ACLF

GENFIT Reports Full-Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, April 4, 2024
MAA, ACLF, Primary biliary cholangitis, Patient, Research, Ipsen, Placebo, EMA, Bank statement, Marketing, PBC, FDA, EF, Pharmaceutical industry

“A remarkable milestone was reached by GENFIT in 2023 with the announcement of positive topline data for our Phase 3 ELATIVE® trial evaluating elafibranor in Primary Biliary Cholangitis.

Key Points: 
  • “A remarkable milestone was reached by GENFIT in 2023 with the announcement of positive topline data for our Phase 3 ELATIVE® trial evaluating elafibranor in Primary Biliary Cholangitis.
  • This was followed by another asset acquisition in July 2023, where GENFIT licensed the exclusive worldwide rights of CLM-022, a potential first-in-class inflammasome inhibitor, from Celloram.
  • IND was in effect as of April 17, 2023 and the first patient was randomized in the UNVEIL-IT® Phase 2 trial in July 2023.
  • GENFIT equally obtained a “Prime status” label by ISS ESG, upgrading its corporate rating from C to C+.

Mallinckrodt Presents New Data on TERLIVAZ® (terlipressin) for Injection at the Society of Critical Care Medicine (SCCM) 2024 Critical Care Congress

Retrieved on: 
Monday, January 22, 2024
Hypoxia, Patient, Alcoholic hepatitis, Cirrhosis, ACLF, Respiratory failure, Society, Risk, Critical care, Mallinckrodt, Oxygen saturation (medicine), Congress, Boxed warning, Critical Care Medicine (journal), Clinical trial, Volume overload, HRS, SCCM, Use, SCR, Dietary supplement

DUBLIN, Jan. 22, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced the presentation of findings from a post hoc analysis of the Phase 3 CONFIRM clinical trial. In this analysis, treatment with TERLIVAZ® (terlipressin) for injection was associated with improvements in verified hepatorenal syndrome (HRS) reversal and HRS reversal vs. placebo in adult cirrhosis patients with alcoholic hepatitis (AH) and HRS with rapid reduction in kidney function.1,2 The results will be shared in an oral presentation at the Society of Critical Care Medicine (SCCM) 2024 Critical Care Congress, taking place January 21-23, 2024, in Phoenix, AZ.

Key Points: 
  • Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk.
  • Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO2 decreases below 90%.
  • Ineligibility for Liver Transplant: TERLIVAZ-related adverse reactions (respiratory failure, ischemia) may make a patient ineligible for liver transplantation, if listed.
  • For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks.

GENFIT Updates 2024 Outlook Following Acceptance of Elafibranor Filings in Primary Biliary Cholangitis (PBC)

Retrieved on: 
Friday, December 8, 2023
Hepatic encephalopathy, Ipsen, AASLD, Cell death, Food, Itch, Priority review, Food and Drug Administration, PSC, IND, ACLF, Marketing, FDA, EMA, MAA, PDUFA, Permeability (electromagnetism), Liver, NDA, Inflammation, Primary sclerosing cholangitis, ALP, Capital market, Hyperammonemia, Patient, NTZ, Fibrosis, PBC, ASK1

Launches in the US and Europe will also make GENFIT eligible for royalty payments.

Key Points: 
  • Launches in the US and Europe will also make GENFIT eligible for royalty payments.
  • Revenues will fund the development of GENFIT’s pipeline, now mainly focused on Acute On-Chronic Liver Failure (ACLF) with 5 differentiated assets.
  • Acceptance of filings in the US and Europe have triggered the first milestone payment for GENFIT.
  • Ipsen also indicated that it is developing elafibranor in Primary Sclerosing Cholangitis (PSC) which could lead to further revenues for GENFIT under the licensing agreement.

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.

GENFIT Highlights ACLF Development Strategy at “ACLF Day” during AASLD The Liver Meeting® 2023

Retrieved on: 
Thursday, November 16, 2023
Multiple organ dysfunction syndrome, Primary biliary cholangitis, Permeability (electromagnetism), Hepatic encephalopathy, PBC, AASLD, IND, Disease, Mortality, Cirrhosis, Elafibranor, UCSF, Patient, Heart, Liver, ASK1, Caregiver, NTZ, Chronic liver disease, Cell death, MBA, MD, University, Transplant, Doctor of Philosophy, Microbiota, Fibrosis, Ipsen, University of California, European Foundation, Human, Inflammation, Pharmaceutical industry, ACLF, Hyperammonemia, Boston, Euronext

GENFIT is now mainly focused on the development of therapies for ACLF which is an area of very high unmet medical need.

Key Points: 
  • GENFIT is now mainly focused on the development of therapies for ACLF which is an area of very high unmet medical need.
  • ACLF is a potentially deadly, but reversible, condition in patients with chronic liver diseases, which is associated with multi-organ failure and high short-term mortality.
  • Pascal Prigent, CEO of GENFIT, commented: “During AASLD we were excited to further discuss our development strategy around our new pipeline focused on ACLF, where we believe multiple programs have the potential to transform the treatment paradigm for these patients.
  • As part of the “ACLF Day” event during AASLD, the critical need for treatment has been highlighted by leading experts in ACLF.

GENFIT Reports Third Quarter 2023 Financial Information

Retrieved on: 
Thursday, November 9, 2023
Research, ACLF, PBC, Patient, Part, Collaboration, NTZ, Primary biliary cholangitis, Cryptocurrency, Pharmaceutical industry, Euronext, Ipsen

As of September 30, 2023, the Company’s cash and cash equivalents amounted to €93.9 million compared with €163.6 million a year earlier.

