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Seres Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Updates

Retrieved on: 
Tuesday, March 5, 2024
Biotechnology, Infectious Diseases, Health, Pharmaceutical, Clinical Trials, Fast Track, Therapy, HCP, Chronic liver disease, David Berry (inventor), Recurrence, Clostridioides difficile infection, Infection, Research, Fast track (FDA), Education, FDA, Term loan, Variometer, Growth, Use, Retirement, ID, Sale, CDI, Immunodeficiency, Oaktree Capital Management, Risk, Commercial, Graft-versus-host disease, Intensive care medicine, Medicare, Spore, Patient, Medicare Part D, Acceleration, Gastroenterology, Clostridioides, Limitation, AMR, Pharmaceutical industry

Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today reported fourth quarter and full year 2023 financial results and provided business updates.

Key Points: 
  • Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today reported fourth quarter and full year 2023 financial results and provided business updates.
  • From launch through year-end 2023, there were 2,833 completed prescription enrollment forms received for VOWST, of those 2,015 resulted in new patient starts by year-end 2023.
  • Strong adoption of VOWST since commercial launch in June 2023 with broad utilization, continued quarter over quarter growth, and significant progress achieving patient access.
  • General and administrative expenses for the fourth quarter of 2023 were $17.2 million, compared with $22.4 million for the same period in 2022.

Seres Therapeutics Announces VOWST™ Commercial Launch Update and US FDA Fast Track Designation for SER-155

Retrieved on: 
Tuesday, January 9, 2024
FDA, Infectious Diseases, Health, Stem Cells, Clinical Trials, Clostridioides difficile infection, Graft-versus-host disease, Patient, Therapy, Incidence, Growth, Oaktree Capital Management, Medicare, Spore, Commercial, HCP, Clostridioides, Risk, Recurrence, Variometer, Immunodeficiency, Investment, CDI, Conference, Drug development, Medicare Part D, Fast track (FDA), Term loan, David Berry (inventor), Infection, Education, Pharmaceutical industry

“In 2023, VOWST received FDA approval with a broad indication, which includes use in first recurrence patients.

Key Points: 
  • “In 2023, VOWST received FDA approval with a broad indication, which includes use in first recurrence patients.
  • The SER-155 Cohort-2 readout is expected in the third quarter, and we are excited to announce receipt of Fast Track Designation for SER-155 to reduce the risk of infection and GvHD in allo-HSCT patients.
  • Production of VOWST commercial supply enabled a strong commercial launch within weeks of approval; progress in expansion of VOWST manufacturing capacity.
  • To report SUSPECTED ADVERSE REACTIONS, contact Aimmune Therapeutics at 1-833-AIM-2KNO (1-833-246-2566), or the FDA at 1-800-FDA-1088, or visit www.fda.gov/MedWatch .

Seres Therapeutics Reports Third Quarter 2023 Financial Results Including VOWST™ Net Sales of $7.6 Million

Retrieved on: 
Thursday, November 2, 2023
Biotechnology, General Health, Other Health, Health, Genetics, Gastroenterology, FDA, Research, Sale, Clostridioides, Clostridioides difficile infection, David Berry (inventor), CDI, Therapy, Nestlé, Workforce, Infection, Oak Tree, Growth, Oaktree Capital Management, Disease, Medicine, Risk, Recurrence, Term loan, Investment, Patient, Variometer, Pharmaceutical industry, Antibiotics, Nursing, Collaboration

Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today reported financial results for the third quarter ended September 30, 2023, including VOWST net sales of $7.6 million.

Key Points: 
  • Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today reported financial results for the third quarter ended September 30, 2023, including VOWST net sales of $7.6 million.
  • Seres anticipates incurring a one-time charge of $5.0-$5.5 million in the fourth quarter of 2023, primarily related to the workforce reduction.
  • Seres reported a net loss of $47.9 million for the third quarter of 2023, as compared with a net loss of $60.0 million for the same period in 2022.
  • Net sales of VOWST for the third quarter of 2023, the first full quarter following launch, were $7.6 million based on 506 units.

 Seres Therapeutics to Highlight VOWST™ Data at IDWeek

Retrieved on: 
Thursday, October 12, 2023
Biotechnology, General Health, Pharmaceutical, Health, Food, Abstract, Medical diagnosis, CDI, Risk, Clostridioides difficile infection, US Foods, FDA, Therapy, Doctor of Philosophy, Variometer, Post hoc, Recurrence, Infection, David Berry (inventor), Patient, Pharmaceutical industry, Communications satellite

“The data we are presenting this year at IDWeek build upon our earlier findings that the gastrointestinal microbiome is similarly disrupted in patients with first or multiple rCDI.

