HDV

Bluejay Therapeutics Receives Positive Opinion on Orphan Designation from the European Medicines Agency for BJT-778 for the Treatment of Chronic Hepatitis D

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水曜日, 5月 29, 2024
European Medicines Agency, Conditional sentence, Patient, Therapy, EMA, HDV, Hepatology, SAN, CHD, Pharmaceutical industry

SAN MATEO, Calif., May 29, 2024 (GLOBE NEWSWIRE) -- Bluejay Therapeutics, a private clinical-stage biopharmaceutical company focused on viral and liver diseases with unmet medical needs, today announced that the European Medicines Agency (EMA) has issued a positive opinion on the Company’s application for orphan designation for BJT-778 for the treatment of chronic hepatitis D (CHD).

Key Points: 
  • SAN MATEO, Calif., May 29, 2024 (GLOBE NEWSWIRE) -- Bluejay Therapeutics, a private clinical-stage biopharmaceutical company focused on viral and liver diseases with unmet medical needs, today announced that the European Medicines Agency (EMA) has issued a positive opinion on the Company’s application for orphan designation for BJT-778 for the treatment of chronic hepatitis D (CHD).
  • “We are delighted that the EMA has issued a positive opinion for orphan designation for BJT-778.
  • This recognition underscores the urgent need for new treatment options for people living with this devastating chronic infection,” said Keting Chu, Founder and CEO of Bluejay Therapeutics.
  • “We are eager to accelerate the development of BJT-778 and make it available to patients as soon as possible.

Bluejay Therapeutics Announces Upcoming Presentations at the European Association for the Study of the Liver (EASL) Congress 2024

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水曜日, 5月 22, 2024
HBsAg, Pharmacokinetics, Hepatitis B, CHD, EASL, University, Therapy, Safety, SAN, HBV, Blue jay, Abstract, HDV, Auckland City Hospital, Vaccine

SAN MATEO, Calif., May 22, 2024 (GLOBE NEWSWIRE) -- Bluejay Therapeutics today announced it will present new data from its ongoing Phase 2 trial evaluating the potential of BJT-778, an investigational anti-HBsAg monoclonal antibody (mAb) that acts against hepatitis B surface antigen, for the treatment of chronic hepatitis D (CHD) at the European Association for the Study of the Liver (EASL) conference taking place June 5-8, in Milan, Italy.

Key Points: 
  • SAN MATEO, Calif., May 22, 2024 (GLOBE NEWSWIRE) -- Bluejay Therapeutics today announced it will present new data from its ongoing Phase 2 trial evaluating the potential of BJT-778, an investigational anti-HBsAg monoclonal antibody (mAb) that acts against hepatitis B surface antigen, for the treatment of chronic hepatitis D (CHD) at the European Association for the Study of the Liver (EASL) conference taking place June 5-8, in Milan, Italy.
  • Bluejay will also present several posters describing the preclinical profile of BJT-778, its mechanisms of action, and its pharmacokinetics and safety profile in healthy volunteers.
  • Four abstracts have been selected for presentation, including a late-breaker poster presentation that will highlight the safety, tolerability, and antiviral activity data from the Phase 2 trial evaluating BJT-778 for the treatment of chronic hepatitis delta virus (HDV).
  • Additional presentations will focus on the safety and pharmacokinetic profile of BJT-778 in healthy volunteers, the preclinical profile of BJT-778, including its affinity against HBsAg, neutralizing activity against hepatitis B and D viruses, and its pan-genotypic activity, and BJT-778’s preclinical immunomodulatory activity, showcasing its potential for enhancing antiviral T cells functions to potentially clear HBV infection.

