Hypertriglyceridemia

Arrowhead Pharmaceuticals Reports Fiscal 2024 Second Quarter Results

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목요일, 5월 9, 2024
Biotechnology, Pharmaceutical, Genetics, Health, Molecule, PALISADE, EAP, American College, FCS, Risk, PIN, Hypertriglyceridemia, Arrowhead, APOC3, RNA, Webcast, Triglyceride, Cardiology, Patient, Cardiovascular disease, Diagnosis, Clinical trial, JAMA Cardiology, Amgen, Pharmaceutical industry

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its fiscal 2024 second quarter ended March 31, 2024.

Key Points: 
  • Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its fiscal 2024 second quarter ended March 31, 2024.
  • The Company is hosting a conference call today, May 9, 2024, at 4:30 p.m.
  • Received a $50 million milestone payment from Royalty Pharma plc, which was paid in the third quarter of fiscal 2024, following the completion of enrollment of the Phase 3 OCEAN(a) - Outcomes Trial of olpasiran, being conducted by Amgen.
  • Each event will feature presentations by Arrowhead team members and external key opinion leaders, who will discuss the respective disease areas and treatment landscapes.

89bio Reports First Quarter 2024 Financial Results and Provides Corporate Update

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목요일, 5월 9, 2024
MASH, University, Patient, Cirrhosis, Research and development, Liver disease, EASL, Safety, Hypertriglyceridemia, Administration, Journal of Clinical Pathology, Hepatology, Virginia Commonwealth University, PRIME, European Medicines Agency, Liver, Enrollment, EMA, Fibrosis, Division, SAN, Pharmaceutical industry

SAN FRANCISCO, May 09, 2024 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today reported its financial results for the first quarter ended March 31, 2024.

Key Points: 
  • SAN FRANCISCO, May 09, 2024 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today reported its financial results for the first quarter ended March 31, 2024.
  • These key clinical developments, coupled with our agreement for commercial supply, are designed to strategically enhance our readiness for potential commercialization."
  • ENLIGHTEN-Cirrhosis, the second trial in the program, is planned to evaluate patients with compensated cirrhosis and is expected to initiate in the second quarter of 2024.
  • As of March 31, 2024, 89bio had cash, cash equivalents and marketable securities of approximately $562.3 million.

Mammoth Biosciences to Present at Annual Meeting of the American Society of Gene & Cell Therapy

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목요일, 5월 2, 2024
Science, Stem Cells, Other Science, Biotechnology, Research, Health, Genetics, Clinical Trials, CRISPR, Tissue, Hypertriglyceridemia, Cell, Liver, Patient, Gene, Society, NHP, Annual general meeting, Mammoth Biosciences, Vaccine

Mammoth Biosciences , a biotechnology company harnessing its proprietary next-generation CRISPR gene-editing platform to create potential one-time curative therapies, today announced that Lucas Harrington, Ph.D., Mammoth’s co-founder and Chief Scientific Officer, will present new preclinical data at the American Society of Gene & Cell Therapy (ASGCT) 27th Annual Meeting in Baltimore, May 7 - 11, 2024.

Key Points: 
  • Mammoth Biosciences , a biotechnology company harnessing its proprietary next-generation CRISPR gene-editing platform to create potential one-time curative therapies, today announced that Lucas Harrington, Ph.D., Mammoth’s co-founder and Chief Scientific Officer, will present new preclinical data at the American Society of Gene & Cell Therapy (ASGCT) 27th Annual Meeting in Baltimore, May 7 - 11, 2024.
  • The oral presentation will describe the optimization of Mammoth’s novel ultracompact CRISPR platform, and its performance in targeting the APOC3 gene, a primary genetic driver of triglyceride metabolism, in humanized mouse models and non-human primates.
  • “Our findings demonstrate the potential of Mammoth’s ultracompact CRISPR systems to deliver in vivo therapies in the liver, beginning with our lead program targeting APOC3, a key factor in familial chylomicronemia syndrome and severe hypertriglyceridemia,” Dr. Harrington said.
  • “We look forward to sharing these data with the scientific community at ASGCT, and to providing future updates as we continue to develop our novel ultracompact nucleases and associated gene-editing technologies to better target tissues beyond the liver and to positively impact the lives of patients living with genetic disease.”
    Title: Reduction in Triglycerides through a Novel Ultracompact CRISPR System: Efficacy in Mouse Models and NHP Studies
    Additionally, Janice Chen, Ph.D., co-founder and Chief Technology Officer of Mammoth, and incoming chair of the ASGCT Genome Editing Committee, will co-chair the following scientific symposium:

Arrowhead Pharmaceuticals Announces New Phase 2 Data of Plozasiran Published in JAMA Cardiology and Presented at American College of Cardiology 73rd Annual Scientific Session & Expo

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일요일, 4월 7, 2024
Science, Cardiology, Biotechnology, Research, Pharmaceutical, Health, FDA, Clinical Trials, Arrowhead, Principal, Urinary tract infection, JAMA Cardiology, Apolipoprotein C-III, Risk, Headache, Patient, Hypertriglyceridemia, Diarrhea, COVID-19, American College, APOC3, Pancreatitis, Safety, Pharmaceutical industry

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today presented final data from the double-blind treatment period of its Phase 2 SHASTA-2 study of investigational plozasiran (formerly ARO-APOC3) in patients with severe hypertriglyceridemia (SHTG).

