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 (Nasdaq: MCRB) has completed its rolling submission for a Biologics License Application (BLA) to the FDA for SER-109, targeting recurrent C. difficile infections. With FDA Breakthrough Therapy designation, SER-109 could launch in the first half of 2023, aiming to be the first FDA-approved oral microbiome therapeutic. The submission is based on promising Phase 3 trial results showing an 88% sustained response rate compared to 60% for placebo. Seres has partnered with Aimmune Therapeutics for commercialization, receiving an upfront payment of $175 million.
Seres Therapeutics, Inc. (Nasdaq: MCRB), a leader in microbiome therapeutics, announced that CEO Eric Shaff will participate in the Canaccord Genuity 42nd Annual Growth Conference on August 10 at 12:30 p.m. ET. An audio webcast of the event will be accessible on the company's website, with a replay available for 21 days.
Seres is known for its SER-109 program, the first microbiome drug candidate to achieve positive pivotal clinical results, aimed at preventing C. difficile infection recurrences, and is also developing SER-155 to reduce infections in transplant patients.
Seres Therapeutics (MCRB) reported significant progress in its microbiome therapeutic SER-109, with confirmatory Phase 3 study results showing a sustained clinical response in 91.3% of recurrent C. difficile infection patients. The company initiated a rolling Biologics License Application (BLA) submission, expected to be completed soon. Financially, Seres strengthened its position with a $100 million equity offering, bringing its pro-forma cash balance to approximately $291.4 million. Despite a net loss of $64.7 million for Q2 2022, the company remains optimistic about SER-109's commercial potential.
Seres Therapeutics, Inc. (Nasdaq: MCRB) will host a conference call on August 3, 2022 at 8:30 a.m. ET to discuss its second quarter results and provide a business update.
Seres is noted for its SER-109 program, which has achieved significant clinical results in targeting C. difficile infections, receiving both Breakthrough Therapy and Orphan Drug designations from the FDA. The company is also advancing its SER-155 program to reduce infections in patients undergoing stem cell transplants.
Seres Therapeutics (MCRB) announced a registered direct offering of 31,746,030 shares at $3.15 per share, generating approximately $100 million in gross proceeds. The offering, which includes participation from notable investors like Federated Hermes and Nestlé Health Science, is expected to close on July 5, 2022. Proceeds will be used for the commercial readiness and manufacturing of SER-109 for the U.S. market and advancing its clinical development in the EU. The offering is conducted under a shelf registration statement filed with the SEC.
Seres Therapeutics (NASDAQ: MCRB) announced favorable results from the ECOSPOR IV study for SER-109, an oral microbiome therapy for recurrent C. difficile infection. The study showed a 91.3% sustained clinical response at eight weeks and confirmed a favorable safety profile, consistent with the previous ECOSPOR III study. A rolling Biologics License Application (BLA) submission has been initiated, with completion anticipated by mid-2022. The company aims for a potential launch in the first half of 2023, supported by FDA Breakthrough Therapy designation.
Seres Therapeutics, Inc. (MCRB) presented preclinical data highlighting the efficacy of the investigational microbial consortium DE486 in reducing chemotherapy-induced mucositis. The findings will be discussed at the 2022 ASCO Annual Meeting. Additionally, a Phase 1b trial of SER-155 is being conducted to assess its safety and efficacy in preventing complications during stem cell transplants. The company also plans to present Phase III results of SER-109 for recurrent C. difficile infection, which showed a lower recurrence rate than placebo. SER-109 is expected to submit a BLA to the FDA in mid-2022.
Seres Therapeutics, Inc. (Nasdaq: MCRB) presented promising data from its Phase 3 ECOSPOR III study, demonstrating that SER-109 effectively prevents recurrent C. difficile infections by establishing beneficial gut microbes. After one week of treatment, SER-109 increased microbiome diversity, producing fatty acids that inhibit C. difficile growth. The therapy showed an 88% success rate in preventing infection recurrence at eight weeks. Seres aims to submit a Biologics License Application by mid-2022, potentially leading to the first FDA-approved microbiome therapeutic by early 2023.
Seres Therapeutics (Nasdaq: MCRB) announced the presentation of its ECOSPOR III trial data for SER-109 at the Digestive Disease Week (DDW) Annual Meeting, scheduled for May 21-24, 2022. SER-109 is an investigational oral microbiome therapy aimed at preventing recurrent C. difficile infections. The company plans to submit a Biologics License Application (BLA) to the FDA in mid-2022. Presentations include an oral session on SER-109's impact on stool fatty acid metabolites and a poster on its durable engraftment. SER-109 has FDA Breakthrough and Orphan Drug designations.
Seres Therapeutics reported Q1 2022 results, highlighting significant progress with SER-109 for recurrent C. difficile infection (rCDI). The FDA approved a rolling submission for the Biologics License Application (BLA), targeting completion by mid-2022. SER-109 demonstrated superior efficacy with 88% of patients achieving sustained responses. The company faced a net loss of $56.6 million, an increase from $35.5 million the previous year, primarily driven by rising R&D costs. Seres ended the quarter with $248 million in cash, down from $291 million at the end of 2021, indicating potential cash burn risks.