Assembly Biosciences to Present Data at Upcoming International Herpesvirus Workshop and EASL Congress™ 2024

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水曜日, 5月 22, 2024
Doctor of Philosophy, EASL, Treatment, Genital herpes, Viral, Poster, Safety, SAN, Assembly, Gilead Sciences, HSV, HDV, Cirrhosis, Hepatitis D, Viral hepatitis, Injection, Abstract, Therapy, Biotechnology, Standard of care, Vaccine

SOUTH SAN FRANCISCO, Calif., May 22, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced that the company will present data from its herpes simplex virus (HSV) and hepatitis D virus (HDV) pipeline programs at upcoming medical congresses. Assembly Bio’s abstracts for ABI-5366 and ABI-1179 have been accepted for one oral and two poster presentations at the International Herpesvirus Workshop, taking place in Portland, Ore., July 13-17, 2024. An abstract for ABI-6250 has been accepted for poster presentation at the European Association for the Study of the Liver (EASL) Congress™ 2024 taking place in Milan, Italy, June 5-8, 2024.

Key Points: 
  • Assembly Bio’s abstracts for ABI-5366 and ABI-1179 have been accepted for one oral and two poster presentations at the International Herpesvirus Workshop, taking place in Portland, Ore., July 13-17, 2024.
  • An abstract for ABI-6250 has been accepted for poster presentation at the European Association for the Study of the Liver (EASL) Congress™ 2024 taking place in Milan, Italy, June 5-8, 2024.
  • At the International Herpesvirus Workshop, Assembly Bio will present data describing the preclinical profile of ABI-5366, a long-acting helicase-primase inhibitor candidate in development for the treatment of recurrent genital herpes.
  • “We’re excited to present data from both of these potent, long-acting HSV helicase-primase inhibitors at the International Herpesvirus Workshop,” said William Delaney, PhD, chief scientific officer of Assembly Bio.

Gilead to Present Latest Research Across Key Liver Disease Indications at the European Association for the Study of the Liver Congress 2024

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水曜日, 5月 22, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, Infectious Diseases, Hospitals, Clinical Trials, Hepatitis C, Risk, Medicaid, FDA, Senior, PBC, Congress, HDV, Itch, HCV, Woman, Cirrhosis, Abstract (summary), Bulevirtide, European Economic Area, Hepatitis, Liver disease, Ascending cholangitis, HBV, MD, Civil service commission, European Commission, Primary biliary cholangitis, Ursodeoxycholic acid, Gross metropolitan product, Food, Education, Disease, Safety, Gilead Sciences, ULN, Incidence, Policy, Alkaline phosphatase, Viral hepatitis, WHO, Liver cancer, Liver failure, Patient, EASL, Diagnosis, Abstract, UDCA, Fatigue, Quality of life, ALP, Pharmaceutical industry

Gilead Sciences, Inc. (Nasdaq:GILD) today announced new research to be presented at the European Association for the Study of the Liver (EASL) Congress, June 5-8, 2024 in Milan, Italy.

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq:GILD) today announced new research to be presented at the European Association for the Study of the Liver (EASL) Congress, June 5-8, 2024 in Milan, Italy.
  • “These data underline Gilead’s commitment to drive life-changing science and create healthier futures for people living with liver disease.
  • “The breadth of our data being presented across viral and inflammatory liver diseases, speaks to our commitment to driving positive change at every step of a person’s journey.
  • Further highlighting Gilead as a leader in HDV research, a sub-analysis of the MYR204 study (OS-122) evaluating intrahepatic virological outcomes 24 Weeks off-treatment will be presented.

Bluejay Therapeutics Secures $182 Million in Series C Financing to Propel Clinical Pipeline

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木曜日, 5月 9, 2024
T. Rowe Price, HBM, HDV, New Board, Therapy, EMA, General partnership, Wellington Management Company, Series, SAN, Global health

SAN MATEO, Calif., May 09, 2024 (GLOBE NEWSWIRE) -- Bluejay Therapeutics, a leader in the development of novel therapeutics, today announced the successful closure of a $182 million Series C financing round.