Key Points: 
  • Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today presented final data from the double-blind treatment period of its Phase 2 SHASTA-2 study of investigational plozasiran (formerly ARO-APOC3) in patients with severe hypertriglyceridemia (SHTG).
  • Results from the SHASTA-2 study showed dramatic, consistent, and sustained reductions in Apolipoprotein C-III (APOC3) and triglycerides and improvement in multiple atherogenic lipoprotein levels.
  • These data were presented in a late-breaking oral presentation today at the American College of Cardiology 73rd Annual Scientific Session & Expo (ACC.24) in Atlanta and simultaneously published in the journal JAMA Cardiology .
  • Subjects treated with plozasiran also showed improvements in multiple atherogenic lipid and lipoprotein levels, including remnant cholesterol, HDL-cholesterol, and non-HDL cholesterol.

Arrowhead Pharmaceuticals Initiates Expanded Access Program for Plozasiran and Announces Upcoming Presentation of Clinical Data

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월요일, 3월 25, 2024
Infectious Diseases, Diabetes, Genetics, Clinical Trials, Cardiology, Biotechnology, Health, Pharmaceutical, Oncology, Arrowhead, Diagnosis, PALISADE, Patient, Hypertriglyceridemia, EAP, Science, Microsoft Access, American College, Clinical trial, RNA interference, FCS, Therapy, Physician, Pharmaceutical industry

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has initiated an Expanded Access Program (EAP) to make investigational plozasiran available outside of a clinical trial for patients with familial chylomicronemia syndrome (FCS) who meet certain program eligibility criteria.

Key Points: 
  • Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has initiated an Expanded Access Program (EAP) to make investigational plozasiran available outside of a clinical trial for patients with familial chylomicronemia syndrome (FCS) who meet certain program eligibility criteria.
  • Arrowhead will also present new final Phase 2 clinical data from the double-blind portion of the SHASTA-2 study of plozasiran in a late-breaking oral presentation at the upcoming American College of Cardiology 73rd Annual Scientific Session & Expo (ACC.24), being held in Atlanta on April 6-8, 2024.
  • “Arrowhead is committed to supporting patients living with various lipid disorders and the physicians who treat them.
  • “Our Phase 3 PALISADE study of plozasiran in patients with FCS is nearing completion and we are further supporting the patient community by initiating an expanded access program for patients and physicians interested in receiving treatment with plozasiran outside of a clinical trial.

CRISPR Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results

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수요일, 2월 21, 2024
Sale, CD19, Lupus, RNA, EAP, LNP, Liver, Cardiovascular disease, CRISPR Therapeutics, CRSP, Therapy, Vertex Pharmaceuticals, Sickle cell disease, Autoimmunity, T1D, G&A, Bill, Partnership, Pharmacology, Guide, SCD, TDT, Pharmacokinetics, Clinical trial, ANGPTL3, United, Hypertriglyceridemia, Medicaid, Research, Human, CRISPR, Gene editing, CD70, Stem cell, ADC, Risk, Genetics, Patient, SLE, KSA, Moyamoya disease, Pharmaceutical industry

R&D Expenses: R&D expenses were $95.1 million for the fourth quarter of 2023, compared to $103.6 million for the fourth quarter of 2022.

Key Points: 
  • R&D Expenses: R&D expenses were $95.1 million for the fourth quarter of 2023, compared to $103.6 million for the fourth quarter of 2022.
  • G&A Expenses: General and administrative expenses were $16.5 million for the fourth quarter of 2023, compared to $21.2 million for the fourth quarter of 2022.
  • Collaboration Expense: Collaboration expense, net, was $20.0 million for the fourth quarter of 2023, compared to $6.8 million for the fourth quarter of 2022.
  • Net Income (Loss): Net income was $89.3 million for the fourth quarter of 2023, compared to a net loss of $110.6 million for the fourth quarter of 2022.

CRISPR Therapeutics Highlights Strategic Priorities and 2024 Outlook

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월요일, 1월 8, 2024
LNP, Liver, Gene editing, Risk, Autoimmunity, Moyamoya disease, FDA, CRSP, SLE, Lupus, Stem cell, ANGPTL3, Pharmacology, CHMP, Kingdom, Guide, CRISPR Therapeutics, Vertex, PDUFA, Human, Pharmacokinetics, RNA, EMA, CRISPR, Therapy, Genetics, Vertex Pharmaceuticals, Bill, Patient, CD70, SCD, T1D, Sickle cell disease, Partnership, Hypertriglyceridemia, Research, Insulin, Diabetes, Hospital, Clinical trial, GMP, European Medicines Agency, Growth, Committee, CD19, TDT, Cardiovascular disease, Good, ADC, Pharmaceutical industry

ZUG, Switzerland and BOSTON, Jan. 08, 2024 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, today highlighted its strategic priorities and 2024 outlook as the Company enters its next phase of growth.

