Seres Therapeutics, Inc. - MCRB STOCK NEWS

Seres Therapeutics, Inc. (Nasdaq: MCRB) held a conference call to discuss topline results from the Phase 2b ECO-RESET study evaluating SER-287 for mild-to-moderate ulcerative colitis. The company has also advanced SER-109 for recurrent C. difficile infection, achieving positive pivotal clinical results and receiving Breakthrough Therapy and Orphan Drug designations from the FDA. Current evaluations include SER-301 and SER-155 in ongoing Phase 1b studies. The press release includes forward-looking statements highlighting potential challenges in profitability and clinical development.

Seres Therapeutics (MCRB) announced topline results from its Phase 2b ECO-RESET study of SER-287 for mild-to-moderate ulcerative colitis. The study failed to meet its primary endpoint for improving clinical remission rates compared to placebo, with remission rates of 10.3% and 10.6% for full and step-down doses respectively, against 11.6% for placebo. Adverse events were reported in 67.6% of subjects in the active treatment arms. Following these results, the company will close the open label portions of the study and focus on advancing SER-109, SER-301, and their early-stage pipeline.

Seres Therapeutics, Inc. (Nasdaq: MCRB) has partnered with Nestlé Health Science to co-commercialize SER-109, a microbiome therapy targeting recurrent Clostridioides difficile infection, in the U.S. and Canada. Seres will receive $175 million upfront and $125 million upon FDA approval, plus up to $225 million in sales milestones. Upon commercialization, Seres will earn 50% of profits. SER-109 aims to be the first FDA-approved microbiome therapy, with promising clinical results indicating a 27% absolute reduction in CDI recurrence. A Joint Steering Committee will oversee collaboration activities.

Seres Therapeutics (Nasdaq: MCRB) will host a virtual investor event on June 21, 2021, from 8:30 a.m. to 10:00 a.m. ET, to discuss its investigational therapies SER-287 and SER-301 for ulcerative colitis (UC). Management and Dr. Stephen Hanauer will highlight the UC patient burden and the need for new treatments. SER-287 is in a Phase 2b trial for active mild-to-moderate UC, with data expected mid-2021. SER-301 is under evaluation in a Phase 1b study. Interested participants can join via the company's website or conference call.

Seres Therapeutics, Inc. (Nasdaq: MCRB), a microbiome therapeutics leader, announced that its Chief Commercial and Strategy Officer, Terri Young, Ph.D., will present at the JMP Securities Life Sciences Conference on June 17, 2021, at 1:00 p.m. ET. The presentation will be accessible via an audio webcast on Seres’ website and will be archived for 21 days post-event. Seres is developing a novel class of multifunctional bacterial therapies, with its SER-109 program targeting recurrent C. difficile infection and SER-287 aimed at pediatric ulcerative colitis.

Seres Therapeutics, Inc. (Nasdaq: MCRB) announced that the FDA has approved the IND application for SER-155, an investigational microbiome therapeutic aimed at reducing gastrointestinal infections in immunocompromised patients. The Phase 1b study will include around 70 patients to assess the safety and efficacy of SER-155 in preventing infections and graft-versus-host disease (GvHD) post-allogeneic hematopoietic stem cell transplantation (HSCT). SER-155 has potential to significantly impact treatment outcomes for patients facing serious antibiotic-resistant infections.

Seres Therapeutics, Inc. (Nasdaq: MCRB) announced participation in two upcoming investor conferences: the Jefferies Virtual Healthcare Conference on June 1, 2021, at 2:30 p.m. ET and the Goldman Sachs 42nd Annual Global Healthcare Conference on June 8, 2021, at 11:20 a.m. ET. An audio webcast of both presentations will be available on Seres’ website for 21 days post-event. Seres specializes in microbiome therapeutics, with notable programs like SER-109 for recurrent C. difficile infections, awarded Breakthrough Therapy designation by the FDA.

Seres Therapeutics (Nasdaq: MCRB) announced compelling results from the Phase 3 ECOSPOR III study of SER-109, a microbiome therapy for recurrent C. difficile infection (rCDI). The final 24-week data revealed a recurrence rate of 21.3% for SER-109 compared to 47.3% for placebo, showcasing a 54% relative risk reduction (p < 0.001). The safety profile was comparable to placebo, reinforcing SER-109's potential as a first-in-class treatment. Clinical data will be presented during Digestive Disease Week 2021, alongside advancements in SER-287 and SER-301 for ulcerative colitis.

Seres Therapeutics, Inc. (Nasdaq: MCRB) has appointed David Arkowitz as the new Executive Vice President and Chief Financial Officer, effective June 1, 2021. Arkowitz brings over 30 years of experience in finance and operations from notable companies in the biotech sector, enhancing Seres' leadership team amid its pivotal SER-109 program approaching BLA submission. The company is focused on developing microbiome therapeutics, with SER-109 showing promise for recurrent C. difficile infection. The firm has received Breakthrough Therapy and Orphan Drug designations from the FDA.