Key Points: 
  • As of September 30, 2023, the Company’s cash and cash equivalents amounted to €93.9 million compared with €163.6 million a year earlier.
  • As of June 30, 2023, cash and cash equivalents totaled €111.8 million.
  • We expect that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements until approximately the fourth quarter of 2024.
  • Revenue2 for the first nine months of 2023 amounted to €14.3 million compared to €14.1 million for the same period in 2022.

Mallinckrodt to Present Breadth of Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the American Association for the Study of Liver Diseases (AASLD) 2023 Liver Meeting

Retrieved on: 
Wednesday, November 8, 2023
Patient, Medical Affairs Bureau, Cohort (statistics), Respiratory failure, Oxygen saturation (medicine), Boxed warning, Use, Physician, MD, Blood, Kidney, Research, ACLF, Hepatorenal syndrome, American Association for the Study of Liver Diseases, Database, Risk, Volume overload, Safety, HRS, Abstract, Hypoxia, AASLD, Pharmaceutical industry, Dietary supplement, Nursing, Mallinckrodt, Hepatology

DUBLIN, Nov. 8, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, today announced the presentation of 11 scientific abstracts with findings from the latest clinical and health economics research with TERLIVAZ® (terlipressin) for injection for adult patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 during the American Association for the Study of Liver Diseases (AASLD) 2023 Liver Meeting, taking place November 10-14, 2023 in Boston, MA.

Key Points: 
  • Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/9111651-mallinckrodt-aasld-2023-...
    Please see Limitation of Use and Important Safety Information, including Boxed Warning, below.
  • Data collected in retrospective, pooled, database, or post hoc analyses may have errors or omissions.
  • Outcomes may be influenced by therapies not evaluated in the study and the clinical/health economic outcomes may not be solely attributable to TERLIVAZ.
  • TERLIVAZ® is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.

GENFIT to Present Update on Scientific and Corporate Progress at The Liver Meeting® 2023

Retrieved on: 
Thursday, November 2, 2023
Transplant, Labcorp, UCSF, American Association for the Study of Liver Diseases, BMI, Hepatology, MD, University of California, MBA, ACLF, PBC, Gubra, NAS, Poster, Division, NASH, GAN, Biopsy, University, CET, Primary biliary cholangitis, FACP, Ipsen, Patient, Abstract, Liver support system, IQVIA, AASLD, Medical device, Pharmaceutical industry, Medical imaging, Euronext, Gastroenterology

Participants include study investigators, principal investigators and other healthcare professionals from the US, France, Germany and the UK.

Key Points: 
  • Participants include study investigators, principal investigators and other healthcare professionals from the US, France, Germany and the UK.
  • Two Patient Advocacy Council sessions will be held on Saturday November 11, 2023.
  • Participants in this event include Dr. Jennifer Lai (MD, MBA, FACP) and the Global Liver Institute.
  • GENFIT will present new data on its NASH diagnostics technology, including:
    The impact of BMI on NIS2+™ and established non-invasive tests for the evaluation of non-alcoholic liver disease (15’ Oral Presentation #238, Pr.

Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the American Society of Nephrology (ASN) Kidney Week 2023 Scientific Meeting

Retrieved on: 
Wednesday, November 1, 2023
Patient, Comorbidity, Incidence, Respiratory failure, Alcoholic hepatitis, Oxygen saturation (medicine), Boxed warning, Use, Renal replacement therapy, Blood, Health, Kidney, ACLF, Society, American Society of Nephrology, Hepatorenal syndrome, Phase, ASN, Risk, Volume overload, HRS, Hypoxia, Pharmaceutical industry, Dietary supplement, Mallinckrodt, MD

DUBLIN, Nov. 1, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, today announced that three scientific abstracts evaluating treatment with TERLIVAZ® (terlipressin) for injection for adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 – including its impact on patient care, key HRS endpoints and patient comorbidity – will be presented at the American Society of Nephrology (ASN) Kidney Week 2023 Scientific Meeting in Philadelphia, Pennsylvania, taking place November 2-5, 2023.

Key Points: 
  • "1
    These studies are sponsored by Mallinckrodt Pharmaceuticals and include:
    TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
  • Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk.
  • Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO2 decreases below 90%.
  • For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks.

Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the American College of Gastroenterology (ACG) Annual Scientific Meeting

Retrieved on: 
Sunday, October 22, 2023
Gastroenterology, FDA, Comorbidity, Hepatorenal syndrome, American College, Respiratory failure, PDT, EDT, Heart rate, Boxed warning, Oxygen saturation (medicine), Use, DBP, Physician, ACG, Cirrhosis, Mortality, Effect, Treatment, Post hoc analysis, MAP, SBP, Acute kidney injury, American College of Gastroenterology, Research, ACLF, Baylor University Medical Center, Phase, White, Chronic liver disease, Risk, Hospital, Maryland School, Volume overload, University, Stanford University School of Medicine, CLD, Blood pressure, HRS, Hypoxia, Pharmaceutical industry, Dietary supplement, Medical device, Nursing, Communications satellite, Mallinckrodt, Patient, MD, Terlipressin

DUBLIN, Oct. 22, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, today announced that three posters detailing findings from Mallinckrodt's latest clinical and health economics outcomes research with TERLIVAZ® (terlipressin) for injection for adult patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function1,2,3,4 will be presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Vancouver, British Columbia, taking place October 20-25, 2023.

Key Points: 
  • Outcomes may be influenced by therapies not evaluated in the study and the clinical/health economic outcomes may not be solely attributable to TERLIVAZ.
  • TERLIVAZ® is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
  • For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks.
  • If TERLIVAZ is used during pregnancy, the patient should be informed of the potential risk to the fetus.