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    ViiV Healthcare showcases breadth of clinical and real-world evidence at EACS and IDWeek 2025

    10/9/25 9:00:00 AM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $PFE alert in real time by email
    • Data from the CLARITY study will provide insights on acceptability and tolerability of single-dose cabotegravir and lenacapavir long-acting injections
    • Four-year analysis from the OPERA cohort examines continued use of Vocabria + Rekambys and virologic outcomes across age groups
    • 96-week virological efficacy data for Dovato vs Biktarvy will be presented from the PASO DOBLE head-to-head study
    • Safety and tolerability results from the phase IIb EMBRACE study will be presented for VH109 (N6LS), an investigational broadly neutralising antibody administered every four months, in combination with cabotegravir long-acting for HIV treatment

    ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the presentation of more than 60 abstracts, including data from its industry-leading long-acting HIV treatment and prevention portfolio, at the 20th European AIDS Conference (EACS) in Paris, France from 15-18 October, and at IDWeek 2025 in Atlanta, Georgia, US from 19-22 October.

    Highlights include initial data from the phase I CLARITY crossover study, the first comparing the acceptability and tolerability of cabotegravir long-acting (CAB LA) and lenacapavir (LEN) injections after a single dose.1 New effectiveness and tolerability data for Vocabria + Rekambys (cabotegravir + rilpivirine LA; branded as Cabenuva in the US, Canada and Australia), Apretude (CAB LA for PrEP), and pipeline data on innovative combination approaches in HIV treatment, reinforce ViiV Healthcare's leadership in HIV long-acting innovation.

    Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, said: "The breadth of our data presented at EACS and IDWeek reinforce the effectiveness of our therapies, the potential promise of our pipeline and our unwavering commitment to meeting the evolving needs of those impacted by HIV. The CLARITY study, comparing single dose injections of cabotegravir and lenacapavir, offers critical insights into patient and provider preferences, empowering informed decisions and building on our substantial body of real-world evidence in long-acting HIV treatment and prevention."

    Key data to be presented at EACS and IDWeek by ViiV Healthcare and study partners include:

    New clinical data assessing acceptability and tolerability of single-dose CAB LA and LEN injections: At EACS, initial data from a primary analysis of the phase I CLARITY study – a randomised crossover study of long-acting injectable antiretrovirals in 63 HIV-negative adults – will highlight acceptability and tolerability of CAB LA vs LEN following a single dose.1 The study will show clinically relevant differences in injection site reactions (ISRs) experienced by participants following administration.

    New real-world evidence for CAB LA for PrEP: At IDWeek, a range of studies will provide insights into the real-world data of CAB LA in HIV prevention including: the PrEPFACTS study, which will reveal US testing patterns and evidence of HIV; US data on HIV testing from the OPERA cohort, which will report on how CAB LA or oral PrEP is administered in the real world to help support optimal HIV care; interim findings from the phase IV EBONI study on Black women's experiences of CAB LA, providing insights from a group that accounts for approximately half of new HIV diagnoses among women in the US.2,3,4,5

    Reinforcing the established data for HIV treatment with cabotegravir + rilpivirine (CAB+RPV LA) in a broad range of populations: At EACS, a meta-analysis of 26 studies involving more than 7,000 virologically suppressed people living with HIV will provide real-world effectiveness, adherence and tolerability data for CAB+RPV LA.6 At IDWeek, a four-year analysis from the OPERA cohort of length of time people stay on CAB+RPV LA and their virologic outcomes across age groups provides insights into its use and effectiveness over time.7

    Phase III study of healthcare providers' perspectives on treatment optimisation: At EACS, the phase III VOLITION study will report perspectives from healthcare providers on early switch to CAB+RPV LA after rapid suppression in ART-naive adults with Dovato (dolutegravir/lamivudine (DTG/3TC)).8 The findings build on previous VOLITION data on the efficacy, safety, implementation effectiveness, and patient-reported outcomes from participants who had the option to choose between these two regimens based on individual preference.9,10

