EASL

Aligos Therapeutics Reports Recent Business Progress and Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, March 12, 2024
Research, Hepatitis, CAM, Stop, KU Leuven, AASLD, Annual general meeting, SAN, EASL, MASH, MBA, Hepatology, Investment, Clinical trial, Therapy, Phase II, Interim, ECCMID, Infection, CHB, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., March 12, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today reported recent business progress and financial results for the fourth quarter and full year 2023.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., March 12, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today reported recent business progress and financial results for the fourth quarter and full year 2023.
  • R&D expenses for the year ended December 31, 2023, were $73.0 million, compared with $85.1 million for the same period of 2022.
  • G&A expenses for the year ended December 31, 2023, were $30.6 million, compared with $26.4 million for the same period of 2022.
  • Total G&A stock-based compensation expense incurred for the year ended December 31, 2023 was $5.8 million, compared with $6.7 million for the same period of 2022.

Arbutus Reports Fourth Quarter and Year End 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, February 29, 2024
LNP, HBV, Court, PD, Research, Virology, Expert witness, CFBV, AASLD, Construction, Nivolumab, Investment, Arbutus, HBsAg, EASL, Vaccine, Interim, Safety, COVID-19, Pharmacokinetics, Roivant Sciences, Patient, Clinical trial, Congress, RNA interference, DNA, Pharmaceutical industry

Arbutus plans to announce end-of-treatment data from this trial in the first half of 2024.

Key Points: 
  • Arbutus plans to announce end-of-treatment data from this trial in the first half of 2024.
  • Arbutus plans to announce end-of-treatment data from this portion of the trial in the first half of 2024.
  • Arbutus is advancing AB-101 into part two of this clinical trial which involves dosing healthy subjects with multiple-ascending doses of AB-101.
  • Roivant Sciences Ltd. owned approximately 23% of the Company’s outstanding common shares as of December 31, 2023.

Medivir to present clinical pharmacokinetic data at EASL Liver Cancer Summit, further supporting the continued development of fostrox

Retrieved on: 
Monday, January 15, 2024
Patient, HCC, Poster, Cancer, EASL, Hepatocellular carcinoma, Liver cancer, Medivir, Pharmaceutical industry

STOCKHOLM, Jan. 15, 2024 /PRNewswire/ -- Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that clinical pharmacokinetic (PK) data from the first study with fostroxacitabine bralpamide (fostrox) (NCT03781934) will be presented at the European Association for the Study of the Liver (EASL) Liver Cancer Summit in February 22-24, 2024 in Rotterdam.

Key Points: 
  • STOCKHOLM, Jan. 15, 2024 /PRNewswire/ -- Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that clinical pharmacokinetic (PK) data from the first study with fostroxacitabine bralpamide (fostrox) (NCT03781934) will be presented at the European Association for the Study of the Liver (EASL) Liver Cancer Summit in February 22-24, 2024 in Rotterdam.
  • The abstract, titled 'Population pharmacokinetic modeling of orally administered fostroxacitabine bralpamide (fostrox, MIV-818) and its metabolite troxacitabine in a phase I/IIa liver cancer study' will be presented at the conference by Karin Tunblad PhD, Project Director for fostrox at Medivir.
  • The presentation will include pharmacokinetic results from 42 patients in the phase I/IIa clinical study with fostrox monotherapy and the fostrox + Lenvima® combination, supporting regulatory interactions and further strengthening the continued development of fostrox in patients with hepatocellular carcinoma (HCC).
  • The abstract and the poster will be available on Medivir's website after the presentation.

Arbutus Announces 2024 Corporate Objectives and Provides Financial Update

Retrieved on: 
Monday, January 8, 2024
LNP, RNA interference, AASLD, Virology, HBV, Vaccine, Court, Nivolumab, Congress, Clinical trial, Pharmacokinetics, PD, Expert witness, Arbutus, COVID-19, EASL, CFBV, Interim, Investment, Patient, Safety, HBsAg, PD-L1, Pharmaceutical industry

Arbutus plans to announce end-of-treatment data from this trial in the first half of 2024.

Key Points: 
  • Arbutus plans to announce end-of-treatment data from this trial in the first half of 2024.
  • Arbutus plans to announce end-of-treatment data from this portion of the trial in the first half of 2024.
  • Arbutus expects to report preliminary data from the healthy subject portion of this clinical trial, including target engagement and receptor occupancy data, in the first half of 2024.
  • With respect to the Moderna lawsuit, fact discovery is currently on-going with the claim construction hearing scheduled for February 8, 2024.

