Hepatic encephalopathy

EnteroBiotix Completes £27m Financing Round to Advance Clinical Trials

Retrieved on: 
Thursday, April 4, 2024
Cirrhosis, Scottish Enterprise, Partnership, Patient, Irritable bowel syndrome, Bank, Standard of care, Therapy, Hepatic encephalopathy, Scottish National Investment Bank

GLASGOW, United Kingdom, April 04, 2024 (GLOBE NEWSWIRE) -- EnteroBiotix Limited, a clinical-stage biotechnology company focussed on developing best-in-class full-spectrum microbiome therapeutics, today announced that the Company has completed its £27m ($34m USD) funding round, supported by new and existing investors.

Key Points: 
  • GLASGOW, United Kingdom, April 04, 2024 (GLOBE NEWSWIRE) -- EnteroBiotix Limited, a clinical-stage biotechnology company focussed on developing best-in-class full-spectrum microbiome therapeutics, today announced that the Company has completed its £27m ($34m USD) funding round, supported by new and existing investors.
  • Existing investors including Scottish Enterprise and many of the Company’s private investors also participated.
  • Dr James McIlroy, CEO of EnteroBiotix, said: “This significant new investment helps enable our vision of transforming the standard of care for patients suffering from serious conditions linked to the gut microbiome.
  • It will help accelerate the development of our innovative product pipeline and propels us towards our goal of bringing these innovative treatments to market.

scPharmaceuticals Inc. Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, March 13, 2024
Research, Hypersensitivity, Glucose, Deafness, Congestion, Ascites, Furosemide, Cerebral edema, Growth, Edema, Kidney, Ototoxicity, Diuresis, Tinnitus, Bruise, New Drug Application, Patient, Coma, Oliguria, History, NYHA, NDA, Benign prostatic hyperplasia, IDN, Blood volume, Embolism, Insurance, Thrombosis, Trial of the century, Heart failure, Investment, CO2, Urine, Dehydration, Creatinine, Urinary retention, Erythema, Pharmacy, Chronic kidney disease, Organic acid, Patent, Hypoproteinemia, Internationalized domain name, BUN, Huber loss, FDA, Government, GTN, Cirrhosis, Hepatic encephalopathy, Azotemia, Uric acid, Anuria, Pharmaceutical industry

BURLINGTON, Mass., March 13, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced financial results for the fourth quarter and full-year ended December 31, 2023, and provided a business update. 

Key Points: 
  • Product revenues were $6.1 million, and cost of product revenues were $1.8 million for the fourth quarter of 2023.
  • Research and development expenses were $3.3 million for the fourth quarter of 2023, compared to $2.3 million for the fourth quarter of 2022.
  • Selling, general and administrative expenses were $16.2 million for the fourth quarter of 2023, compared to $7.2 million for the fourth quarter of 2022.
  • scPharmaceuticals reported a net loss of $13.8 million for the fourth quarter of 2023, compared to $9.2 million for the fourth quarter of 2022.

scPharmaceuticals Announces Preliminary Unaudited Q4 and Full-Year 2023 Net FUROSCIX® Revenue

Retrieved on: 
Thursday, January 4, 2024
Coma, Urine, Hepatic encephalopathy, Ascites, Kidney, Oliguria, Physician, Benign prostatic hyperplasia, Blood volume, Uric acid, Organic acid, Anuria, Urinary retention, NYHA, Furosemide, Cerebral edema, Hypersensitivity, Diuresis, Thrombosis, Deafness, Glucose, Azotemia, Ototoxicity, Creatinine, Tinnitus, Traction, BUN, Hypoproteinemia, Edema, Growth, Investment, Congestion, Huber loss, Patient, Bruise, Dehydration, CO2, Heart failure, Cirrhosis, Embolism, History, Erythema, Pharmaceutical industry

BURLINGTON, Mass., Jan. 04, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced preliminary unaudited fourth quarter 2023 net FUROSCIX revenue in a range of $5.9 million to $6.1 million, representing sequential growth of 55% to 61% over $3.8 million net FUROSCIX revenue reported for the third quarter of 2023.