    New long-term efficacy data for ViiV Healthcare's two-drug regimen DTG/3TC: At EACS, 96-week results from PASO DOBLE, the largest head-to-head randomised clinical trial of DTG/3TC vs bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), will explore virological efficacy and metabolic outcomes.11 In addition, findings will be presented from the Fundación Huésped-sponsored DOLCE study that assessed DTG/3TC in virologically suppressed adults with low CD4 counts (<200 cells/mL).12 At EACS and IDWeek, the retrospective real-world global REGAL study will compare DTG/3TC and BIC/FTC/TAF in older people living with HIV.13,14,15

    Advancing innovative approaches in HIV treatment: At EACS, new data will be presented from the phase IIb EMBRACE study of N6LS, an investigational broadly neutralising antibody (bNAb) in combination with CAB LA for HIV treatment.16,17,18,19 Presentations will include safety and tolerability results from intravenous and subcutaneous administration in Part 1 of the study, pharmacokinetic parameters in virologically suppressed adults, and perspectives from people living with HIV and clinical staff on using N6LS with CAB LA injections.

    Key ViiV Healthcare sponsored or supported studies to be presented at EACS 2025:

    Title

    Presenting author

    Presentation

    CAB+RPV LA

    The Power of Choice: Perspectives From Healthcare Providers on Early Switch to CAB+RPV LA After Rapid Suppression With DTG/3TC

    C. A. Gutner

    Oral presentation (RO2.5)

    October 17 2025

    12:30 PM - 1:30 PM CEST

    Real-World Effectiveness and Tolerability of Cabotegravir + Rilpivirine Long-Acting in People Living with HIV-1: A Meta-Analysis of Real-World Evidence

    C. Orkin

    ePoster exhibition (eP103)

    October 16 2025

    Real-World Utilization of Cabotegravir/Rilpivirine Long-Acting Injectable: An Observational Analysis of Adherence and Persistence using a Patient Support Program in Canada

    J. F. Fortin

    ePoster exhibition (eP106)

    October 16 2025

     

     

    CAB LA for PrEP

    Opportunities to Prevent Human Immunodeficiency Virus (HIV) Acquisition: Global Survey Results on Sexual Health Engagement in Newly Diagnosed People Living With HIV From the VOLITION Study

    C. A. Gutner

    ePoster exhibition (eP456)

    October 16 2025

    Cabotegravir Injections Are More Acceptable Than Lenacapavir Injections Following a Single Dose: Results From CLARITY, a Randomized Crossover Study of Long-Acting Injectable Antiretrovirals

    K. Brown

    Moderated ePoster (MeP20.4.LB)

    October 17 2025

    2:05 PM - 2:25 PM CEST

    DTG/3TC

    PAtIent Reported Experiences and perceiveD benefit of treatment with dolutegravir/lamivudine in Europe (PAIRED Europe): Primary Analysis

    E. Fernvik

    ePoster exhibition (eP095)

    October 16 2025

    The European REGAL Cohort: A Retrospective Real-world Study of the Effectiveness and Tolerability of the Antiretroviral Treatment Regimens DTG/3TC Compared to BIC/FTC/TAF in Older Persons Living with HIV

    M. Jesus Perez Elías

    ePoster exhibition (eP115)

    October 16 2025

    Real-world Effectiveness of DTG+3TC in PLHIV With Previous ART Experience but no Genotype Testing: The "AReTi" Study Results

    D. Athanasopoulos

    ePoster exhibition (eP104)

    October 16 2025

    CARAVEL: evaluation of real-world antiviral effectiveness and sustainability of the 2-drug regimen Dolutegravir/ Lamivudine fixed dose combination in treatment-naïve adults and pre-treated adults who are virologically suppressed, in routine clinical care, in France

    P. Philibert

    ePoster exhibition (eP049)

    October 16 2025

    TR-DOLA: Real-world data on the use of Dolutegravir (DTG) + Lamivudine (3TC) in treatment-experienced people living with HIV in TURKIYE

    T. Demirdal

    ePoster exhibition (eP117)

    October 16 2025

    Subgroup Analysis of Dolutegravir/ Lamivudine-in ART-Naïve Adults Living with HIV with CD4 counts below 200 cells/mL: Results from the DOLCE Study

    C. Brites

    ePoster Exhibition (eP134)

    October 16 2025

     

