United European Gastroenterology

Ironwood Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Results; Achieves 2023 Financial Guidance

Retrieved on: 
Thursday, February 15, 2024
Managed Care, Biotechnology, Pharmaceutical, Health, Acquisition, Liver, Autoimmune disease, Income tax, Hepatology, FDA, Food, Endometriosis, PBC, Interest expense, Constipation, Annual general meeting, Short bowel syndrome, Safety, Society, GAAP, The Lancet, UEG, Pharmacokinetics, Food and Drug Administration, Primary biliary cholangitis, Interest, Patient, Disease, STARS, Phase, Interstitial cystitis, Trial of the century, Ageing, United European Gastroenterology, CIC, Research, SBS, Depreciation, Video game

Total revenues in the fourth quarter of 2023 were $117.6 million, compared to $107.2 million in the fourth quarter of 2022.

Key Points: 
  • Total revenues in the fourth quarter of 2023 were $117.6 million, compared to $107.2 million in the fourth quarter of 2022.
  • Operating expenses in the fourth quarter of 2023 were $80.0 million, compared to $38.8 million in the fourth quarter of 2022.
  • Adjusted EBITDA was $39.9 million in the fourth quarter of 2023, compared to $68.7 million in the fourth quarter of 2022.
  • Ironwood generated $35.8 million in cash from operations in the fourth quarter of 2023, compared to $79.2 million in cash from operations in the fourth quarter of 2022.

Motus GI Holdings Publishes Positive Results from a European Study of the Second Generation Pure-Vu System in Improving Visualization for Colonoscopy in Patients with a History of Poor Bowel Preparation

Retrieved on: 
Tuesday, January 30, 2024
Manuscript, United European Gastroenterology, History, MOTS, Patient, BCS, FDA, Motus, UGE, Hospital, Medical device

The Company’s Pure-Vu System is an FDA-approved and CE-certified bowel cleansing system (BCS) intended to increase visualization in inadequately prepared colons by offering intraprocedural cleansing.

Key Points: 
  • The Company’s Pure-Vu System is an FDA-approved and CE-certified bowel cleansing system (BCS) intended to increase visualization in inadequately prepared colons by offering intraprocedural cleansing.
  • “We are excited to see the positive results from this European study published in the UGE Journal, further building upon the extensive portfolio of study data and user experiences for the second generation Pure-Vu System.
  • This study concluded that adequate bowel cleaning can be achieved in patients with a history of inadequate bowel preparation by using the Pure-Vu System.
  • The study enrolled a total of 44 patients with previous poor bowel preparation (BBPS

Landos Biopharma Provides Company Update and Reports Third Quarter 2023 Results

Retrieved on: 
Thursday, November 9, 2023
Research, United European Gastroenterology, American College, NLRX1, UC, D&O, Biomarker, NEXUS, ACG, Wind, American College of Gastroenterology, D, Poster, Ulcerative colitis, Inflammatory bowel disease, LTE, UZ Leuven, KU Leuven, Pharmacokinetics, Clinical trial, Epithelium, Ulcer, Safety, Patient, Gene expression, Pharmaceutical industry

NEW YORK, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ: LABP), a clinical-stage biopharmaceutical company developing novel, oral medicines for patients with autoimmune diseases, today provided a business update and announced financial results for the quarter ended September 30, 2023.

Key Points: 
  • NEW YORK, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ: LABP), a clinical-stage biopharmaceutical company developing novel, oral medicines for patients with autoimmune diseases, today provided a business update and announced financial results for the quarter ended September 30, 2023.
  • NEXUS Phase 2 proof-of-concept clinical trial:
    The NEXUS trial of NX-13 remains on track as the Company continues to recruit, screen and randomize patients for the trial.
  • Research and development expenses were $3.1 million for the third quarter of 2023, compared to $4.9 million for the third quarter of 2022.
  • General and administrative expenses were $2.1 million for the third quarter of 2023, compared to $3.0 million for the third quarter of 2022.

Ironwood Pharmaceuticals Reports Third Quarter 2023 Results

Retrieved on: 
Thursday, November 9, 2023
Research, FDA, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Other Science, Science, Graft-versus-host disease, United European Gastroenterology, Short bowel syndrome, Constipation, Trial of the century, Income tax, Interstitial cystitis, Hepatology, Interest expense, EBITDA, Test Claimants in the Franked Investment Income Group Litigation v IRC, Liver, STARS, GAAP, Acquisition, SBS, Interest, PBC, Society, Pharmacokinetics, Phase, Clinical trial, Annual general meeting, Primary biliary cholangitis, Autoimmune disease, Depreciation, UEG, Safety, Total, CIC, Patient, Endometriosis, Pharmaceutical industry, Vaccine, Video game, Bookkeeping, Reinsurance, Bank, Ironwood, Nutrition

Total revenues in the third quarter of 2023 were $113.7 million, compared to $108.6 million in the third quarter of 2022.

