Hepatology

CymaBay Reports Fourth Quarter and Year Ended December 31, 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, February 28, 2024
Alkaline phosphatase, Acquisition, Liver, Child, Therapy, EMA, Ursodeoxycholic acid, New Drug Application, Gilead Sciences, Education, IDEAL, FDA, Science, Quality of life, Food, Marketing, U.S. FDA, Breakthrough, ALP, Hospital, PBC, Phase 3, Cirrhosis, Hepatology, Seladelpar, Safety, ULN, European Medicines Agency, Numerical, Patient, MHRA, UDCA, Itch, NDA, NRS, Pharmaceutical industry

NEWARK, Calif., Feb. 28, 2024 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced corporate updates and financial results for the year and fourth quarter ended December 31, 2023.

Key Points: 
  • NEWARK, Calif., Feb. 28, 2024 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced corporate updates and financial results for the year and fourth quarter ended December 31, 2023.
  • “2023 was a seminal year for CymaBay with critical achievements in the development of our investigational therapeutic, seladelpar.
  • Net loss for the year ended December 31, 2023 and 2022 was $105.4 million and $106.0 million, or ($0.99) and ($1.21) per share, respectively.
  • Net loss for the three months ended December 31, 2023 was higher than the three months ended December 31, 2022 primarily due to higher operating expenses.

Fujifilm Receives 510(k) Clearance for SCALE EYE®, a Novel Endoscopic Imaging Technology for Measuring Colonic Lesions

Retrieved on: 
Monday, February 26, 2024
Polyp (medicine), Colonoscopy, FDA, Polyp, EYE, Risk, Fujifilm, Colorectal polyp, PMID, Malignancy, Instrument, Subjectivity, NYU Langone Health, SCALE, Neoplasm, Hepatology

LEXINGTON, Mass., Feb. 26, 2024 (GLOBE NEWSWIRE) -- FUJIFILM Healthcare Americas Corporation, a leading provider of endoscopic imaging and endosurgical solutions, has been granted FDA 510(k) clearance for SCALE EYE, a new endoscopic imaging technology and part of its expanding ELUXEO Endoscopic Imaging System.

Key Points: 
  • LEXINGTON, Mass., Feb. 26, 2024 (GLOBE NEWSWIRE) -- FUJIFILM Healthcare Americas Corporation, a leading provider of endoscopic imaging and endosurgical solutions, has been granted FDA 510(k) clearance for SCALE EYE, a new endoscopic imaging technology and part of its expanding ELUXEO Endoscopic Imaging System.
  • Measurement time was 2.8 seconds using SCALE EYE, compared to 8 seconds when measuring with forceps.
  • Comparing size measurement of colorectal polyps using a novel virtual scale endoscope, endoscopic ruler or forceps: A preclinical randomized trial.
  • Introduction and preliminary evaluation of novel endoscope with pinpoint laser technology for adequate size estimation of colon lesions.

Ligand Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, February 27, 2024
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, MRK, Research, CRL, New Drug Application, Investment, Eisai, Growth, Sale, Parent, Novin, Focal segmental glomerulosclerosis, Streptococcus, LGND, FSGS, Breakthrough therapy, BLA, AED, GAAP, Therapy, NASH, Liver, NDA, Depreciation, Breast cancer, Total, Forecasting, Perampanel, Shanda, Telecanthus, ID, Retirement, PDUFA, Vaccine, Symantec Endpoint Protection, Type 2 diabetes, Safety, VRNA, Molluscum contagiosum, F2, Acquisition, Caregiver, Merck, AASLD, FDA, Telephone, Food, Pneumonia, Income tax, Hepatology, COVID-19, Element, Patient, SPA, Pharmaceutical industry

Royalties for the fourth quarter of 2023 were $22.5 million, compared with $22.0 million for the same period in 2022.

Key Points: 
  • Royalties for the fourth quarter of 2023 were $22.5 million, compared with $22.0 million for the same period in 2022.
  • Costs of Captisol sales were $1.6 million for the fourth quarter of 2023, compared with $21.6 million for the same period in 2022, with the decrease due to lower total Captisol sales during the fourth quarter of 2023 and $9.8 million in accelerated depreciation on Captisol manufacturing equipment during the fourth quarter of 2022.
  • Amortization of intangibles was $8.3 million for the fourth quarter of 2023, compared with $8.5 million for the same period in 2022.
  • Travere also announced fourth quarter 2023 results reporting that it received 459 new patient start forms for FILSPARI in the fourth quarter of 2023 and net product sales of $14.9 million for the fourth quarter.