Key Points: 
  • ZUG, Switzerland and BOSTON, Jan. 08, 2024 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, today highlighted its strategic priorities and 2024 outlook as the Company enters its next phase of growth.
  • Exa-cel is the first therapy to emerge from a strategic partnership between CRISPR Therapeutics and Vertex Pharmaceuticals.
  • Vertex leads global development, manufacturing, regulatory and commercialization of CASGEVY with support from CRISPR Therapeutics.
  • CRISPR Therapeutics continues to focus on resource efficiency and return on invested capital as it advances multiple clinical programs across its pipeline.

Human medicines European public assessment report (EPAR): Jakavi, ruxolitinib, Date of authorisation: 23/08/2012, Revision: 29, Status: Authorised

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화요일, 1월 2, 2024
Janus, Liver, Marketing, PV, INN, Hypertension, Graft-versus-host disease, Polycythemia, Hydroxycarbamide, Infection, Transplant, Splenomegaly, Bruise, Polycythemia vera, Bacteria, Anatomy, IIA, Spleen, Fever, Hypercholesterolemia, Primary myelofibrosis, ATC, Bleeding, Disease, Ageing, JAK, Neutrophil, Blood, System, Disorder, Weight gain, Enzyme, Safety, Anemia, Sepsis, Medical Subject Headings, Agency, B cell, International, Bone pain, Neutropenia, Language, Mouth, Dizziness, Thrombocytopenia, Pancreatic serous cystadenoma, Hypertriglyceridemia, Tablet, Select, Patient, Medicine, Phlebotomy, Hormone, Woman, Weight loss, Headache, Cytomegalovirus, European Medicines Agency, Growth, Janus kinase, Urinary tract infection, Medical device

Human medicines European public assessment report (EPAR): Jakavi, ruxolitinib, Date of authorisation: 23/08/2012, Revision: 29, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Jakavi, ruxolitinib, Date of authorisation: 23/08/2012, Revision: 29, Status: Authorised

Amneal Expands Portfolio with Addition of Icosapent Ethyl Acid Soft Gel Capsules

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금요일, 12월 1, 2023
FDA, Health, General Health, Research, Pharmaceutical, Science, Diet, DSM-IV codes, EPA, NYSE, Business development, Organization, 1G, Constipation, Patient, Atrial fibrillation, Peripheral edema, Partnership, Eicosapentaenoic acid, Medication, Gout, Hypertriglyceridemia, Stride, Ethyl eicosapentaenoic acid

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) and Strides Pharma Science Limited (“Strides”) today announced the addition of Icosapent ethyl acid soft gel capsules, a product referencing VASCEPA®.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) and Strides Pharma Science Limited (“Strides”) today announced the addition of Icosapent ethyl acid soft gel capsules, a product referencing VASCEPA®.
  • The product has been in-licensed from Strides, a global pharmaceutical manufacturer, and will be commercialized by Amneal starting in the fourth quarter of 2023.
  • Icosapent ethyl acid soft gel capsules 0.5g and 1g is an ethyl ester of eicosapentaenoic acid (EPA) that is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
  • “The launch of Icosapent ethyl is another essential medicine that we’ve added to our portfolio.”
    “We are thrilled to announce our partnership with Amneal Pharmaceuticals for Icosapent ethyl acid soft gelatin capsules.

Arrowhead Pharmaceuticals Reports Fiscal 2023 Year End Results

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수요일, 11월 29, 2023
Oncology, Health, Genetics, General Health, Pharmaceutical, Cardiology, Biotechnology, Webcast, Hypertriglyceridemia, GLP, Johnson & Johnson, Janssen Pharmaceuticals, Toxicology, International, RNA interference, Heart, AHA, GSK plc, Cholesterol, PIN, ERS, Patient, Cleveland Clinic, European Respiratory Society, Idiopathic pulmonary fibrosis, American Heart Association, GSK, MD, Janssen, Doctor of Philosophy, ANGPTL3, Triglyceride, Pharmaceutical industry, Medical device, Arrowhead, Medicine, APOC3

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its fiscal year ended September 30, 2023.

Key Points: 
  • Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its fiscal year ended September 30, 2023.
  • The company is hosting a conference call today, November 29, 2023, at 4:30 p.m.
  • ET to discuss the results.
  • JNJ-3989 (formerly ARO-HBV) was initially in-licensed by Janssen from Arrowhead in 2018