Ipsen confirms U.S. FDA grants priority review for New Drug Application for elafibranor for the treatment of rare cholestatic liver disease, PBC

Retrieved on: 
Thursday, December 7, 2023
Liver, UDCA, Chapter Two, Woman, FDA, MAA, Fatigue, Nausea, Primary biliary cholangitis, Inflammation, ADR, Patent, Liver disease, Diagnosis, AMF, CHMP, Ascending cholangitis, UCD, Business, ACLF, PDUFA, Itch, Risk, New Drug Application, OA, Common, EASL, MASH, Liver failure, Safety, Ammonia, Elafibranor, Therapy, Epidemiology, History, Patient, Cholangiocarcinoma, Food, Health care, EMA, Ursodeoxycholic acid, MHRA, Cirrhosis, Medicine, NTZ, EVP, Cholestasis, NASH, Research, Diarrhea, Bile, NDA, PBC, Abdominal pain, Clinical trial, European Medicines Agency, IPN, PPAR, P10, CCA, Fibrosis, Pharmaceutical industry

An oral, once-daily dual peroxisome activated receptor alpha/delta (PPAR α,δ) agonist, investigational elafibranor could potentially be the first novel second-line treatment for the rare, cholestatic liver disease, PBC, in nearly a decade.

Key Points: 
  • An oral, once-daily dual peroxisome activated receptor alpha/delta (PPAR α,δ) agonist, investigational elafibranor could potentially be the first novel second-line treatment for the rare, cholestatic liver disease, PBC, in nearly a decade.
  • The trial enrolled 161 patients who were randomized 2:1 to receive either elafibranor 80mg once daily or placebo.
  • ELATIVE also investigated the effect of treatment with elafibranor on pruritus (severe itch), a significant symptom burden amongst people living with PBC.
  • Findings from the secondary endpoint using the PBC Worst Itch NRS score, showed a reduction in pruritis for elafibranor, which was not statistically significant.

CymaBay Presents Results on the Potential of Seladelpar in Treatment of Patients with Primary Biliary Cholangitis at ACG 2023

Retrieved on: 
Monday, October 23, 2023
Ethnographic Museum of the University of Zurich, Patient, American College, IL-31, Itch, UDCA, The Duke of Edinburgh's International Award - Canada, Hope, Pathology, Conditional sentence, NRS, Liver, ALP, American College of Gastroenterology, HIV disease progression rates, PBC, Ursodeoxycholic acid, Risk, European Association for the Study of the Liver, Research and development, Cholestatic pruritus, Alkaline phosphatase, Primary biliary cholangitis, University, EASL, Cholestasis, Atopic dermatitis, Therapy, Doctor of Philosophy, Pharmaceutical industry, Research, MD

VANCOUVER, British Columbia, Oct. 23, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, announced today the presentation of findings from its post-hoc analysis of the Phase 3 ENHANCE study of seladelpar for the treatment of primary biliary cholangitis (PBC), showing baseline intensity of patient-reported pruritus was associated with higher levels of serum IL-31. The presentation, named the recipient of this year’s International Award by the American College of Gastroenterology, will be presented by Professor Andreas E. Kremer, MD, Ph.D., MHBA, a leading authority in cholestatic pruritus from the University of Zurich. Featured results included novel aspects of the anti-pruritic and anti-cholestatic mechanisms of seladelpar, CymaBay’s first-in-class oral, selective PPARδ agonist, or "delpar," being investigated for the treatment of patients with PBC.

Key Points: 
  • Featured results included novel aspects of the anti-pruritic and anti-cholestatic mechanisms of seladelpar, CymaBay’s first-in-class oral, selective PPARδ agonist, or "delpar," being investigated for the treatment of patients with PBC.
  • The data were previously presented at the European Association for the Study of the Liver (EASL)’s The International Liver Congress™ 2023 in Vienna, Austria.
  • “These results offer a glimmer of hope in that they link IL-31 levels in patients with PBC to itch.
  • Elevated risk due to ELF was identified in 43.2% of patients who currently meet guidelines for second-line treatment vs. 27.2% within patient groups not recommended for second-line treatment.

Fibronostics Announces Partnership with Stone Diagnostics

Retrieved on: 
Tuesday, October 10, 2023
Partnership, Social prescribing, Guideline, United, Health care, Biomarker, Customer support, Prevalence, AI, ROSA, Liver, Chronic liver disease, AASLD, Rock (geology), Chemistry, Growth, Biopsy, Patient, End organ damage, Steatosis, Fibrosis, DSM-IV codes, Physician, Liver disease, EASL, MAFLD, Medical imaging, Medical device

SANTA ROSA BEACH, Fla. and SINGAPORE, Oct. 10, 2023 /PRNewswire/ -- Fibronostics , a global leader in non-invasive, AI-driven diagnostic testing for *MAFLD/MASH patients, announced today a strategic partnership with Stone Diagnostics, a leading provider of laboratory services in the United States.