Key Points: 
  • Total revenues in the third quarter of 2023 were $113.7 million, compared to $108.6 million in the third quarter of 2022.
  • Operating expenses in the third quarter of 2023 were $73.7 million, compared to $40.2 million in the third quarter of 2022.
  • Adjusted EBITDA was $49.1 million in the third quarter of 2023, compared to $68.8 million in the third quarter of 2022.
  • – Ironwood generated approximately $32.5 million in cash from operations in the third quarter of 2023, compared to $69.1 million in cash from operations in the third quarter of 2022.

Schrödinger Reports Third Quarter 2023 Financial Results

Retrieved on: 
Wednesday, November 1, 2023
Software, Biotechnology, Pharmaceutical, Oncology, General Health, Health, Technology, Clinical Trials, United European Gastroenterology, PH, PRMT5, Trial of the century, Global health, IND, Acute myeloid leukemia, MALT1, Food, PKA, FEP, Myelodysplastic syndrome, Regulation of tobacco by the U.S. Food and Drug Administration, GAAP, Mantle cell lymphoma, Research, Bill, Ulcerative colitis, Bill & Melinda Gates Foundation, Pharmacokinetics, CDC7, Phases of clinical research, Webcast, ADMET, UEG, Safety, Overweight, Therapy, Investment, Table, Patient, Cryptocurrency, Pharmaceutical industry, Bank, EU

Schrödinger today updated its financial guidance for 2023.

Key Points: 
  • Schrödinger today updated its financial guidance for 2023.
  • The Phase 1 dose-escalation study in healthy volunteers is nearing completion, and the company expects to report data from the study in the fourth quarter of 2023.
  • Schrödinger will host a conference call to discuss its third quarter 2023 financial results on Wednesday, November 1, 2023, at 4:30 p.m.
  • Schrödinger will host its Pipeline Day in New York City on Thursday, December 14, 2023, beginning at 10:00 a.m.

Mainz Biomed to Showcase ColoAlert® at UEG Week 2023 in Copenhagen, Denmark

Retrieved on: 
Wednesday, October 11, 2023
Partnership, Colorectal cancer, United European Gastroenterology, Oncology, Thomas Jefferson National Accelerator Facility, CRC, Cancer, Gastroenterology

BERKELEY, Calif. and MAINZ, Germany, Oct. 11, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a leading molecular genetics diagnostic company focused on early cancer detection, announced today its participation in the upcoming UEG Week.

Key Points: 
  • BERKELEY, Calif. and MAINZ, Germany, Oct. 11, 2023 (GLOBE NEWSWIRE) -- Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a leading molecular genetics diagnostic company focused on early cancer detection, announced today its participation in the upcoming UEG Week.
  • This prominent event, organized by the United European Gastroenterology and scheduled to take place in Copenhagen, Denmark, from October 14th to 17th, serves as a premier platform for discussing the latest advancements and breakthroughs in the field of gastroenterology.
  • Recognized as a key gathering in the field, UEG Week addresses critical issues in gastroenterology, providing an ideal opportunity for Mainz Biomed to engage with international gastroenterologists, oncologists, and stakeholders interested in advancing the early detection of colorectal cancer (CRC).
  • Mainz Biomed team members will be available throughout the event showcasing ColoAlert® the Company’s flagship product, a highly effective and user-friendly at-home detection test for colorectal cancer (CRC).

EQS-News: Immunic Presents Data From Phase 2 CALDOSE-1 Trial of Vidofludimus Calcium in Ulcerative Colitis at the United European Gastroenterology Week 2023

Retrieved on: 
Tuesday, October 17, 2023
UC, IBD, Safety, United European Gastroenterology, Biotechnology, Ulcerative colitis, Maintenance, Metabolism, Inflammatory bowel disease, Hepatology, Gastroenterology, Immune Therapy Holdings, Patient, Pharmaceutical industry

The data, therefore, validates the potential of vidofludimus calcium in UC and other inflammatory bowel disease indications.”

Key Points: 
  • The data, therefore, validates the potential of vidofludimus calcium in UC and other inflammatory bowel disease indications.”
    The CALDOSE-1 trial of vidofludimus calcium in moderate-to-severe ulcerative colitis (UC) was a phase 2b, multicenter, randomized, double-blind, placebo-controlled, dose-finding study, including a blinded 10-week induction phase and a blinded 50-week maintenance phase.
  • Similarly, patients treated with vidofludimus calcium achieved dose-linear increases in steroid-free clinical remission, endoscopic healing and microscopic healing.
  • An exploratory statistical analysis showed superiority of the 30 mg vidofludimus calcium treatment group over placebo for both clinical remission (p=0.0358) and endoscopic healing (p=0.0259).
  • Consistent with prior data sets in other patient populations, administration of vidofludimus calcium in this trial was found to be safe and well-tolerated.