Vir Biotechnology Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, February 22, 2024
Biotechnology, Pharmaceutical, AIDS, Health, COVID-19, Infectious Diseases, Health Technology, Clinical Trials, Infection, Bangladesh Technical Education Board, RSV, CHB, Influenza, Peginterferon-alfa, HIV Vaccine Trials Network, GSK, Research, Investment, AASLD, HDV, MBA, Cirrhosis, HHS, Administration, Conditional sentence, Hepatology, RNA, Respiratory syncytial virus, ASPR, COVID, Patient, Family, HCMV, Bill, Development, HIV, Pharmaceutical industry

Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate update and reported financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate update and reported financial results for the fourth quarter and full year ended December 31, 2023.
  • Complete 24-week treatment data for 30 participants per regimen is expected in the fourth quarter of 2024.
  • The MARCH Part B trial is ongoing with 48-week end of treatment data expected in the fourth quarter of 2024.
  • Revenues: Total revenues for the quarter ended December 31, 2023 were $16.8 million compared to $49.4 million for the same period in 2022.

New ICD-10-CM Code by the World Health Organization Paves the Way for Improved NAFLD Diagnostics Including ENDRA Life Sciences’ TAEUS System

Retrieved on: 
Wednesday, February 21, 2024
FDA, Health, Diabetes, Surgery, Health Insurance, Pharmaceutical, Therapy, CE, American Diabetes Association, NAFLD, Endocrinology, T2D, Research, Medicine, Person, CMS, Non-alcoholic fatty liver disease, Liver disease, NDRA, Prediabetes, Obesity, Cardiovascular disease, Food, ALT, De novo, Global health, Weill Cornell Medicine, Risk, Hepatology, Cirrhosis, European, Prevalence, Ultrasound, World Health Organization, Medicare, Type 2 diabetes, Metabolic syndrome, Patient, Fibrosis, Primary care, Fatty liver disease, NASH, Diagnosis, Knowledge Organization (journal), WHO, International Classification of Diseases, Dietary supplement

The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM), is a global coding system used to indicate a diagnosis for reimbursement purposes.

Key Points: 
  • The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM), is a global coding system used to indicate a diagnosis for reimbursement purposes.
  • These codes are issued by the World Health Organization (WHO) and are used to show payers why a particular service was medically necessary.
  • The inclusion of NAFLD under the ICD-10 K76.0 code facilitates standardized billing for its diagnosis.
  • "This positive development is testament to the growing awareness of liver health and the intensifying need for effective diagnostic solutions.

NorthSea Therapeutics Initiates Phase 2A Trial of Orziloben (NST-6179) in Intestinal Failure-Associated Liver Disease (IFALD)

Retrieved on: 
Wednesday, February 21, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Liver, Collagen, Myofibroblast, PD, Liver disease, Cirrhosis, Learning, Short bowel syndrome, Conference, Hepatology, Liver failure, Safety, Steatosis, Rigshospitalet, PN, Therapy, Pharmacokinetics, Cholestasis, Fatty liver disease, Patient, ASPEN, Fibrosis, Disease, NASH, Pharmaceutical industry

The trial is a randomized, double-blind, Phase 2a, placebo-controlled study, which will be conducted at multiple sites across North America.

Key Points: 
  • The trial is a randomized, double-blind, Phase 2a, placebo-controlled study, which will be conducted at multiple sites across North America.
  • It is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Orziloben in adult subjects with IFALD.
  • Commenting on the milestone, Rob de Ree, NST’s CEO, said: "Dosing the first patient in our Phase 2a trial for Orziloben in IFALD is a significant achievement for NorthSea Therapeutics, and is a testament to our commitment to advance innovative treatments for liver diseases.
  • In one pre-clinical model of PN-induced liver injury, Orziloben treatment completely prevented severe cholestasis and the development of fibrosis.

LISCure Biosciences Announces FDA Clearance of IND Application to Initiate a Phase 2 Study of LB-P8 for Primary Sclerosing Cholangitis (PSC)

Retrieved on: 
Thursday, February 29, 2024
PSC, Inflammation, AASLD, FDA, Physician, Food, Drug development, Part, Primary sclerosing cholangitis, Ascending cholangitis, ODD, Safety, Attention, Hepatology, Biomarker, Inflammatory bowel disease, Patient, Fibrosis, Clinical trial, IBD, IND, LBP, Pharmaceutical industry

LISCure anticipates treating the first patient in the upcoming months and expects topline results for Part 1 in the first half of 2025.