Key Points: 
  • For the full year 2023, the Company anticipates net revenue to be in a range of $13.4 million to $13.6 million.
  • The gross-to-net discount decreased to approximately 18% from launch through the end of Q4 versus 21% from launch through the end of Q3.
  • Inventory levels at the end of Q4 2023 were consistent with levels at the end of Q3 2023.
  • scPharmaceuticals will report its final and complete fourth quarter and full-year 2023 financial results in March.

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.

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.

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.

scPharmaceuticals Inc. Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, November 8, 2023
NYHA, Cirrhosis, FDA, Research, Uric acid, Trial of the century, Deafness, Furosemide, Thrombosis, Erythema, Benign prostatic hyperplasia, Embolism, Internationalized domain name, Government, Hypoproteinemia, History, Kidney, Physician, Cerebral edema, Anuria, Bruise, Edema, Hepatic encephalopathy, Huber loss, Ototoxicity, Chronic kidney disease, Urinary retention, Congestion, Blood volume, Growth, Urine, Dehydration, Shanda, Diuresis, Pharmacy, Tinnitus, Medicaid, Azotemia, BUN, CO2, Oliguria, Organic acid, CKD, Investment, Patient, Creatinine, Heart failure, Hypersensitivity, Glucose, Coma, New York Heart Association Functional Classification, Ascites, Security (finance), Cryptocurrency, Pharmaceutical industry, Rare-earth element, Health insurance, Medical device, Video game, BURLINGTON

BURLINGTON, Mass., Nov. 08, 2023 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced financial results for the third quarter ended September 30, 2023, and provided a business update. 

Key Points: 
  • Product revenues were $3.8 million, and cost of product revenues were $1.1 million for the third quarter of 2023.
  • Research and development expenses were $3.4 million for the third quarter of 2023, compared to $3.7 million for the third quarter of 2022.
  • Selling, general and administrative expenses were $14.1 million for the third quarter of 2023, compared to $6.3 million for the third quarter of 2022.
  • As of September 30, 2023, scPharmaceuticals’ total shares outstanding was 35,859,045.
    scPharmaceuticals’ management will host a conference call and webcast to review the Company’s third quarter 2023 results today, Wednesday, November 8, at 4:30 p.m.

scPharmaceuticals Announces Positive Feedback from Two FDA Meetings on Key Long-Term Growth Initiatives

Retrieved on: 
Tuesday, September 19, 2023
Overload, Furosemide, PK, Hypersensitivity, NYHA, Congestion, Embolism, Hypoproteinemia, Organic acid, Heart failure, Hospital, Urine, Creatinine, Cirrhosis, Dehydration, Glucose, Tinnitus, Deafness, Huber loss, Edema, Hepatic encephalopathy, Oliguria, History, Solubility, Type, Diuresis, Uric acid, New York Heart Association Functional Classification, Kidney, Bruise, Shanda, Investigational New Drug, HIV disease progression rates, Patent, Patient, Physician, Ototoxicity, Urinary retention, Erythema, Azotemia, Ascites, Coma, Type D, Growth, Diagnosis, Blood volume, FDA, Benign prostatic hyperplasia, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CKD, Cerebral edema, CO2, Thrombosis, BUN, Food, Kidney disease, Anuria, Pharmaceutical industry

BURLINGTON, Mass., Sept. 19, 2023 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that the Company has received positive feedback from the U.S. Food and Drug Administration (FDA) on two key long-term growth initiatives.

