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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) has announced the enrollment of the first patient in its SER-155 Phase 1b clinical study, aimed at reducing infections, mortality, and graft-versus-host disease (GvHD) in patients undergoing hematopoietic stem cell transplantation (HSCT). SER-155, a microbiome therapeutic, targets antibiotic-resistant infections and aims to enhance microbiome diversity to improve patient outcomes. Collaborating with prestigious institutions like Memorial Sloan Kettering Cancer Center and The University of Chicago, the trial will assess both safety and effectiveness in approximately 70 patients.
Seres Therapeutics, Inc. (Nasdaq: MCRB) announced that President and CEO Eric Shaff will be participating in a pre-recorded fireside chat at the Piper Sandler 33rd Annual Virtual Healthcare Conference from November 29 to December 2, 2021. The chat will be available for on-demand viewing on the company’s website. Seres is at the forefront of microbiome therapeutics, with its SER-109 program achieving positive pivotal clinical results for treating recurrent C. difficile infection and receiving FDA Breakthrough Therapy designation. The company is also advancing additional programs for ulcerative colitis and gastrointestinal infections.
Seres Therapeutics (MCRB) announced completion of enrollment in its SER-109 recurrent C. difficile infection open-label study. The company anticipates filing a Biologics License Application (BLA) in mid-2022, pending Phase 3 results and safety data. Collaborations with Nestlé Health Science and Bacthera A.G. boost commercialization prospects for SER-109. Financially, Seres reported a net income of $68.2 million for Q3 2021, significant growth from a loss of $30.3 million in 2020. R&D expenses rose to $39.9 million, reflecting ongoing clinical development efforts.
Bacthera and Seres Therapeutics have announced a collaboration to manufacture SER-109, a lead product for recurrent Clostridioides difficile infection (rCDI). The partnership includes establishing a dedicated facility at Bacthera's new Microbiome Center of Excellence in Switzerland. This agreement aims to enhance commercial production capacity and support the manufacturing process, leveraging Bacthera's infrastructure while addressing the significant health threat posed by rCDI, responsible for high hospitalizations and deaths in the U.S.
Seres Therapeutics (Nasdaq: MCRB) will host a conference call and audio webcast on November 10, 2021, at 8:30 a.m. ET to discuss its third quarter 2021 results and provide a general business update. Interested parties can join via phone or the company's website. The firm is noted for its breakthrough microbiome therapeutics, particularly the SER-109 program, which has achieved positive clinical results for recurrent C. difficile infection. This program has received Breakthrough Therapy and Orphan Drug designations from the FDA.
Seres Therapeutics (Nasdaq: MCRB) announced promising results from its Phase 3 ECOSPOR III study of SER-109, an oral microbiome therapeutic aimed at reducing recurrent C. difficile infections (rCDI). The exploratory analysis revealed SER-109 significantly lowered rCDI risk in patients with pre-existing factors, such as those on acid-reducing medications. At 8 weeks, SER-109 showed an absolute recurrence reduction of 27% compared to placebo, translating to a 68% relative risk decrease. The study has potential implications for healthcare providers regarding treatment decisions for at-risk patients.
Seres Therapeutics (MCRB) announced significant findings from its Phase 3 ECOSPOR III study of SER-109, an oral microbiome therapy for recurrent C. difficile infection. The study demonstrated a substantial reduction in antimicrobial resistance genes (ARGs) in patients receiving SER-109 compared to placebo, with effects seen by Week 1 and lasting through Week 8. Results showed an 88% clinical response rate and a 27% reduction in recurrence rates at eight weeks. Seres plans to file a Biologics License Application with the FDA in mid-2022.
Seres Therapeutics (MCRB) announced the presentation of Phase 3 ECOSPOR III study data for SER-109 at IDWeek 2021, highlighting its significant impact on health-related quality of life and recurrence reduction for recurrent C. difficile infection (rCDI). SER-109 demonstrated improved health scores and reduced recurrence rates among patients with comorbidities. Additionally, SER-155 showed promise in decolonizing antibiotic-resistant pathogens. SER-109 has received Breakthrough Therapy and Orphan Drug designations from the FDA, enhancing its development prospects.
Seres Therapeutics (MCRB) has achieved enrollment of 300 subjects in the ECOSPOR IV study for SER-109, an oral microbiome therapy targeting recurrent C. difficile infection (rCDI). This milestone is crucial for the upcoming Biologics License Application (BLA) submission planned for mid-2022. SER-109 has shown a 30.2% reduction in rCDI recurrence and is positioned to be the first FDA-approved microbiome therapy. The deal with Nestlé Health Science includes a $175 million upfront payment and potential further milestones, highlighting a significant financial backing for Seres.
Seres Therapeutics, Inc. (Nasdaq: MCRB) announced participation in three investor conferences. Management will engage in a pre-recorded fireside chat at the H.C. Wainwright 23rd Annual Global Investment Conference on September 13, 2021. Additionally, a fireside chat is scheduled for September 15, 2021, at the Morgan Stanley 19th Annual Global Healthcare Conference. Lastly, Seres will hold investor meetings during the Oppenheimer Fall Healthcare Life Sciences & Med Tech Summit on September 22, 2021. Webcast replays will be available on their website post-event.