Key Points: 
  • LISCure anticipates treating the first patient in the upcoming months and expects topline results for Part 1 in the first half of 2025.
  • PSC is a rare, chronic, cholestatic liver disease with very high unmet medical needs where there are no approved drugs.
  • LISCure confirmed the safety, tolerability, and key biomarkers of LB-P8 in a Phase 1 study and received Orphan Drug Designation (ODD) for the treatment of PSC from the U.S. FDA.
  • LB-P8 was presented in oral presentations at the American Association for the Study of Liver Diseases (AASLD) every year for the past two years.

Echosens Raises the Standard for Liver Disease Assessment with Next Generation FibroScan®

Retrieved on: 
Monday, February 26, 2024
Liver, Anxiety, Liver disease, Physician, Obesity, MAFLD, Growth, Learning curve, Health care, Hepatology, MASH, Elastography, Gold, Health, Automation, Patient, Diagnosis, Workflow, Medical imaging

WALTHAM, Mass., Feb. 26, 2024 /PRNewswire/ -- More than 100 million people in the U.S. are affected by some form of liver disease, but only 4.5 million adults have been diagnosed with the condition. Responding to the dire need for enhanced liver health management, Echosens, the leader in liver health, introduces its new Guided Vibration-Controlled Transient Elastography (VCTE)™ technology, available only on new FibroScan® systems. An essential tool in the battle against liver disease, this next-gen FibroScan launch meets the urgent need for precise, efficient, and non-invasive liver assessment, delivering on the needs of healthcare professionals at the forefront of patient care.

Key Points: 
  • An essential tool in the battle against liver disease, this next-gen FibroScan launch meets the urgent need for precise, efficient, and non-invasive liver assessment, delivering on the needs of healthcare professionals at the forefront of patient care.
  • This innovation elevates liver care standards, assuring top-tier disease assessment for all patients, including obese patients, where assessments were previously limited."
  • As the global leader in liver health, Echosens is committed to empowering healthcare professionals with the gold standard non-invasive solution for the comprehensive management of liver health.
  • This evolution signifies a leap forward in simplifying diagnosis and disease management – making liver assessments more accessible and seamlessly integrated in practices than ever before.

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.

Nanox Receives FDA Clearance for HealthFLD, an Advanced AI-Based Software Empowering Clinicians in Assessment of Fatty Liver

Retrieved on: 
Tuesday, February 13, 2024
DSM-IV codes, Non-alcoholic fatty liver disease, Coronary artery disease, NAFLD, CT scan, Spine, Artificial intelligence, AI, MD, Osteoporosis, American Journal, Obesity, FDA, Cardiovascular disease, Food, Abdomen, Risk, Cirrhosis, Hepatology, Liver disease, Prevalence, University, MASH, Type 2 diabetes, AJR, Death, The Company, Patient, Diagnosis, Software, CAC, Medicine, Medical imaging

PETACH TIKVA, Israel, Feb. 13, 2024 (GLOBE NEWSWIRE) -- ("Nanox" or the "Company," Nasdaq: NNOX), an innovative medical imaging technology company, today announced that its deep-learning medical imaging analytics subsidiary, Nanox AI Ltd., received 510(k) clearance by the U.S. Food and Drug Administration (FDA) for HealthFLD, an artificial intelligence (AI) software that provides automated qualitative and quantitative analysis of liver attenuation from routine contrast and non-contrast chest and abdomen CT scans in patients between the ages of 18 to 75. HealthFLD is intended to support clinicians in the detection of fatty liver, correlated with hepatic steatosis, an early sign of metabolic dysfunction-associated steatotic liver disease (MASLD), formerly referred to as non-alcoholic fatty liver disease (NAFLD).

Key Points: 
  • HealthFLD is intended to support clinicians in the detection of fatty liver, correlated with hepatic steatosis, an early sign of metabolic dysfunction-associated steatotic liver disease (MASLD), formerly referred to as non-alcoholic fatty liver disease (NAFLD).
  • MASLD is commonly asymptomatic until it progresses to advanced liver fibrosis, and the current gold standard for diagnosis is a liver biopsy, which is invasive and costly.
  • HealthFLD was designed to help clinicians in the assessment and analysis of fatty liver in the general population from routine CT scans.
  • It’s promising to have a liver solution available that may help evaluate early signs of illness from routine imaging.”
    The HealthFLD clearance is the third product across the Nanox AI suite of population health solutions to receive FDA clearance.