    Virological non-inferiority and lower weight gain with DTG/3TC versus BIC/FTC/TAF: 96-week final results from the PASO-DOBLE (GeSIDA 11720) randomised, multicentre, open-label, non-inferiority trial

    E. Martínez

    Oral presentation (RO3.8.LB)

    October 17 2025

    12:30 PM - 1:30 PM CEST

     

    VH109 (N6LS)

    Cutoff for Baseline Phenotypic Sensitivity to VH3810109 (N6LS) Did Not Impact Occurrence of Confirmed Virologic Failure in the Phase 2b EMBRACE Study

    M. Gartland

    ePoster exhibition (eP127)

    October 16 2025

    Safety and Tolerability of N6LS Administered Intravenously or Subcutaneously: Promising Results From Part 1 of the EMBRACE Study

    P. Leone

    Oral Presentation (PS09.1)

    October 17 2025

    11:00 AM – 12:00 PM CEST

    Evaluation of VH3810109 (N6LS) and Cabotegravir Long-Acting, Dual Modality, Injections for HIV Treatment: People With HIV and Staff Perspectives

    C. A. Gutner

    ePoster exhibition (eP131)

    October 16 2025

    Population Pharmacokinetics, Antidrug Antibodies and Exposure-Response of VH3810109 (N6LS) in Virologically Suppressed Adults Living With HIV From the Phase 2b EMBRACE Study

    A. Yin Edwards

    ePoster Exhibition (MeP10.1)

    October 16 2025

    3:35 PM – 3:40 PM CEST

    Key ViiV Healthcare sponsored or supported studies to be presented at IDWeek 2025:

    Title

    Presenting author

    Presentation

    CAB+RPV LA

    Few differences in persistence and virologic outcomes across age groups among CAB+RPV LA users: Findings from the OPERA Cohort

    M. Sension

    Poster Session (P-371)

    October 20 2025

    12:15 PM – 1:30 PM ET

    PREFER-LA: People with HIV (PWH) in the United States with prior adherence challenges with oral antiretroviral therapy (ART) prefer cabotegravir + rilpivirine long-acting (CAB+RPV LA) therapy after switch

    Z. Henry

    Poster session (P-396)

    October 20 2025

    12:15 PM – 1:30 PM ET

    PREFER-LA: Improved adherence and viral control in real-world study of people with HIV (PWH) in the United States with adherence challenges on oral antiretroviral therapy (ART) switching to cabotegravir + rilpivirine long-acting (CAB+RPV LA)

    W. Short

    Oral Session (575)

    October 22 2025

    11:06 AM – 11:18 AM ET

    CAB LA for PrEP

    Associations between Intersectional Stigma and Long-Acting Injectable PrEP (LAI-PrEP) Willingness and Preference among Gay, Bisexual, and other Men who have Sex with Men (GBMSM)

    J. Glick

    Poster Session (P-306)

    October 20 2025

    12:15 PM – 1:30 PM ET

    Characteristics associated with HIV pre-exposure prophylaxis persistence among men who have sex with men in the United States: results from the American men's internet survey (AIMS) 2023-24

    D. Islek

    Poster Session (P-300)

    October 20 2025

    12:15 PM – 1:30 PM ET

    Screening Practices for HIV and Sexually Transmitted Infections During Cabotegravir Long Acting or Daily Oral Pre-Exposure Prophylaxis Use in the US

    S. Barnett

    Poster Session (P-332)

    October 20 2025

    12:15 PM – 1:30 PM ET

    Black Women's Experiences on Long-Acting Cabotegravir for PrEP: Interim Patient Findings from the EBONI Study

    K. Nelson

    Poster Session (P-313)

    October 20 2025

    12:15 PM – 1:30 PM ET

    Human Immunodeficiency Virus (HIV) Testing and Evidence of HIV among Real-World Long-Acting Pre-Exposure Prophylaxis (PrEP) Users in a United States Claims Database: Results from the PrEPFACTS Study

    A. Metzner

    Oral Session (574)

    October 22 2025

    10:54 AM – 11:06 AM ET

    DTG/3TC

    The US REGAL cohort: a retrospective real-world study of the effectiveness and tolerability of the antiretroviral treatment regimens DTG/3TC compared to BIC/FTC/TAF in older persons living with HIV