Key Points: 
  • “The data we are presenting this year at IDWeek build upon our earlier findings that the gastrointestinal microbiome is similarly disrupted in patients with first or multiple rCDI.
  • The introduction of VOWST has provided a means to alleviate suffering and health risks associated with recurrent instances of this serious disease," said Matthew Henn, Ph.D., Chief Scientific Officer at Seres.
  • Report any infection that is suspected to have been transmitted by VOWST to Aimmune Therapeutics, Inc. at 1-833-246-2566.
  • To report SUSPECTED ADVERSE REACTIONS, contact Aimmune Therapeutics at 1-833-AIM-2KNO (1-833-246-2566), or the FDA at 1-800-FDA-1088, or visit www.fda.gov/MedWatch .

PureTech Health plc – Half-Year Report

Retrieved on: 
Tuesday, August 29, 2023
Infectious Diseases, Neurology, Clinical Trials, Stem Cells, Cardiology, Biotechnology, Health, Pharmaceutical, Oncology, Clostridioides difficile infection, Plan, Central nervous system, Depression, Psychosis, University, Fragile X-associated tremor/ataxia syndrome, U.S. Department of Defense Strategy for Operating in Cyberspace, Gel, Engineering, Classification, Schizophrenia, Food allergy, Anxiety, ADHD, University of California, Davis, PureTech Health, Fast Track, Attention, CNS, Attention deficit hyperactivity disorder predominantly inattentive, AML, Investigational New Drug, Patient, Investment, KRTX, Variometer, Ageing, KarXT, FDA, IPF, Safety, Vaccine, Pharmaceutical industry, Dietary supplement, Cryptocurrency, Vedanta, Gelesis, Yolo Akili, FXTAS

Awarded up to $11.4 million from the U.S. Department of Defense to advance LYT-300 for Fragile X-associated Tremor/ Ataxia Syndrome (FXTAS).

Key Points: 
  • Awarded up to $11.4 million from the U.S. Department of Defense to advance LYT-300 for Fragile X-associated Tremor/ Ataxia Syndrome (FXTAS).
  • Akili subsequently released EndeavorOTC,10 a video game treatment to improve attention in adults 18 years and older with ADHD, available without a prescription.
  • Gelesis and PureTech have entered into an Agreement and Plan of Merger, subject to agreed upon terms and conditions.
  • PureTech has also entered into an Agreement and Plan of Merger to purchase all of the outstanding stock of Gelesis and take the company private.

Amber Specialty Pharmacy Selected to Dispense VOWST™ Capsules for the Prevention of Recurrence of C. Difficile Infection in Adults

Retrieved on: 
Thursday, July 13, 2023
Retail, Health, Supermarket, Specialty, General Health, Pharmaceutical, Clostridioides difficile infection, CDI, Pharmacy, Education, Clostridioides, Person, URAC, Accreditation Commission for Health Care, Specialty pharmacy, Patient, Variometer, ACHC, National Association, Recurrence, Hospital, Nursing

Amber Specialty Pharmacy will begin dispensing VOWST, which is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI).

Key Points: 
  • Amber Specialty Pharmacy will begin dispensing VOWST, which is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI).
  • “When caring for patients with rCDI, immediate treatment is critical,” said Kristin Williams, president of Amber Specialty Pharmacy.
  • Amber Specialty Pharmacy is accredited by the Utilization Review Accreditation Commission (URAC) and the Accreditation Commission for Health Care (ACHC).
  • Amber Specialty Pharmacy was named the 2020 Specialty Pharmacy of the Year by the National Association of Specialty Pharmacy.

Orsini Specialty Pharmacy Now Dispensing VOWST™ (fecal microbiota spores, live - brpk) Capsules for Oral Administration for the Prevention of Recurrence of C. Difficile Infection in Adults Following Antibacterial Treatment for Recurrent CDI

Retrieved on: 
Thursday, June 22, 2023
Variometer, Clostridioides difficile infection, CDI, ELK, Therapy, Recurrence, Patient, Spore, Clostridioides, West Midlands CARE Team, Pharmaceutical industry, Hospital

ELK GROVE VILLAGE, Ill., June 22, 2023 /PRNewswire/ -- Orsini Specialty Pharmacy announced today that Aimmune Therapeutics has selected it as a limited distribution partner for VOWST™ (fecal microbiota spores, live – brpk).

