Hepatology

Viking Therapeutics Presents New Data from Phase 2b VOYAGE Study of VK2809 in Patients with Biopsy-Confirmed Non-Alcoholic Steatohepatitis (NASH) at The Liver Meeting® 2023

Retrieved on: 
Monday, November 13, 2023
Hepatology, Magnetic resonance imaging, Therapy, AASLD, Patient, Type 2 diabetes, Fibrosis, Liver, Vikings, NASH, F2, Medical imaging, Pharmaceutical industry, Boston

SAN DIEGO, Nov. 13, 2023 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced the presentation of new results from the ongoing Phase 2b clinical trial of VK2809, the company's novel liver-selective thyroid hormone receptor beta agonist, in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH). The latest findings from the VOYAGE study were featured in a late breaking poster presentation at the Liver Meeting® 2023, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), which is being held November 10-14, 2023, in Boston.

Key Points: 
  • The latest findings from the VOYAGE study were featured in a late breaking poster presentation at the Liver Meeting® 2023, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), which is being held November 10-14, 2023, in Boston.
  • As previously reported, the VOYAGE study successfully achieved its primary endpoint, with patients receiving VK2809 experiencing statistically significant reductions in liver fat content from baseline to Week 12 as compared with placebo.
  • Newly reported findings demonstrated robust and comparable liver fat reductions among patients with or without type 2 diabetes, as well as patients with either F2 or F3 fibrosis.
  • The median relative reduction from baseline in liver fat ranged from 38% to 55% for patients receiving VK2809.

Lipocine Releases Late Breaking Presentation on LPCN 1148 Phase 2 Results at The Liver Meeting® 2023

Retrieved on: 
Monday, November 13, 2023
CNS, Hepatology, Safety, AASLD, Patient, Virginia Commonwealth University, OLE, Liver disease, Liver, NCT, Cirrhosis, MD, Hepatic encephalopathy, Central nervous system, Pharmaceutical industry

SALT LAKE CITY, Nov. 13, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that results of its Phase 2 study evaluating LPCN 1148 are being presented at The American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2023, taking place in Boston MA. The results are featured in a late-breaking oral presentation and e-poster by Dr. Arun Sanyal, MD, Director, Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University, advisor to Lipocine.

Key Points: 
  • The results are featured in a late-breaking oral presentation and e-poster by Dr. Arun Sanyal, MD, Director, Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University, advisor to Lipocine.
  • "We are very pleased to share the data from our successful Phase 2 study of LPCN 1148 with the hepatology community at this year's Liver Meeting," said Dr. Mahesh Patel, President and CEO of Lipocine.
  • "The data show that LPCN 1148 improved multiple additional clinically meaningful and surrogate outcomes, including hepatic encephalopathy.
  • After week 24, all patients enter a single arm open-label extension ("OLE") stage of the study and receive LPCN 1148.

TARGET-NASH Offers Unprecedented Glimpse into Growing Public Health Concerns with Few Treatment Options

Retrieved on: 
Monday, November 13, 2023
Calibration, Hepatology, Research, Entrepreneurship, AASLD, Liver disease, Fatty liver disease, Patient, Metabolism, Liver, Cirrhosis, PRO, MASH, American Heart, Target, Public, RWE, American Heart Association, Dietary supplement, Medical imaging, Pharmaceutical industry, Boston

DURHAM, N.C., Nov. 13, 2023 /PRNewswire/ -- In response to the growing unmet need for real-world evidence (RWE) surrounding metabolic liver diseases, industry leader Target RWE released new updates on TARGET-NASH, one of the largest real-world datasets of its kind.

Key Points: 
  • 15% have been treated or are currently being treated with a GLP-1 receptor agonist.
  • The TARGET-NASH longitudinal registry has enrolled more than 7,000 patients in the U.S. and Europe, with approximately 750 pediatric patients.
  • "Metabolic liver diseases are some of the most concerning public health concerns facing populations around the world.
  • Until now, stakeholders had little access to treatment patterns for this complex patient population being treated for multiple co-morbidities."

Target RWE Releases Important Updates on the Cirrhosis Quality Collaborative/TARGET-Liver Disease Partnership with the American Association for the Study of Liver Diseases

Retrieved on: 
Friday, November 10, 2023
MSHS, Calibration, Disease, Hepatology, Safety, Prevalence, Entrepreneurship, AASLD, CQC, Liver disease, Mortality, Chief Medical Officer (Ireland), Fatty liver disease, Patient, Liver, Cirrhosis, TARGET, Chronic liver disease, Partnership, Quality of life, LD, American Heart, RWE, American Heart Association, Pharmaceutical industry, Boston

DURHAM, N.C., Nov. 10, 2023 /PRNewswire/ -- Real-world evidence (RWE) leader Target RWE announced today that the CQC and TARGET-Liver Disease (LD) partnership with the American Association for the Study of Liver Diseases (AASLD) has enrolled approximately 75,000 patients.