Key Points: 
  • SAN MATEO, Calif., May 09, 2024 (GLOBE NEWSWIRE) -- Bluejay Therapeutics, a leader in the development of novel therapeutics, today announced the successful closure of a $182 million Series C financing round.
  • This capital infusion will accelerate the clinical development of BJT-778, as the treatment for chronic hepatitis D (HDV).
  • The funds will also support the progression of additional promising candidates in Bluejay's robust pipeline for the treatment for chronic hepatitis B.
  • Following the completion of the Series C financing, Bluejay is excited to welcome New Board Member, Daniel Estes, a General Partner at Frazier, to its Board of Directors.

Assembly Biosciences Reports First Quarter 2024 Financial Results and Recent Highlights

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水曜日, 5月 8, 2024
Assembly, EASL, HDV, Gilead Sciences, Safety, Viral, Simplex, Research, HSV, Therapy, Clinical trial, Biotechnology, HBV

“These clearances are a significant step toward our goal of reaching key clinical inflection points for multiple programs in our antiviral pipeline by year end.

Key Points: 
  • “These clearances are a significant step toward our goal of reaching key clinical inflection points for multiple programs in our antiviral pipeline by year end.
  • Assembly Bio’s cash position is projected to fund operations into the second half of 2025.
  • Revenues from collaborative research were $5.8 million for the three months ended March 31, 2024.
  • Revenue for the three months ended March 31, 2024 consists of amounts recognized under the collaboration with Gilead.

Current Affairs: The Trends Shaping EV Charging Technology, Reports IDTechEx

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木曜日, 4月 18, 2024
Hydrogen, MCS, HDV, Toyota, Volvo, BEV, Traction, Electricity, Research, Watt, CCS, CONFIG.SYS, EV, Fleet, Hitachi, GM, Electric vehicle, AC, Daimler, Government, Growth, Players

BOSTON, April 18, 2024 /PRNewswire/ -- Based on their ongoing research into the EV charging market, IDTechEx estimates that 222 million chargers will be needed by 2034 to support the growing global EV fleet. IDTechEx also predicts that the cumulative global investment in global charging infrastructure will exceed $123 billion by 2034 (hardware cost alone). IDTechEx research aims to keep up with the changes and developments in EV charging by monitoring and analyzing the EV charging industry, its developments and regulations, and the latest technological trends and innovations.

Key Points: 
  • IDTechEx's report " Charging Infrastructure for Electric Vehicles and Fleets 2024-2034 " covers the trends and developments in the EV charging industry.
  • The IDTechEx charging infrastructure market report provides an in-depth coverage of multiple types of EV charging solutions including private AC charging, public DC charging, megawatt charging, battery swapping, and wireless charging.
  • Technologies like destination or wallbox DC chargers, megawatt charging, robotic charging, battery-buffered charging, off-grid charging, and mobile charging are some examples of the emerging EV charging solutions included in the research from IDTechEx.
  • IDTechEx has the most comprehensive EV charging research portfolio spanning major technologies like traditional conductive charging , wireless charging , battery swapping , and off-grid charging encompassing all vehicle segments already being electrified.

Current Affairs: The Trends Shaping EV Charging Technology, Reports IDTechEx

Retrieved on: 
木曜日, 4月 18, 2024
Hydrogen, MCS, HDV, Toyota, Volvo, BEV, Traction, Electricity, Research, Watt, CCS, CONFIG.SYS, EV, Fleet, Hitachi, GM, Electric vehicle, AC, Daimler, Government, Growth, Players

BOSTON, April 18, 2024 /PRNewswire/ -- Based on their ongoing research into the EV charging market, IDTechEx estimates that 222 million chargers will be needed by 2034 to support the growing global EV fleet. IDTechEx also predicts that the cumulative global investment in global charging infrastructure will exceed $123 billion by 2034 (hardware cost alone). IDTechEx research aims to keep up with the changes and developments in EV charging by monitoring and analyzing the EV charging industry, its developments and regulations, and the latest technological trends and innovations.