    O. Ogbuagu

    Poster Session (P-376)

    October 20 2025

    12:15 PM – 1:30 PM ET

    The Global REGAL cohort: A REtrospective real-world study of the effectiveness and tolerability of the antiretroviral treatment reGimens DTG/3TC compAred to BIC/FTC/TAF in older persons Living with HIV

    J. Fraysse

    Poster Session (P-357)

    October 20 2025

    12:15 PM – 1:30 PM ET

    Real-world Effectiveness and Safety Outcomes in People with HIV-1 Switching to Dolutegravir + Lamivudine (DTG + 3TC) with Unknown Prior Genotype: a Systematic Literature Review and Meta-analysis

    J. Boulos

    Poster Session (P-360)

    October 20 2025

    12:15 PM – 1:30 PM ET

    About Apretude (cabotegravir long-acting)

    Apretude is a medicine used for preventing sexually transmitted HIV-1 infection (pre-exposure prophylaxis or PrEP) in adults and adolescents weighing at least 35 kg who are at high risk of being infected. Individuals must have a negative HIV-1 test prior to initiating Apretude (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP. It should be used in combination with safer sex practices, such as using condoms. Apretude contains the active substance cabotegravir.

    Please consult the full Prescribing Information here.

    About Vocabria (cabotegravir)

    Vocabria injection is indicated - in combination with rilpivirine injection - for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse transcriptase inhibitors (NNRTI) and integrase inhibitor (INI) class.

    Vocabria tablets are indicated - in combination with rilpivirine tablets - for the short-term treatment of HIV-1 infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class for:

    • oral lead-in to assess tolerability of Vocabria and rilpivirine prior to administration of long acting Vocabria injection plus long acting rilpivirine injection.
    • oral therapy for adults who will miss planned dosing with Vocabria injection plus rilpivirine injection.

    Vocabria tablets are only indicated for treatment of HIV-1 in combination with rilpivirine tablets, therefore, the prescribing information for Edurant (rilpivirine) tablets should also be consulted for recommended dosing.

    Please consult the full Summary of Product Characteristics for all the safety information: Vocabria 400mg/600 mg prolonged-release suspension for injection and Vocabria 30 mg film-coated tablets

    About Rekambys (rilpivirine)

    Rekambys is indicated - in combination with cabotegravir injection - for the treatment of HIV-1 infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and INI class.

    Rekambys should always be co-administered with a cabotegravir injection. The prescribing information for cabotegravir injection should be consulted for recommended dosing. Rekambys may be initiated with oral lead-in or without (direct to injection).

    Please consult the full Summary of Product Characteristics for all the safety information: Rekambys 600mg/900 mg prolonged-release suspension for injection

    About Cabenuva (cabotegravir + rilpivirine)

    Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/ml) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

    The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland Unlimited Company. Rilpivirine tablets are approved in the US and when used with cabotegravir is indicated for short-term treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35 kg who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

    INSTIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic disease. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which stops the virus from multiplying.

    Please consult the full Prescribing Information here.

    About Dovato (dolutegravir and lamivudine)

    Dovato is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.

    Please consult the full Prescribing Information here.

    Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

    About ViiV Healthcare

    ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE:PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who could benefit from HIV prevention. Shionogi became a ViiV shareholder in October 2012. The company's aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

    For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com.

    About GSK

    GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

    Cautionary statement regarding forward-looking statements

    GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2024, and GSK's Q2 Results for 2025.

    Registered in England & Wales:

    GSK plc ViiV Healthcare Limited

    No. 3888792 No. 06876960

    Registered Office:

    79 New Oxford Street ViiV Healthcare Limited

    London GSK Medicines Research Centre

    WC1A 1DG Gunnels Wood Road, Stevenage

    United Kingdom

    SG1 2NY

    References

    ____________________

    1 J. Boles, et al. Cabotegravir Injections Are More Acceptable Than Lenacapavir Injections Following a Single Dose: Results From CLARITY, a Randomized Crossover Study of Long-Acting Injectable Antiretrovirals. Presented at the European AIDS Conference (EACS 2025), 15-18 October, Paris, FR.

