Firmicutes

Seres Therapeutics to Host Investor Webcast on December 8, 2022 to Discuss SER-109 Commercial Strategy

Retrieved on: 
Tuesday, November 22, 2022
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Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced that it will host an investor webcast to discuss the planned commercialization approach and market opportunity for therapeutic candidate SER-109 in recurrent C. difficile infection (rCDI) on Thursday, December 8, 2022, at 8:30 a.m.

Key Points: 
  • Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced that it will host an investor webcast to discuss the planned commercialization approach and market opportunity for therapeutic candidate SER-109 in recurrent C. difficile infection (rCDI) on Thursday, December 8, 2022, at 8:30 a.m.
  • The SER-109 investor webcast will include members of management from Seres Therapeutics, Aimmune Therapeutics, Inc., a Nestl Health Science Company, as well as Carl Crawford M.D.
  • To join the live webcast, please visit the Investors and News section of the Seres website at www.serestherapeutics.com .
  • Seres Therapeutics, Inc. (Nasdaq: MCRB) is a leading microbiome therapeutics company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease.

Acurx Pharmaceuticals, Inc. to Discuss 2022 Third Quarter Financial Results on November 14, 2022 Conference Call and Provide Business Update

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Tuesday, November 1, 2022
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It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections.

Key Points: 
  • It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections.
  • The Company successfully completed Phase 1 and Phase 2a clinical trials of ibezapolstat.
  • The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.
  • Acurx Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing new antibiotics for difficult to treat infections.

Seres Therapeutics Announces FDA Acceptance of Biologics License Application for Investigational Microbiome Therapeutic SER-109 for Recurrent C. Difficile Infection for Priority Review

Retrieved on: 
Wednesday, October 26, 2022
FDA, Health, Science, Research, Clinical Trials, U.S. Securities and Exchange Commission, CDC, PDUFA, Therapy, Risk, SEC, Growth, Review, Bloodstream infections, The New England Journal of Medicine, Variometer, Breakthrough therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CDI, Patient, Prescription Drug User Fee Act, Research, Tissue, Advisory Committee, Security (finance), Hospital-acquired infection, Nasdaq, Orphan drug, Private Securities Litigation Reform Act, Food, Center, Company, Firmicutes, Perseverance, Graft-versus-host disease, David Berry (inventor), Spore, BLA, Adult, Hematopoietic stem cell transplantation, Recurrence, Korea Disease Control and Prevention Agency, Ulcerative colitis, Priority review, FDA, COVID-19, Biologics license application, Pharmaceutical industry, Serica

Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for investigational oral microbiome therapeutic SER-109 for the prevention of recurrent C. difficile infection (rCDI).

Key Points: 
  • Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for investigational oral microbiome therapeutic SER-109 for the prevention of recurrent C. difficile infection (rCDI).
  • The application has been granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) action date of April 26, 2023.
  • The FDA advised that they are not currently planning to hold an Advisory Committee Meeting to discuss the SER-109 application.
  • Seres has received an upfront license payment of $175 million and will receive an additional $125 million upon FDA approval of SER-109.

Seres Therapeutics’ ECOSPOR III Study Data on SER-109 Published in Journal of the American Medical Association

Retrieved on: 
Wednesday, October 19, 2022
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We are honored to see these important findings published in such a well-regarded medical research journal, said Lisa von Moltke, M.D., Chief Medical Officer at Seres and publication co-author.

Key Points: 
  • We are honored to see these important findings published in such a well-regarded medical research journal, said Lisa von Moltke, M.D., Chief Medical Officer at Seres and publication co-author.
  • The JAMA paper summarizes data from the secondary endpoints of the multicenter, double-blind ECOSPOR III trial ( NCT03183128 ), which enrolled 182 participants with a history of rCDI and randomly assigned them to receive either SER-109 or placebo.
  • While comorbidities were common among study participants in both arms of the study, SER-109 was well-tolerated with no serious treatment-related adverse events observed over the course of the 24-week study period.
  • These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Seres Therapeutics to Present Clinical Results at IDWeek and American College of Gastroenterology (ACG) 2022 Annual Meeting

Retrieved on: 
Wednesday, October 12, 2022
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SER-109 is an entirely new treatment modality that shows promise to improve the current standard of care for rCDI.

Key Points: 
  • SER-109 is an entirely new treatment modality that shows promise to improve the current standard of care for rCDI.
  • SER-109 is an oral microbiome therapeutic candidate consisting of a consortium of highly purified Firmicutes spores, which normally live in a healthy microbiome.
  • Seres SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA.
  • These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Seres Therapeutics Announces Completion of Rolling BLA Submission to FDA for Investigational Microbiome Therapeutic SER-109 for Recurrent C. Difficile Infection

Retrieved on: 
Wednesday, September 7, 2022
FDA, Health, Research, Pharmaceutical, Science, Biotechnology, Patient, COVID-19, Security (finance), BLA, Hematopoietic stem cell transplantation, Research, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Therapy, Recurrence, Tissue, Spore, CDI, Variometer, Food, SEC, David Berry (inventor), Bloodstream infections, Infection, U.S. Securities and Exchange Commission, Leadership, Nasdaq, Breakthrough therapy, FDA, Company, Orphan drug, The New England Journal of Medicine, Risk, Private Securities Litigation Reform Act, Growth, Firmicutes, Ulcerative colitis, Review, Graft-versus-host disease, Pharmaceutical industry, MD, Serica

SER-109 has FDA Breakthrough Therapy designation, which provides the potential for priority review of the BLA.

