News & Events
Seres Therapeutics Announces FDA Acceptance of Biologics License Application for Investigational Microbiome Therapeutic SER-109 for Recurrent C. Difficile Infection for Priority Review (opens in a new tab)
– If approved, SER-109 expected to be the first-ever FDA-approved oral microbiome therapeutic – – PDUFA target action date is April 26, 2023 , with anticipated launch soon thereafter – – FDA advised that they are not currently planning to hold an Advisory Committee Meeting to discuss the SER-109…
Seres Therapeutics Presents SER-109 ECOSPOR IV Study Data at IDWeek and American College of Gastroenterology (ACG) 2022 Annual Meetings (opens in a new tab)
– Investigational oral microbiome therapeutic was observed to reduce recurrent C. difficile infection (rCDI) after just one recurrence and remained low regardless of diagnostic approach – – Clinical data shows SER-109 is well tolerated, including among people with multiple comorbidities –…
Seres Therapeutics’ ECOSPOR III Study Data on SER-109 Published in Journal of the American Medical Association (opens in a new tab)
– Summarized data from the study’s secondary endpoints show investigational oral microbiome therapeutic rapidly and durably lowered risk of recurrent C. difficile infection – CAMBRIDGE, Mass. –(BUSINESS WIRE)–Oct. 19, 2022– Seres Therapeutics, Inc.…
Seres Therapeutics to Present Clinical Results at IDWeek and American College of Gastroenterology (ACG) 2022 Annual Meeting (opens in a new tab)
– Company to present Phase III ECOSPOR IV data evaluating safety, efficacy and durability of investigational oral microbiome therapeutic SER-109 for the prevention of recurrent C. difficile infection – CAMBRIDGE, Mass. –(BUSINESS WIRE)–Oct. 12, 2022– Seres Therapeutics, Inc.…
Ferring Receives Positive Vote from U.S. FDA Advisory Committee for RBX2660 (opens in a new tab)
Vaccines and Related Biological Products Advisory Committee reviewed data from the biologics license application for RBX2660 RBX2660 is an investigational microbiota-based live biotherapeutic studied for its potential to reduce recurrence of C. difficile infection after antibiotic treatment Recurrent C. difficile infec…
Seres Therapeutics to Present at World Anti-Microbial Resistance Congress (opens in a new tab)
– Clinical and preclinical data support Seres’ development of microbiome therapeutics to reduce the incidence of antibiotic-resistant bacterial infections – CAMBRIDGE, Mass. –(BUSINESS WIRE)–Sep. 8, 2022– Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today…
Seres Therapeutics Announces Completion of Rolling BLA Submission to FDA for Investigational Microbiome Therapeutic SER-109 for Recurrent C. Difficile Infection (opens in a new tab)
– Investigational therapeutic SER-109 has the potential to become the first-ever FDA-approved oral microbiome therapeutic – – Anticipated product launch in the first half of 2023 – CAMBRIDGE, Mass. –(BUSINESS WIRE)–Sep. 7, 2022– Seres Therapeutics, Inc.…
Genetic Analysis appoints Sedermera Corporate Finance AB to act as a liquidity provider for the Company´s share (opens in a new tab)
The post Genetic Analysis appoints Sedermera Corporate Finance AB to act as a liquidity provider for the Company´s share appeared first on Genetic Analysis.…
CORRECTION: Interim report January – June 2022 (opens in a new tab)
Correction: Correction of the previously disclosed press release since the headline stated January – March. The correct timeline for the interim report is January – June. Otherwise, there are no changes from the previously published press release. Oslo, Norway, August 18, 2022 – Genetic Analysis AS (“GA” or “the Compan…
Interim report January – June 2022 (opens in a new tab)
The post Interim report January – June 2022 appeared first on Genetic Analysis.…
Seres Therapeutics to Present at Canaccord Genuity 42nd Annual Growth Conference (opens in a new tab)
CAMBRIDGE, Mass. –(BUSINESS WIRE)–Aug. 4, 2022– Seres Therapeutics, Inc . (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced that Eric Shaff , President and Chief Executive Officer, will participate in a discussion at the Canaccord Genuity 42nd Annual Growth Conference on…
Seres Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Updates (opens in a new tab)
– Expect to complete SER-109 Biologics License Application filing in the coming weeks – – Reported confirmatory SER-109 Phase 3 study results, including in individuals with a first recurrence of C. difficile infection – – Strengthened balance sheet with $100 million registered direct equity…
Seres Therapeutics to Host Second Quarter 2022 Financial Results and Operational Progress Conference Call and Webcast on August 3, 2022 (opens in a new tab)
CAMBRIDGE, Mass. –(BUSINESS WIRE)–Jul. 28, 2022– Seres Therapeutics, Inc . (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced that management will host a conference call and live audio webcast on August 3, 2022 , at 8:30 a.m.…
Seres Therapeutics Announces $100 Million Registered Direct Offering of Common Stock (opens in a new tab)
CAMBRIDGE, Mass. –(BUSINESS WIRE)–Jun. 30, 2022– Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced that it has entered into securities purchase agreements with new and existing investors and certain directors and officers in a registered direct…
Vedanta Unveils State-of-the-Art Manufacturing Facility to Provide Clinical and Commercial Supply of Oral Therapies Based on Defined Bacterial Consortia (opens in a new tab)
Multi-product CGMP facility designed to meet global regulatory standards for the manufacture of oral therapies based on defined bacterial consortia Facility will supply planned Phase 3 clinical trial and potential commercial launch of VE303 in Clostridioides difficile infection CAMBRIDGE, MA – Vedanta Biosciences, a cl…
Genetic Analysis and Servatus enter Strategic Collaboration Agreement to develop new microbiome diagnostic and therapeutic solutions (opens in a new tab)
The post Genetic Analysis and Servatus enter Strategic Collaboration Agreement to develop new microbiome diagnostic and therapeutic solutions appeared first on Genetic Analysis.…
Norne Securities initiates coverage of Genetic Analysis (opens in a new tab)
OSLO, NORWAY – June 16, 2022: Norne Securities (“Norne”) initiates coverage of Genetic Analysis (“GA”), a pioneering human microbiome field company based in Oslo. The report can be read at www.genetic-analysis.com/analyst-coverage/.…
Vedanta Biosciences to Participate in the JMP Securities Life Sciences Conference (opens in a new tab)
CAMBRIDGE, MA, June 8, 2022 – Vedanta Biosciences, a clinical-stage company that is developing a potential new category of oral therapies based on defined bacterial consortia, today announced that Bernat Olle, Ph.D., Chief Executive Officer of Vedanta Biosciences, will participate in a fireside chat at the JMP Securiti…
Microba and Ginkgo commence therapeutics program (opens in a new tab)
Microba’s Autoimmune Disease program has officially commenced, with the first strains from Microba’s biobank supplied to development partner Ginkgo Bioworks. The post Microba and Ginkgo commence therapeutics program appeared first on Microba Life Sciences.…
Seres Therapeutics Announces Confirmatory Results from Investigational Microbiome Therapeutic SER-109 ECOSPOR IV Open-Label Study in Recurrent C. Difficile Infection (opens in a new tab)
– ECOSPOR IV study shows favorable safety profile through 24-week follow-up, consistent with the safety profile observed in ECOSPOR III study – 91.3% sustained clinical response achieved at eight weeks in overall population with consistent results in key subpopulations including first recurrence –…