Seres Therapeutics, Inc. - MCRB STOCK NEWS

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.

Seres Therapeutics (MCRB) announced positive Phase 3 clinical results for SER-109, an oral microbiome therapeutic, published in JAMA. The study indicates that SER-109 significantly reduces the risk of recurrent C. difficile infection (rCDI) within 24 weeks post-treatment. With approximately 170,000 annual rCDI cases in the U.S., SER-109 aims to enhance the standard of care. The FDA has granted Breakthrough Therapy and Orphan Drug designations for SER-109, and a Biologics License Application has been submitted, with expectations for approval in early 2023.

Seres Therapeutics (Nasdaq: MCRB) announced the presentation of Phase III ECOSPOR IV trial data for its oral microbiome therapeutic SER-109, aimed at preventing recurrent C. difficile infection. This significant data will be showcased at IDWeek 2022 and the ACG 2022 Annual Meeting. SER-109 has received Breakthrough Therapy and Orphan Drug designations from the FDA, indicating its potential to improve treatment standards. The urgent need for effective solutions is underscored by CDC data showing nearly 170,000 annual C. difficile cases in the U.S.

Seres Therapeutics (NASDAQ: MCRB) presented at the World Anti-Microbial Resistance Congress on September 7-8, 2022, discussing advancements in microbiome therapeutics to combat antibiotic-resistant bacterial infections. Chief Scientific Officer Dr. Matthew Henn highlighted Phase 3 data showing that SER-109 reduced antibiotic-resistant pathogens. The company also focuses on SER-155, targeting patients undergoing stem cell transplantation. SER-109's Biologics License Application has been filed with the FDA, with a commercial launch expected in early 2023.

Seres Therapeutics (Nasdaq: MCRB) has completed its rolling submission for a Biologics License Application (BLA) to the FDA for SER-109, targeting recurrent C. difficile infections. With FDA Breakthrough Therapy designation, SER-109 could launch in the first half of 2023, aiming to be the first FDA-approved oral microbiome therapeutic. The submission is based on promising Phase 3 trial results showing an 88% sustained response rate compared to 60% for placebo. Seres has partnered with Aimmune Therapeutics for commercialization, receiving an upfront payment of $175 million.

Seres Therapeutics, Inc. (Nasdaq: MCRB), a leader in microbiome therapeutics, announced that CEO Eric Shaff will participate in the Canaccord Genuity 42nd Annual Growth Conference on August 10 at 12:30 p.m. ET. An audio webcast of the event will be accessible on the company's website, with a replay available for 21 days.

Seres is known for its SER-109 program, the first microbiome drug candidate to achieve positive pivotal clinical results, aimed at preventing C. difficile infection recurrences, and is also developing SER-155 to reduce infections in transplant patients.

Seres Therapeutics (MCRB) reported significant progress in its microbiome therapeutic SER-109, with confirmatory Phase 3 study results showing a sustained clinical response in 91.3% of recurrent C. difficile infection patients. The company initiated a rolling Biologics License Application (BLA) submission, expected to be completed soon. Financially, Seres strengthened its position with a $100 million equity offering, bringing its pro-forma cash balance to approximately $291.4 million. Despite a net loss of $64.7 million for Q2 2022, the company remains optimistic about SER-109's commercial potential.

Seres Therapeutics, Inc. (Nasdaq: MCRB) will host a conference call on August 3, 2022 at 8:30 a.m. ET to discuss its second quarter results and provide a business update.

Seres is noted for its SER-109 program, which has achieved significant clinical results in targeting C. difficile infections, receiving both Breakthrough Therapy and Orphan Drug designations from the FDA. The company is also advancing its SER-155 program to reduce infections in patients undergoing stem cell transplants.