Key Points: 
  • SER-109 has FDA Breakthrough Therapy designation, which provides the potential for priority review of the BLA.
  • If granted, Seres anticipates the potential approval and launch of SER-109 in the first half of 2023, with SER-109 potentially becoming the first ever FDA-approved oral microbiome therapeutic.
  • After well over a decade of research, Seres has established strong leadership in the development of microbiome therapeutics with a promising pipeline, said Eric Shaff, President and Chief Executive Officer at Seres.
  • The SER-109 program is being advanced to prevent further recurrences of C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic.

Acurx Pharmaceuticals, Inc. to Discuss 2022 Second Quarter Financial Results on August 16, 2022 Conference Call and Provide Business Update

Retrieved on: 
Thursday, August 4, 2022
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It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections.

Key Points: 
  • It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections.
  • The Company successfully completed Phase 1 and Phase 2a clinical trials of ibezapolstat.
  • Acurx is currently enrolling patients in its Phase 2b vancomycin-controlled efficacy study in a 1:1 randomized trial of a total of 64 patients with CDI.
  • Acurx Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing new antibiotics for difficult to treat infections.

Seres Therapeutics Announces Confirmatory Results from Investigational Microbiome Therapeutic SER-109 ECOSPOR IV Open-Label Study in Recurrent C. Difficile Infection

Retrieved on: 
Tuesday, June 7, 2022
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Seres Therapeutics, Inc. (Nasdaq: MCRB) today announced confirmatory results from ECOSPOR IV, an open-label study for SER-109, an investigational oral microbiome therapeutic for the prevention of recurrent C. difficile infection (rCDI).

Key Points: 
  • Seres Therapeutics, Inc. (Nasdaq: MCRB) today announced confirmatory results from ECOSPOR IV, an open-label study for SER-109, an investigational oral microbiome therapeutic for the prevention of recurrent C. difficile infection (rCDI).
  • The ECOSPOR IV data confirm the well-tolerated safety profile and clinical benefit observed in the prior ECOSPOR III study, said Eric Shaff, President and Chief Executive Officer at Seres.
  • These results, along with the start of the rolling BLA submission, significantly advance our ability to deliver what may be the first FDA-approved microbiome therapeutic.
  • Safety data across both ECOSPOR IV and ECOSPOR III are expected to fulfill this requirement and complete Seres Phase 3 program for SER-109.

Seres Therapeutics Presents Phase Ill Results of SER-109 for Recurrent C. Difficile Infection at the Digestive Disease Week (DDW) Annual Meeting

Retrieved on: 
Sunday, May 22, 2022
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These data were shared in oral and poster presentations at the 2022 Digestive Disease Week (DDW) Annual Meeting.

Key Points: 
  • These data were shared in oral and poster presentations at the 2022 Digestive Disease Week (DDW) Annual Meeting.
  • The pattern of results was the same regardless of which antibiotic participants received, vancomycin or fidaxomicin.
  • The SER-109 program is being advanced to prevent the recurrence of C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic.
  • These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Seres Therapeutics to Present Data on Investigational Microbiome Therapeutic SER-109 for Recurrent C. Difficile Infection at the Digestive Disease Week (DDW) Annual Meeting

Retrieved on: 
Tuesday, May 10, 2022
Research, Infectious Diseases, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, COVID-19, Treatment, U.S. Securities and Exchange Commission, Graft-versus-host disease, Private Securities Litigation Reform Act, Clostridioides difficile infection, Ulcerative colitis, Nasdaq, Gastrointestinal disease, User experience, Company, Food, Physician, Safety, Hematopoietic stem cell transplantation, Patient, BLA, Security (finance), Recurrence, FDA, DDW, Variometer, National Digestive Diseases Information Clearinghouse, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CDI, Firmicutes, Orphan drug, Tissue, Breakthrough therapy, Biologics license application, David Berry (inventor), Bloodstream infections, SEC, Spore, Research, Growth, Annual general meeting, Risk, Pharmaceutical industry, Serica

Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced that it will present data from its ECOSPOR III trial of SER-109 at the Digestive Disease Week (DDW) Annual Meeting, which is taking place May 21-24, 2022.

Key Points: 
  • Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced that it will present data from its ECOSPOR III trial of SER-109 at the Digestive Disease Week (DDW) Annual Meeting, which is taking place May 21-24, 2022.
  • SER-109 is an investigational oral microbiome therapeutic for the prevention of recurrent C. difficile infection (rCDI).
  • With an oral and poster presentation, Seres will present data on how SER-109 restores the functionality of the microbiome in a rapid and durable manner, which further supports the potential of microbiome therapeutics.
  • Seres expects to finalize a Biologics License Application (BLA) submission for SER-109 with the U.S. Food and Drug Administration (FDA) in mid-2022.