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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 (NASDAQ: MCRB) has commenced enrollment for Cohort 2 of its Phase 1b study of SER-155, an oral microbiome therapeutic aimed at reducing gastrointestinal infections and graft versus host disease in patients undergoing allogeneic hematopoietic stem cell transplantation. Following a positive review from the Data and Safety Monitoring Board, the company plans to report initial safety and pharmacological data from Cohort 1 in the upcoming months. SER-155's development is based on promising results from the Phase 3 SER-109 program. The company estimates over 9,000 patients receive allo-HSCT annually in the U.S., with significant associated management costs.
Seres Therapeutics, Inc. (Nasdaq: MCRB) announced on
Seres Therapeutics (NASDAQ: MCRB) announced on January 11, 2023, that its Compensation and Talent Committee granted equity awards to five new employees. This consists of 9,000 stock options at an exercise price of $5.26 per share and 4,500 restricted stock units (RSUs). The awards are governed by the Seres 2022 Employment Inducement Award Plan, which was established in December 2022 to attract new talent. Stock options vest over time, starting with 25% after one year of employment. Seres continues to develop innovative microbiome therapeutics aimed at treating diseases through functional interaction with host cells and tissues.
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.
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