Key Points: 
  • The Company also announced today feedback from a Type D meeting with the FDA pertaining to the potential expansion of the FUROSCIX label to include treatment of edema due to fluid overload in patients with CKD.
  • In its feedback, the FDA confirmed that no additional clinical studies are needed to expand the indication, provided that the Company demonstrates an adequate PK and pharmacodynamic bridge to the listed drug, furosemide injection, 10 mg/mL.
  • CKD is a progressive disease characterized by worsening renal function over time, resulting in frequent episodes of fluid overload that are treated with loop diuretics.
  • “We are very pleased to have reached alignment with the FDA on the advancement of these two very important long-term growth initiatives for our company,” stated John Tucker, Chief Executive Officer of scPharmaceuticals.

scPharmaceuticals Inc. Reports Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, August 10, 2023
Hypersensitivity, Furosemide, NYHA, Congestion, Embolism, Medicaid, Hypoproteinemia, Organic acid, Heart failure, Urine, Creatinine, Patient satisfaction, Cirrhosis, Dehydration, Tinnitus, Glucose, Deafness, Huber loss, Edema, Hepatic encephalopathy, Prescription, Research, Part, Oliguria, History, Government, Russell 3000 Index, Trial of the century, Diuresis, Uric acid, New York Heart Association Functional Classification, Kidney, Bruise, Ototoxicity, Erythema, Investment, Patient, Russell, Urinary retention, Cardiology, Azotemia, Ascites, Coma, Blood volume, FDA, Benign prostatic hyperplasia, Thrombosis, IND, Cerebral edema, CO2, BUN, Anuria, Security (finance), Cryptocurrency, Pharmaceutical industry, Health insurance, Medical device, Video game, BURLINGTON

BURLINGTON, Mass., Aug. 10, 2023 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced financial results for the second quarter ended June 30, 2023, and provided a business update. 

Key Points: 
  • For the second quarter ended June 30, 2023, scPharmaceuticals reports:
    Obtained national Medicaid coverage of FUROSCIX effective July 1, 2023.
  • Ended the second quarter of 2023 with cash, cash equivalents and short-term investments of $102.9 million.
  • Research and development expenses were $2.9 million for the second quarter of 2023, compared to $5.1 million for the second quarter of 2022.
  • Selling, general and administrative expenses were $12.1 million for the second quarter of 2023, compared to $4.3 million for the second quarter of 2022.

scPharmaceuticals Announces Positive Type C Meeting Feedback from FDA on Potential Heart Failure Class IV Indication Expansion

Retrieved on: 
Tuesday, August 1, 2023
Hypersensitivity, Furosemide, NYHA, Congestion, Embolism, US Foods, Hypoproteinemia, Organic acid, Heart failure, Chronic kidney disease, Urine, Creatinine, Cirrhosis, Dehydration, Glucose, Tinnitus, Deafness, Huber loss, Edema, Hepatic encephalopathy, Oliguria, History, Solubility, Diuresis, Uric acid, New York Heart Association Functional Classification, Kidney, Bruise, Ototoxicity, Erythema, Patent, Patient, Physician, Urinary retention, Azotemia, Ascites, Coma, Blood volume, FDA, Benign prostatic hyperplasia, Thrombosis, IND, Cerebral edema, CO2, BUN, Kidney disease, Anuria, Pharmaceutical industry, Medical device

FUROSCIX is currently indicated for the treatment of congestion due to fluid overload in adult patients with NYHA Class II and Class III chronic heart failure.

Key Points: 
  • FUROSCIX is currently indicated for the treatment of congestion due to fluid overload in adult patients with NYHA Class II and Class III chronic heart failure.
  • “We are very pleased with the outcome of our recent Type C meeting with the FDA, and believe this paves the way for potential expansion of the FUROSCIX indication to allow for use in NYHA Class IV patients,” stated John Tucker, Chief Executive Officer of scPharmaceuticals.
  • “We estimate that as many as 10% of all heart failure patients are Class IV, and a meaningful percentage of these – as many as 40% - may benefit from FUROSCIX.
  • FUROSCIX® is indicated for the treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure.