HDV

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

Retrieved on: 
Monday, March 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

Retrieved on: 
Tuesday, March 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.

Gilead to Present Late-Breaking Data and Real-World Evidence Highlighting Innovative Antiviral Portfolio and Research Pipeline at CROI 2024

Retrieved on: 
Monday, February 26, 2024
Biotechnology, FDA, AIDS, Health, Pharmaceutical, Research, Infectious Diseases, Hospitals, Science, COVID-19, Clinical Trials, Senior, Hepatitis B, CROI, Hook effect, RWE, STR, Viral, Virus, DTG, Mortality, Lenacapavir, Hepatitis, HBV, Vesatolimod, Fungal infection, HIV-1, MDR, PWH, HDV, Boxed warning, European, Islatravir, Tablet, European Commission, Liver disease, Omicron, Conference, Safety, ART, Civil service commission, Abstract, Bictegravir, Natural history, Virology, Emtricitabine, Gilead Sciences, MD, Food, Coinfection, Immunodeficiency, European Economic Area, Risk, Prevalence, Dexamethasone, Patient, Tuberculosis, INSIGHT, HIV, Pharmaceutical industry

Outcomes from pipeline research studies will also provide insights into investigational treatment candidates, including the novel combination regimen of lenacapavir plus bictegravir.

Key Points: 
  • Outcomes from pipeline research studies will also provide insights into investigational treatment candidates, including the novel combination regimen of lenacapavir plus bictegravir.
  • Additionally, a late-breaker oral presentation of Week 24 data from the INSIGHT trial evaluating Biktarvy in people with HIV and tuberculosis will be presented.
  • Gilead will present new data evaluating the safety and efficacy of Hepcludex® (bulevirtide) in people living with the coinfections of HIV, hepatitis B (HBV) and hepatitis delta (HDV).
  • Biktarvy combines the novel, unboosted INSTI bictegravir, with the Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) backbone.

Vir Biotechnology Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, February 22, 2024
Biotechnology, Pharmaceutical, AIDS, Health, COVID-19, Infectious Diseases, Health Technology, Clinical Trials, Infection, Bangladesh Technical Education Board, RSV, CHB, Influenza, Peginterferon-alfa, HIV Vaccine Trials Network, GSK, Research, Investment, AASLD, HDV, MBA, Cirrhosis, HHS, Administration, Conditional sentence, Hepatology, RNA, Respiratory syncytial virus, ASPR, COVID, Patient, Family, HCMV, Bill, Development, HIV, Pharmaceutical industry

Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate update and reported financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate update and reported financial results for the fourth quarter and full year ended December 31, 2023.
  • Complete 24-week treatment data for 30 participants per regimen is expected in the fourth quarter of 2024.
  • The MARCH Part B trial is ongoing with 48-week end of treatment data expected in the fourth quarter of 2024.
  • Revenues: Total revenues for the quarter ended December 31, 2023 were $16.8 million compared to $49.4 million for the same period in 2022.

Gilead Sciences Announces Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, February 6, 2024
Oncology, Health, Infectious Diseases, Hospitals, COVID-19, Pharmaceutical, Biotechnology, EPS, IPR, Compugen, Immunotherapy, Food and Drug Administration, ETR, Dow Jones Sustainability Indices, Progression-free survival, Obeldesivir, FDA, Virology, FTC, Hematology, ALL, HDV, Society, Neurotoxicity, Acquisition, HCV, Cell therapy, Acute lymphoblastic leukemia, MYR, Research, HIV, Patient, Tenofovir alafenamide, Food, Infection, Multiple myeloma, Standard of care, OS, Lymphoma, B-cell lymphoma, Table, GAAP, Docetaxel, Lung cancer, Science, Earnings per share, Investment, Liver disease, Risk, ASH, Pharmaceutical industry

Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the fourth quarter and full year 2023.

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the fourth quarter and full year 2023.
  • During the fourth quarter 2023, Gilead paid cash dividends of $943 million and utilized $150 million to repurchase common stock.
  • The Liver Disease portfolio sales were $691 million in the fourth quarter 2023 and remained flat compared to the same period in 2022.
  • Cell Therapy product sales increased 11% to $466 million in the fourth quarter 2023 compared to the same period in 2022.

Assembly Biosciences Provides Anticipated Development Milestones for 2024

Retrieved on: 
Thursday, January 4, 2024
Assembly, Partnership, Outline, Biotechnology, HDV, HBV, Trial of the century, Hepatitis B, Viral, HSV, Patient, Gilead Sciences, Vaccine

Four development candidates anticipated to be in the clinic by the end of 2024, reflecting expansion of R&D portfolio across herpesviruses and hepatitis B and D viruses

Key Points: 
  • Four development candidates anticipated to be in the clinic by the end of 2024, reflecting expansion of R&D portfolio across herpesviruses and hepatitis B and D viruses
    Recently announced long-term partnership with Gilead Sciences, Inc. (Gilead) to address serious viral diseases expands and builds on the progress of Assembly Bio’s antiviral portfolio
    SOUTH SAN FRANCISCO, Calif., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today provided an outline of the anticipated milestones and progress for its clinical pipeline during 2024.
  • “We are thrilled with the rapid progress of multiple programs from our expanded antiviral pipeline, and plan to initiate clinical studies for four development candidates in 2024,” said Jason Okazaki, chief executive officer and president of Assembly Bio.
  • By the end of 2024:
    Two additional candidates are anticipated to enter the clinic:
    ABI-1179, the long-acting HSV helicase-primase inhibitor contributed by Gilead under the collaboration between Assembly Bio and Gilead; and
    ABI-6250, a small molecule orally-bioavailable hepatitis delta virus entry inhibitor.
  • Initial clinical data are expected to be available from both the ABI-5366 first-in-human clinical study and the ABI-4334 Phase 1b study.

Vir Biotechnology to Present New Data from Its Ongoing Phase 2 Chronic Hepatitis Delta and B Trials Today at AASLD’s The Liver Meeting® 2023

Retrieved on: 
Monday, November 13, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Hepatology, INSERM, Immunity, Interferon, Immune system, ALT, HDV, HBsAg, AASLD, Clinical trial, Viral hepatitis, EOT, Patient, Small RNA, Abstract, Week, Monoclonal antibody, Liver, Auckland City Hospital, CHB, University, Peginterferon-alfa, CHD, APHP, Hepatitis, Vir, RNA, Vaccine, Pharmaceutical industry, Communications satellite, Treatment, Medicine

To date, no participants receiving the combination therapy or VIR-3434 monotherapy have experienced ALT elevations relative to their baseline.

Key Points: 
  • To date, no participants receiving the combination therapy or VIR-3434 monotherapy have experienced ALT elevations relative to their baseline.
  • “Chronic hepatitis delta is the most aggressive form of viral hepatitis.
  • Vir will host an investor conference call to discuss the Phase 2 CHD & CHB AASLD data at 1:45 p.m. Pacific Time / 4:45 p.m. Eastern Time on November 13th.
  • A live webcast will be available on https://investors.vir.bio and will be archived on www.vir.bio for 30 days.

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.

Assembly Biosciences Names Anuj Gaggar, MD, PhD, as Chief Medical Officer

Retrieved on: 
Wednesday, November 8, 2023
University of Washington Department of Global Health, Stanford University, Bio, Infection, Therapy, Viral, Biotechnology, Herpes simplex virus, BS, MD, Publication, Doctor of Philosophy, Gilead Sciences, Sofosbuvir, University, Assembly, HCV, Virology, Chemistry, Patient, HDV, HBV, SAN, Pharmaceutical industry

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 announced that Anuj Gaggar, MD, PhD, has joined the company as chief medical officer. Dr. Gaggar is an infectious disease specialist and seasoned executive whose experience has focused on the development of new therapies in viral diseases including chronic hepatitis B virus (HBV), hepatitis C virus (HCV) and hepatitis D virus (HDV) infections.

Key Points: 
  • 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 announced that Anuj Gaggar, MD, PhD, has joined the company as chief medical officer.
  • “We are excited to have Dr. Gaggar join Assembly Bio’s leadership team at an incredibly important time for the organization,” said Jason Okazaki, chief executive officer and president.
  • Dr. Gaggar was a clinical fellow in infectious diseases at the University of California, San Francisco, where he also served as chief resident.
  • He received his MD and PhD from the University of Washington and his BS in chemistry from Stanford University.

Gilead Sciences Announces Third Quarter 2023 Financial Results

Retrieved on: 
Tuesday, November 7, 2023
Biotechnology, Pharmaceutical, AIDS, Oncology, General Health, Health, Infectious Diseases, Hospitals, BIRCH, Food, Pembrolizumab, B-cell lymphoma, Impact of the COVID-19 pandemic on hospitals, EPS, COVID-19, Tax rate, ETR, CAPELLA, Cohort study, Infection, Acute lymphoblastic leukemia, American Association for the Study of Liver Diseases, SARS-CoV-2, Earnings per share, HIV, GAAP, HCV, Safety, Patient, Food and Drug Administration, European Commission, Conference, Obeldesivir, Research, Growth, European, Lung cancer, Total, HDV, PD-L1, Research and development, Incidence, Hepatology, Axicabtagene ciloleucel, Omicron, Liver, Lung, Risk, Science, FTC, Table, Liver disease, HBV, Pharmaceutical industry, Video game, Fine chemical, Security (finance), Virology, Sacituzumab govitecan, Remdesivir

Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the third quarter of 2023.

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the third quarter of 2023.
  • During the third quarter of 2023, Gilead generated $1.8 billion in operating cash flow.
  • During the third quarter of 2023, Gilead repaid $2.3 billion of debt, paid dividends of $953 million and repurchased $300 million of common stock.
  • Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are provided in the accompanying tables.