Key Points: 
  • ELK GROVE VILLAGE, Ill., June 22, 2023 /PRNewswire/ -- Orsini Specialty Pharmacy announced today that Aimmune Therapeutics has selected it as a limited distribution partner for VOWST™ (fecal microbiota spores, live – brpk).
  • VOWST is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI).
  • Limitation of Use: VOWST is not indicated for the treatment of CDI.
  • "Orsini Specialty Pharmacy's dedicated Care Team will ensure patients receive VOWST as quickly as possible and provide compassion, care, and support to meet their individual needs."

Seres Therapeutics Named to TIME100 Most Influential Companies List

Retrieved on: 
Wednesday, June 21, 2023
Biotechnology, General Health, Pharmaceutical, Health, Clostridioides difficile infection, CDI, Therapy, David Berry (inventor), Infection, Centers for Disease Control and Prevention, CDC, Patient, Variometer, FDA, TIME, Regulation of tobacco by the U.S. Food and Drug Administration, Death, Food, Pharmaceutical industry

Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, has been named to the “TIME100 Most Influential Companies,” a list of 100 companies making an extraordinary impact around the world.

Key Points: 
  • Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, has been named to the “TIME100 Most Influential Companies,” a list of 100 companies making an extraordinary impact around the world.
  • To develop the list, TIME solicited company nominations from multiple sectors from its editors and correspondents, as well as from industry experts.
  • Since being founded over a decade ago, Seres has led the development of microbiome therapeutics as a novel medical modality.
  • Seres is also advancing a pipeline of microbiome therapeutics for the prevention of infectious diseases, and for other serious diseases.

Seres Therapeutics and Nestlé Health Science Present Late-Breaking Data on VOWST™, a Microbiota-Based Oral Therapeutic for Prevention of Recurrence of C. Difficile Infection in Adults, at ASM Microbe 2023

Retrieved on: 
Saturday, June 17, 2023
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The analysis was featured as a late-breaker Emerging Science presentation at American Society of Microbiology (ASM) Microbe 2023 being held in Houston, TX (June 15-19).

Key Points: 
  • The analysis was featured as a late-breaker Emerging Science presentation at American Society of Microbiology (ASM) Microbe 2023 being held in Houston, TX (June 15-19).
  • Results showed that at baseline (pre-treatment), individuals experiencing a first recurrence or multiple recurrences exhibited a similarly low degree of gut microbiome diversity.
  • Report any infection that is suspected to have been transmitted by VOWST to Aimmune Therapeutics, Inc. at 1-833-246-2566.
  • To report SUSPECTED ADVERSE REACTIONS, contact Aimmune Therapeutics at 1-833-AIM-2KNO (1-833-246-2566), or the FDA at 1-800-FDA-1088, or visit www.fda.gov/MedWatch .

Seres Therapeutics and Nestlé Health Science Announce U.S. Commercial Availability of VOWST™, the First and Only FDA-Approved Microbiota-Based Oral Therapeutic for Prevention of Recurrence of C. Difficile Infection

Retrieved on: 
Monday, June 5, 2023
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, FDA, Infectious Diseases, Infection, CDI, Food and Drug Administration, David Berry (inventor), Multimedia, Assistant, Medicine, Patient, Risk, Variometer, Therapy, Recurrence, Spore, Food, Weill Cornell Medicine, Pharmaceutical industry

Seres Therapeutics, Inc. (Nasdaq: MCRB) and Nestlé Health Science today announced that VOWST™ (fecal microbiota spores, live-brpk) is now commercially available for patients.

Key Points: 
  • Seres Therapeutics, Inc. (Nasdaq: MCRB) and Nestlé Health Science today announced that VOWST™ (fecal microbiota spores, live-brpk) is now commercially available for patients.
  • We look forward to helping patients who have this potentially life-threatening disease,” said Eric Shaff, President and Chief Executive Officer at Seres.
  • Report any infection that is suspected to have been transmitted by VOWST to Aimmune Therapeutics, Inc. at 1-833-246-2566.
  • To report SUSPECTED ADVERSE REACTIONS, contact Aimmune Therapeutics at 1-833-AIM-2KNO (1-833-246-2566), or the FDA at 1-800-FDA-1088, or visit www.fda.gov/MedWatch .