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Seres Therapeutics, Inc. (Nasdaq: MCRB) is a pioneering clinical-stage biotherapeutic company focused on discovering and developing Ecobiotic™ therapeutic products. These novel drugs aim to treat significant diseases by targeting the underlying biology of the human microbiome. Founded by Flagship VentureLabs, Seres is at the forefront of creating the first therapeutics that induce a shift towards health by enhancing the microbiome's biology.
The company operates primarily in the United States, leveraging its microbiome therapeutics platform to develop Ecobiotic™ microbiome therapeutics. These therapies are designed to restore health by repairing the function of a dysbiotic microbiome, particularly in the colon. Seres' lead product, SER-109, is developed to prevent the recurrence of Clostridium difficile infection (CDI), a severe infection of the colon. Additional product candidates include SER-262, SER-287, and SER-401.
Recently, Seres announced the sale of its VOWST assets to Nestlé Health Science under a non-binding memorandum of understanding. This transaction will provide Seres with capital infusions, including an upfront payment, and is expected to be completed in the next 90 days, subject to shareholder approval and other conditions. VOWST, the first FDA-approved oral microbiome therapy, prevents the recurrence of CDI in adults following antibacterial treatment for recurrent CDI.
Seres plans to use the capital from this transaction to retire its existing debt and strengthen its financial position. The company is also advancing SER-155, evaluated in a Phase 1b study in patients undergoing allogeneic hematopoietic stem cell transplantation. SER-155 has the potential to reduce gastrointestinal and related bloodstream infections, as well as acute graft-versus-host disease.
Seres Therapeutics continues to innovate in microbiome therapeutics, aiming to benefit multiple underserved patient groups, including those with chronic liver disease, cancer neutropenia, and solid organ transplants. The company's approach could protect millions of medically vulnerable patients from life-threatening infections while addressing the global public health issue of antimicrobial resistance (AMR).
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.
Seres Therapeutics, Inc. (NASDAQ: MCRB) announced a conference call on May 4, 2022, at 8:30 a.m. ET to discuss its first quarter results and provide a business update. The call can be accessed by dialing 877-270-2148 (domestic) or 412-902-6510 (international). The company is known for its innovative microbiome therapeutics, particularly the SER-109 program, which has received Breakthrough Therapy and Orphan Drug designations from the FDA. SER-109 aims to reduce C. difficile infection recurrence, marking a significant milestone in microbiome-based treatments.
Seres Therapeutics (Nasdaq: MCRB) presents promising preclinical data on SER-155 at the European Bone Marrow Transplantation Annual Meeting. The findings indicate that SER-155 can potentially reduce infections and Graft-versus-Host Disease (GvHD) in patients undergoing hematopoietic stem cell transplantation. The ongoing Phase 1b clinical trial aims to evaluate SER-155's safety and efficacy after vancomycin treatment. Preliminary results show SER-155 enhances gut immunity and may restore a healthy microbiome, addressing a critical need in transplant recovery.
Seres Therapeutics (Nasdaq: MCRB) will present at the 32nd Annual Oppenheimer Healthcare Conference on March 17, 2022, at 8:00 a.m. ET, by CEO Eric Shaff. An audio webcast will be accessible via the Investors section of their website, with a replay available one hour post-event for 21 days. Seres is recognized for its SER-109 program, targeting recurrent C. difficile infections, which received Breakthrough Therapy and Orphan Drug designations from the FDA. The firm is also advancing SER-301 and SER-155 in clinical trials for ulcerative colitis and gastrointestinal infections respectively.
Seres Therapeutics (NASDAQ: MCRB) announced that CEO Eric Shaff will participate in a panel at the Cowen 42nd Annual Health Care Conference on March 9, 2022, at 10:30 a.m. ET. An audio webcast of the discussion will be available on their website, with a replay accessible for 21 days post-event.
Seres is recognized for its pioneering work in microbiome therapeutics, highlighted by its SER-109 program, which has achieved positive clinical results for treating C. difficile infections. Additionally, SER-301 and SER-155 are in Phase 1b studies targeting ulcerative colitis and infection prevention in medically compromised patients.
Seres Therapeutics (MCRB) announced its fourth quarter and full year 2021 financial results, reporting a net loss of $65.6 million for the year, improving from a loss of $89.1 million in 2020. Significant progress was noted in the Phase 3 ECOSPOR III study of SER-109 for recurrent C. difficile infection (rCDI), achieving its primary endpoint. A Biologics License Application (BLA) filing is anticipated in mid-2022, potentially making SER-109 the first microbiome therapeutic approved. The company also launched SER-155 for Infection Protection and reported cash reserves of approximately $291.2 million.
Seres Therapeutics, Inc. (Nasdaq: MCRB) will host a conference call on March 1, 2022, at 8:30 a.m. ET to discuss its Q4 2021 and full-year results, along with a general business update. Investors can join by calling 844-277-9450 for domestic or 336-525-7139 for international access, referencing conference ID 6277858. The event will also be available for live streaming on their website. Seres' SER-109 program achieved positive clinical results and has received FDA Breakthrough Therapy and Orphan Drug designations, targeting recurrent C. difficile infection.
Seres Therapeutics (Nasdaq: MCRB) announced that CEO Eric Shaff will present at the Chardan Metagenomics and Microbiome Medicines Summit on March 1, 2022, at 2:00 p.m. ET. An audio webcast of the presentation will be available on the company's website, with a replay accessible one hour post-event for 21 days. Seres is a pioneer in microbiome therapeutics, with its SER-109 program showing promising results for treating C. difficile infections. The company is also conducting Phase 1b studies for SER-301 and SER-155 targeting ulcerative colitis and infection prevention, respectively.
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