Key Points: 
  • DURHAM, N.C., Nov. 10, 2023 /PRNewswire/ -- Real-world evidence (RWE) leader Target RWE announced today that the CQC and TARGET-Liver Disease (LD) partnership with the American Association for the Study of Liver Diseases (AASLD) has enrolled approximately 75,000 patients.
  • Target RWE has enrolled approximately 75,000+ patients under the TARGET-LD protocol to support AASLD/CQC.
  • The strategic partnership between Target RWE and AASLD is designed to fulfill the unmet need for a large, real-world registry of patients with chronic liver diseases.
  • "These liver diseases are growing in prevalence and are placing a tremendous burden on healthcare systems around the world.

Top Gastroenterology and Liver Disease Specialist, Dr. David P. Yamini, Receives Castle Connolly's 2023 Top Doctor® Award

Retrieved on: 
Thursday, November 9, 2023
Hepatology, Irritable bowel syndrome, Disorder, American Gastroenterological Association, Stomach, Esophagus, ERCP, IBS, Liver, American College of Gastroenterology, Liver disease, Internal medicine, Indigestion, Patient, Multimedia, Gastrointestinal Endoscopy, Human, Santa Monica Boulevard, Castle Connolly Medical, Cedars-Sinai Medical Center, Pancreas, American College, Ulcerative colitis, Gallbladder, Crohn's disease, Gastroenterology, University, SIBO, Physician, Inflammatory bowel disease, Castle, Nursing, Film industry

BEVERLY HILLS, Calif., Nov. 9, 2023 /PRNewswire-PRWeb/ -- Dr. David Yamini has been selected as a 2023 Top Doctor® by Castle Connolly. Dr. Yamini is an accomplished physician who is double board-certified in gastroenterology and internal medicine. He serves patients in Santa Monica and Beverly Hills, CA, treating diseases and disorders of the digestive system. Dr. Yamini's medical education, training, hospital appointments and disciplinary history were rigorously screened by the Castle Connolly physician-led research team. Castle Connolly publishes its list of Top Doctors at http://www.castleconnolly.com and in a wide variety of partner publications, magazines and affiliate websites. Around 7% of the nation's top board-certified, licensed physicians have been selected as Castle Connolly Top Doctors in their regions for their specialties. Individuals do not and cannot pay to be selected as a Castle Connolly Top Doctor. Dr. David Yamini offers advanced diagnostic and therapeutic procedures and has established a reputation as one of the best Los Angeles gastroenterologists and liver disease specialists. Dr. Yamini offers expertise in issues involving the digestive tract, biliary system, liver and pancreas, with a proficiency in endoscopic retrograde cholangiopancreatography (ERCP). He takes a comprehensive approach to diagnosing and treating patients with all types of gastrointestinal (GI) problems and disorders that affect the small and large intestine, stomach, esophagus, gallbladder, liver and pancreas, including inflammatory bowel disease (Crohn's, ulcerative colitis), indigestion (dyspepsia), small intestinal bacterial overgrowth (SIBO) and irritable bowel syndrome (IBS). Dr. Yamini provides his patients with a superior level of compassionate and attentive personalized care.

Key Points: 
  • BEVERLY HILLS, Calif., Nov. 9, 2023 /PRNewswire-PRWeb/ -- Dr. David Yamini has been selected as a 2023 Top Doctor® by Castle Connolly.
  • Dr. Yamini's medical education, training, hospital appointments and disciplinary history were rigorously screened by the Castle Connolly physician-led research team.
  • Dr. David Yamini offers advanced diagnostic and therapeutic procedures and has established a reputation as one of the best Los Angeles gastroenterologists and liver disease specialists .
  • "It is such an honor to be recognized by my peers for this award," says Dr. David Yamini.

Omega Therapeutics Reports Third Quarter 2023 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Thursday, November 9, 2023
EGFR, Research, HCC, NSCLC, AACR, Rheumatism, American Association for the Study of Liver Diseases, OMEGA, IND, International, Therapy, Hepatology, Flagship Pioneering, Liver regeneration, G&A, Investigational New Drug, Conference, Palatine Nos. 1–8, 21, Fibrosis, Dive (Belgian band), MYC, Hepatitis, R, Pharmacokinetics, Acute respiratory distress syndrome, Omega, Epigenomics, Lung, Tissue, Annual report, Messenger, LNP, Institutional review board, Inflammation, Lung cancer, Hepatocellular carcinoma, Cancer, Patient, Gene expression, AASLD, Management, Pharmaceutical industry, Vaccine, Dietary supplement

As of September 30, 2023, the Company had cash, cash equivalents and marketable securities totaling $89.3 million.