EQS-News: Immunic Presents Data From Phase 1b Clinical Trial of IMU-856 in Celiac Disease at the United European Gastroenterology Week 2023

Retrieved on: 
Tuesday, October 17, 2023
Histology, Coeliac disease, Irritable bowel syndrome, Pharmacokinetics, Biomarker, Abstract, Treatment, Physical examination, Human, Safety, United European Gastroenterology, Biotechnology, Vital signs, Ulcerative colitis, Clinical trial, Regeneration, Patient, SIRT6, Pharmaceutical industry, Short course immune induction therapy

In this phase 1b, double-blind, randomized, placebo-controlled trial in patients with celiac disease, IMU‑856 showed positive effects over placebo in four key dimensions of clinical outcome: protection of the gut architecture, improvement of patients’ symptoms, biomarker response and enhancement of nutrient absorption.

Key Points: 
  • In this phase 1b, double-blind, randomized, placebo-controlled trial in patients with celiac disease, IMU‑856 showed positive effects over placebo in four key dimensions of clinical outcome: protection of the gut architecture, improvement of patients’ symptoms, biomarker response and enhancement of nutrient absorption.
  • IMU-856 was also found to be safe and well-tolerated with a benign adverse event profile and with pharmacokinetics that allow once-daily dosing.
  • There were no systematic clinically relevant findings relative to safety and tolerability, as assessed by physical examination, clinical laboratory tests, vital signs, and 12-lead electrocardiograms.
  • “In our phase 1b clinical trial, IMU-856 showed the first clinical signals of its potential ability to restore a healthy gut by renewal of the gut wall in patients with celiac disease.

EQS-News: Mainz Biomed to Showcase ColoAlert® at UEG Week 2023 in Copenhagen, Denmark

Retrieved on: 
Tuesday, October 17, 2023
Partnership, Oncology, Thomas Jefferson National Accelerator Facility, United European Gastroenterology, Showcase, CRC, Cancer, Colorectal cancer, UEG, Gastroenterology

Mainz Biomed to Showcase ColoAlert® at UEG Week 2023 in Copenhagen, Denmark

Key Points: 
  • Mainz Biomed to Showcase ColoAlert® at UEG Week 2023 in Copenhagen, Denmark
    The issuer is solely responsible for the content of this announcement.
  • Mainz Biomed to Showcase ColoAlert® at UEG Week 2023 in Copenhagen, Denmark
    Mainz Biomed team members will be available throughout the event at the Company’s booth located in Hall C, Stand C3-92
    BERKELEY, US – MAINZ, Germany – October 11, 2023 — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a leading molecular genetics diagnostic company focused on early cancer detection, announced today its participation in the upcoming UEG Week.
  • Recognized as a key gathering in the field, UEG Week addresses critical issues in gastroenterology, providing an ideal opportunity for Mainz Biomed to engage with international gastroenterologists, oncologists, and stakeholders interested in advancing the early detection of colorectal cancer (CRC).
  • Mainz Biomed team members will be available throughout the event showcasing ColoAlert® the Company’s flagship product, a highly effective and user-friendly at-home detection test for colorectal cancer (CRC).

Data Presented at UEG Week 2023 Further Support the Potential of Celltrion’s Investigational Subcutaneous Infliximab CT-P13 SC in the Treatment of Inflammatory Bowel Disease

Retrieved on: 
Monday, October 16, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Incidence, European Commission, Health care, United European Gastroenterology, Northwestern Medicine, Feinberg School of Medicine, Mayo, CD, Aes, MD, BLA, IBD, Crohn's disease, Safety, Medicine, Ulcerative colitis, Patient, FDA, Biologics license application, Celltrion, CDAI, Maintenance, Infliximab, Inflammatory bowel disease, UEG, Infection, Pharmaceutical industry, Medical imaging, UC

The proportion of patients who experienced adverse events (AEs), serious AEs, infection in the SC infliximab and placebo groups were generally comparable.

Key Points: 
  • The proportion of patients who experienced adverse events (AEs), serious AEs, infection in the SC infliximab and placebo groups were generally comparable.
  • If approved by the FDA, CT-P13 SC would be the first subcutaneous formulation of infliximab.
  • Post-hoc analyses of the LIBERTY-CD and LIBERTY-UC studies were presented as posters at UEG Week 2023.
  • The first post-hoc analysis examined the possible use of SC infliximab treatment without immunosuppressants and the second evaluated dose escalation in patients with loss of treatment response.