Key Points: 
  • IDTechEx's report " Charging Infrastructure for Electric Vehicles and Fleets 2024-2034 " covers the trends and developments in the EV charging industry.
  • The IDTechEx charging infrastructure market report provides an in-depth coverage of multiple types of EV charging solutions including private AC charging, public DC charging, megawatt charging, battery swapping, and wireless charging.
  • Technologies like destination or wallbox DC chargers, megawatt charging, robotic charging, battery-buffered charging, off-grid charging, and mobile charging are some examples of the emerging EV charging solutions included in the research from IDTechEx.
  • IDTechEx has the most comprehensive EV charging research portfolio spanning major technologies like traditional conductive charging , wireless charging , battery swapping , and off-grid charging encompassing all vehicle segments already being electrified.

Bluejay Announces Receipt of PRIME Designation from European Medicines Agency (EMA) for BJT-778 for the Treatment of Chronic Hepatitis Delta Virus Infection

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月曜日, 3月 25, 2024
Therapy, Patient, SAN, HDV, European Medicines Agency, PRIME, Hepatology, Immunoglobulin G, Blue jay, Disease, EMA

SAN MATEO, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- Bluejay Therapeutics, Inc., a private clinical-stage biopharmaceutical company focused on viral and liver diseases, today announced the European Medicines Agency (EMA) has granted Priority Medicine (PRIME) designation to BJT-778 for the treatment of Chronic Hepatitis Delta Virus (HDV) infection.

Key Points: 
  • SAN MATEO, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- Bluejay Therapeutics, Inc., a private clinical-stage biopharmaceutical company focused on viral and liver diseases, today announced the European Medicines Agency (EMA) has granted Priority Medicine (PRIME) designation to BJT-778 for the treatment of Chronic Hepatitis Delta Virus (HDV) infection.
  • BJT-778 is a high-potency, fully human immunoglobulin G1 (IgG1) mAb that acts as an anti-viral to HDV by neutralizing and facilitating the clearance of HDV virions.
  • The application for PRIME designation was bolstered by compelling data from non-clinical studies, along with interim results from the company's Phase 1/2 study that included subjects with chronic HDV.
  • “We eagerly anticipate our continued collaboration with the EMA and other regulatory agencies to expedite the availability of this promising treatment for patients.”

Vir Biotechnology Completes Enrollment of Phase 2 Chronic Hepatitis Delta SOLSTICE Trial Ahead of Schedule

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火曜日, 3月 5, 2024
Biotechnology, Infectious Diseases, Health, Pharmaceutical, Clinical Trials, Alanine transaminase, HDV, ALT, Clinical research, Cirrhosis, Safety, RNA, CHD, Patient, Clinical trial, Hepatitis, Pharmaceutical industry

Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that its Phase 2 SOLSTICE clinical trial evaluating the safety, tolerability and efficacy of tobevibart and elebsiran for the treatment of people living with chronic hepatitis delta (CHD) virus has completed enrollment of its current cohorts one month earlier than anticipated.

Key Points: 
  • Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that its Phase 2 SOLSTICE clinical trial evaluating the safety, tolerability and efficacy of tobevibart and elebsiran for the treatment of people living with chronic hepatitis delta (CHD) virus has completed enrollment of its current cohorts one month earlier than anticipated.
  • Initial data are expected in the second quarter of 2024.
  • SOLSTICE is a Phase 2 multi-center, open-label trial designed to evaluate the safety, tolerability, and efficacy of tobevibart and elebsiran in adult participants (age 18 to 69) with CHD infection receiving nucleot(s)ide reverse transcriptase inhibitor therapy.
  • Depending on the cohort, trial participants are receiving multiple doses of tobevibart and elebsiran as either monotherapy or in combination administered via subcutaneous injection for up to 88 weeks.