Key Points: 
  • As of September 30, 2023, the Company had cash, cash equivalents and marketable securities totaling $89.3 million.
  • Research and development (R&D) expenses for the third quarter of 2023 were $16.5 million, compared to $20.7 million for the third quarter of 2022.
  • General and administrative (G&A) expenses for the third quarter of 2023 were $7.9 million, compared to $5.2 million for the third quarter of 2022.
  • Net loss for the third quarter of 2023 was $22.2 million, compared to $25.8 million for the third quarter of 2022, driven predominantly by a decrease in R&D expenses.

Assembly Biosciences Reports Third Quarter 2023 Financial Results and Recent Updates

Retrieved on: 
Wednesday, November 8, 2023
Research, IND, American Association for the Study of Liver Diseases, International, Infection, HSV, Therapy, Hepatology, Viral, Biotechnology, Liver, Viral hepatitis, Hepatitis D, Doctor of Philosophy, Gilead Sciences, Assembly, Partnership, Virology, Hepatitis B, Patient, HDV, HBV, AASLD, Pharmaceutical industry, Vaccine, Birth control, MD

Established partnership with Gilead Sciences to advance differentiated treatments for herpesviruses, HBV, HDV and beyond

Key Points: 
  • Established partnership with Gilead Sciences to advance differentiated treatments for herpesviruses, HBV, HDV and beyond
    SOUTH SAN FRANCISCO, Calif., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today reported financial results for the third quarter ended September 30, 2023, and recent corporate updates.
  • We believe that the financial and scientific resources provided by the collaboration position us well to reach critical short- and long-term milestones and deliver value for patients and our shareholders.
  • Partnership includes Gilead opt-in rights on Assembly Bio’s current and future pipeline candidates, including two contributed Gilead herpesvirus programs.
  • Cash, cash equivalents and marketable securities were $46.2 million as of September 30, 2023, compared to $59.8 million as of June 30, 2023.

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.

Precision BioSciences Announces Late-Breaking Poster Presentation at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting

Retrieved on: 
Thursday, November 9, 2023
Research, Infectious Diseases, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, Science, Oncology, Gene editing, Precision BioSciences, American Association for the Study of Liver Diseases, Hepatology, Conference, ID, Webcast, Annual general meeting, Conference call, Safety, AASLD, Vaccine, Broadcasting

Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene insertion, excision, and elimination, today announced that an abstract featuring preclinical data for its wholly owned PBGENE-HBV program has been accepted for late-breaker presentation at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting being held in Boston, MA on November 10-14, 2023.

Key Points: 
  • Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene insertion, excision, and elimination, today announced that an abstract featuring preclinical data for its wholly owned PBGENE-HBV program has been accepted for late-breaker presentation at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting being held in Boston, MA on November 10-14, 2023.
  • Title: Preclinical efficacy and safety of ARCUS-POL nucleases for chronic hepatitis B: a potentially curative strategy
    Company-Hosted Webcast and Conference Call Information:
    Precision will host a conference call and webcast on Monday, November 13, 2023 at 4:30 PM ET to discuss PBGENE-HBV program updates.
  • The dial-in conference call number is (800) 715-9871 and the conference ID number for the call is 3866428.
  • Participants may access the live webcast, and accompanying presentation materials, as well as the archived webcast on Precision’s website in the Investors section under Events & Presentations: https://investor.precisionbiosciences.com/events-and-presentations .

Alfasigma completes acquisition of Intercept Pharmaceuticals, Inc.

Retrieved on: 
Wednesday, November 8, 2023
Bezafibrate, Gastroenterology, Obeticholic acid, FDA, Delaware General Corporation Law, Food, Tax, Medication, Intercept Pharmaceuticals, Intercept, Liver, Acquisition, PBC, Primary biliary cholangitis, Autoimmune disease, USD, Hepatology, Patient, DNA, Food and Drug Administration, Holding company, Pharmaceutical industry, Pamlab

BOLOGNA, Italy and MORRISTOWN, N.J., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Alfasigma S.p.A. (“Alfasigma”) and Intercept Pharmaceuticals, Inc. (“Intercept”) announced today the completion of the acquisition of Intercept by Alfasigma through its wholly owned subsidiary Interstellar Acquisition Inc.

Key Points: 
  • BOLOGNA, Italy and MORRISTOWN, N.J., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Alfasigma S.p.A. (“Alfasigma”) and Intercept Pharmaceuticals, Inc. (“Intercept”) announced today the completion of the acquisition of Intercept by Alfasigma through its wholly owned subsidiary Interstellar Acquisition Inc.
  • As a result of the transaction, Intercept has become a wholly owned subsidiary of Alfasigma, and the common stock of Intercept has ceased to be traded on the NASDAQ Stock Market.
  • Stefano Golinelli, Chairman of Alfasigma, commented: “At Alfasigma, the passion we have for Pharmaceuticals is in our DNA - and a driver for our ambitious international growth plans.
  • Francesco Balestrieri, CEO of Alfasigma, added: “Today, we complete a transformational acquisition which strongly aligns with our strategy of building a solid presence in gastroenterology and hepatology, Alfasigma’s core business areas.