following FDA acceptance of the Biologics License Application for SER-109, with a PDUFA action date of April 26, 2023, the webcast will discuss clinical data that showed an 88% sustained response in patients, compared to 60% on placebo. Attendees will include management and key medical professionals outlining unmet needs and commercialization strategies.
Seres Therapeutics, Inc. (MCRB) reported third quarter 2022 results and announced that the FDA has accepted its Biologics License Application (BLA) for SER-109 for recurrent C. difficile infection (rCDI) for Priority Review, with a target action date of April 26, 2023. SER-109 demonstrated an 88% sustained clinical response rate against 60% for placebo in Phase 3 trials. The company reported a net loss of $60 million this quarter, down from a net income of $68 million last year, while R&D expenditures rose. As of September 30, 2022, cash reserves stood at approximately $233 million.
Seres Therapeutics, Inc. (Nasdaq: MCRB) will host a conference call and audio webcast on November 2, 2022, at 8:30 a.m. ET, to discuss its third quarter 2022 results and a business update. The company is known for its innovative microbiome therapeutics, notably the SER-109 program, which has received Breakthrough Therapy and Orphan Drug designations from the FDA. SER-109 aims to prevent recurrent C. difficile infections. Seres is also advancing SER-155 in a Phase 1b study for patients with allogeneic transplants and exploring other microbiome therapeutics.
Seres Therapeutics announced that the FDA has accepted their Biologics License Application (BLA) for SER-109, an oral microbiome therapeutic aimed at preventing recurrent C. difficile infections. The application has received Priority Review designation with a PDUFA action date of April 26, 2023. SER-109 demonstrated promising clinical results, with 88% of treated patients free from recurrence at eight weeks post-treatment. Furthermore, Seres has an agreement with Nestlé Health Science for commercialization, including a potential total of $525 million in milestone payments.
Seres Therapeutics (Nasdaq: MCRB) announced positive findings for its investigational therapy SER-109 in preventing recurrent C. difficile infection.Clinical data from the Phase 3 ECOSPOR IV study showed substantial reduction in recurrent infections without serious adverse events, indicating good tolerability among patients with coexisting health issues.FDA has granted SER-109 Breakthrough and Orphan Drug designations, with potential approval expected in the first half of 2023, positioning it as the first oral microbiome therapeutic.
Seres Therapeutics (MCRB) announced positive Phase 3 clinical results for SER-109, an oral microbiome therapeutic, published in JAMA. The study indicates that SER-109 significantly reduces the risk of recurrent C. difficile infection (rCDI) within 24 weeks post-treatment. With approximately 170,000 annual rCDI cases in the U.S., SER-109 aims to enhance the standard of care. The FDA has granted Breakthrough Therapy and Orphan Drug designations for SER-109, and a Biologics License Application has been submitted, with expectations for approval in early 2023.
Seres Therapeutics (Nasdaq: MCRB) announced the presentation of Phase III ECOSPOR IV trial data for its oral microbiome therapeutic SER-109, aimed at preventing recurrent C. difficile infection. This significant data will be showcased at IDWeek 2022 and the ACG 2022 Annual Meeting. SER-109 has received Breakthrough Therapy and Orphan Drug designations from the FDA, indicating its potential to improve treatment standards. The urgent need for effective solutions is underscored by CDC data showing nearly 170,000 annual C. difficile cases in the U.S.
Seres Therapeutics (NASDAQ: MCRB) presented at the World Anti-Microbial Resistance Congress on September 7-8, 2022, discussing advancements in microbiome therapeutics to combat antibiotic-resistant bacterial infections. Chief Scientific Officer Dr. Matthew Henn highlighted Phase 3 data showing that SER-109 reduced antibiotic-resistant pathogens. The company also focuses on SER-155, targeting patients undergoing stem cell transplantation. SER-109's Biologics License Application has been filed with the FDA, with a commercial launch expected in early 2023.