Key Points: 
  • SANTA ROSA BEACH, Fla. and SINGAPORE, Oct. 10, 2023 /PRNewswire/ -- Fibronostics , a global leader in non-invasive, AI-driven diagnostic testing for *MAFLD/MASH patients, announced today a strategic partnership with Stone Diagnostics, a leading provider of laboratory services in the United States.
  • Stone Diagnostics will provide Physicians and their patients end to end service to enable Physicians to assess chronic liver disease with Fibronostics' benchmark product, LIVERFASt™.
  • Stone Diagnostics' combination of scaled operational excellence and leading digital capabilities leveraging MyHealthAI is ideal and vital to serve doctors using LIVERFASt™ to screen, identify and monitor *MAFLD/MASH patients.
  • "We are delighted to partner with Stone Diagnostics to provide LIVERFASt™ to the medical community", said Fibronostics CEO Sven Henrichwark.

Sequana Medical announces H1 2023 results and provides business update

Retrieved on: 
Thursday, September 14, 2023
Overload, Congestion, EASL, Heart failure, Liver disease, Peritoneal dialysis, Safety, Survival, Cancer, Quality of life, Sheep, Congress, DSR, Data monitoring committee, PMA, Animal, Patient, Brussels Stock Exchange, Kidney, Ascites, Mouse, 2.0, Principal, Cirrhosis, FDA, Health, Pharmaceutical industry, Management

Ghent, Belgium – 14 September 2023 – Sequana Medical NV (Euronext Brussels: SEQUA) (the "Company" or "Sequana Medical"), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today announces its business highlights and financial results for the six-month period ending 30 June 2023 and its outlook for the remainder of the year.

Key Points: 
  • Ghent, Belgium – 14 September 2023 – Sequana Medical NV (Euronext Brussels: SEQUA) (the "Company" or "Sequana Medical"), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today announces its business highlights and financial results for the six-month period ending 30 June 2023 and its outlook for the remainder of the year.
  • Ian Crosbie, Chief Executive Officer at Sequana Medical, commented: “During the first half of this year, we made strong progress in both our alfapump and DSR programs.
  • “Our alfapump liver program is advancing towards North American commercialization with filing of the PMA with the FDA planned by year end.
  • Total liquidity position of €17.1 million at the end of June 2023 compared to €18.9 million at the end of December 2022.

Abstract for ENDRA Life Sciences' TAEUS System Accepted for Presentation at EASL Steatotic Liver Disease Summit 2023

Retrieved on: 
Thursday, September 7, 2023
Research, Medical Devices, Clinical Trials, Health Technology, Other Health, Biotechnology, General Health, Health, Science, Other Science, Proton, Fatty liver disease, EASL, NASH, Fibrosis, NDRA, Poster, European Association for the Study of the Liver, Magnetic resonance imaging, Medical imaging, Czechoslovakia, Liver

ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today announced the acceptance of a clinical abstract titled “Thermoacoustic assessment of fatty liver disease - a clinical feasibility study” for presentation at the Steatotic Liver Disease Summit™ 2023 hosted by the European Association for the Study of the Liver (EASL), taking place September 21-23 in Prague, Czechoslovakia.

Key Points: 
  • ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today announced the acceptance of a clinical abstract titled “Thermoacoustic assessment of fatty liver disease - a clinical feasibility study” for presentation at the Steatotic Liver Disease Summit™ 2023 hosted by the European Association for the Study of the Liver (EASL), taking place September 21-23 in Prague, Czechoslovakia.
  • “This poster presentation is focused on a comparison of TAEUS estimates of liver fat fraction to the established clinical gold standard of Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF).
  • We are delighted that ENDRA's clinical abstract was accepted by EASL for its annual summit focused on steatotic liver disease, which is the target of ENDRA's first TAEUS application.
  • The study data add to ENDRA's growing clinical evidence and illustrate TAEUS' potential to assess fatty liver disease, non-invasively, at the point of care, in populations that include large subjects, and those with NASH or fibrosis,” stated Michael Thornton, Chief Technology Officer of ENDRA.

Sagimet Biosciences Reports Second Quarter 2023 Financial Results and Provides Corporate Updates

Retrieved on: 
Monday, August 21, 2023
Exercise, EASL, IPO, Therapy, NASH, Patient, SAN, Biopsy, Pharmaceutical industry

SAN MATEO, Calif., Aug. 21, 2023 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic pathways, today reported financial results for the second quarter ended June 30, 2023, and provided recent corporate updates.

Key Points: 
  • SAN MATEO, Calif., Aug. 21, 2023 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic pathways, today reported financial results for the second quarter ended June 30, 2023, and provided recent corporate updates.
  • Financial Results for the Three Months Ended June 30, 2023
    Cash and cash equivalents for the second quarter ended June 30, 2023 were $18.5 million as of June 30, 2023.
  • Research and development (R&D) expense for the second quarter ended June 30, 2023 was $4.7 million compared to $6.4 million for the second quarter of 2022.
  • Net loss for the second quarter ended June 30, 2023 was $6.8 million compared to a net loss of $7.1 million for the second quarter of 2022.