    2 A. Metzner, et al. Human Immunodeficiency Virus (HIV) Testing and Evidence of HIV among Real-World Long-Acting Pre-Exposure Prophylaxis (PrEP) Users in a United States Claims Database: Results from the PrEPFACTS Study. Presented at IDWeek 2025, 19-22 October, Atlanta, GA.

    3 S. Barnett, et al. Screening Practices for HIV and Sexually Transmitted Infections During Cabotegravir Long Acting or Daily Oral Pre-Exposure Prophylaxis Use in the US. Presented at IDWeek 2025, 19-22 October, Atlanta, GA.

    4 K. Nelson, et al. Black Women's Experiences on Long-Acting Cabotegravir for PrEP: Interim Patient Findings from the EBONI Study. Presented at IDWeek 2025, 19-22 October, Atlanta, GA.

    5 Kaiser Family Foundation. The impact of HIV on women in the United States. 2024 Dec 16. Available: https://www.kff.org/hiv-aids/the-impact-of-hiv-on-women-in-the-united-states/ Accessed: October 2025

    6 C. Orkin, et al. Real-World Effectiveness and Tolerability of Cabotegravir + Rilpivirine Long-Acting in People Living with HIV-1: A Meta-Analysis of Real-World Evidence. Presented at the European AIDS Conference (EACS 2025), 15-18 October, Paris, FR.

    7 M. Sension, et al. Few differences in persistence and virologic outcomes across age groups among CAB+RPV LA users: Findings from the OPERA Cohort. Presented at IDWeek 2025, 19-22 October, Atlanta, GA.

    8 C. Jonsson-Oldenbütel, et al. The Power of Choice: Perspectives From Healthcare Providers on Early Switch to CAB+RPV LA After Rapid Suppression With DTG/3TC. Presented at the European AIDS Conference (EACS 2025), 15-18 October, Paris, FR.

    9 E. Cordova, et al. Rapid virologic suppression with DTG/3TC facilitates early switch to CAB+RPV LA for treatment-naive people living with HIV: suppression phase outcomes from the Phase 3b VOLITION study. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW.

    10 F. Felizarta, et al. The power of choice: strong preference for CAB+RPV LA following rapid suppression with DTG/3TC in treatment naive people living with HIV. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW.

    11 M. Masia, et al. Virological non-inferiority and lower weight gain with DTG/3TC versus BIC/FTC/TAF: 96-week final results from the PASO-DOBLE (GeSIDA 11720) randomised, multicentre, open-label, non-inferiority trial. Presented at the European AIDS Conference (EACS 2025), 15-18 October, Paris, FR.

    12 C. Brites, et al. Subgroup Analysis of Dolutegravir/Lamivudine-in ART-Naïve Adults Living with HIV with CD4 counts below 200 cells/mL: Results from the DOLCE Study. Presented at the European AIDS Conference (EACS 2025), 15-18 October, Paris, FR.

    13 M. Jesus Perez Elías, et al. The European REGAL Cohort: A Retrospective Real-world Study of the Effectiveness and Tolerability of the Antiretroviral Treatment Regimens DTG/3TC Compared to BIC/FTC/TAF in Older Persons Living with HIV. Presented at the European AIDS Conference (EACS 2025), 15-18 October, Paris, FR.

    14 J. Fraysse, et al. The Global REGAL cohort: A REtrospective real-world study of the effectiveness and tolerability of the antiretroviral treatment reGimens DTG/3TC compared to BIC/FTC/TAF in older persons Living with HIV. Presented at IDWeek 2025, 19-22 October, Atlanta, GA.

    15 O. Ogbuagu, et al. The US REGAL Cohort: A Retrospective Real-world Study of the Effectiveness and Tolerability of the Antiretroviral Treatment Regimens DTG/3TC Compared to BIC/FTC/TAF in Older Persons Living with HIV. Presented at IDWeek 2025, 19-22 October, Atlanta, GA.

    16 Leone P, et al. Safety and tolerability of N6LS administered intravenously or subcutaneously: promising results from Part 1 of the EMBRACE study. Presented at the European AIDS Conference (EACS 2025), 15-18 October, Paris, FR.

    17 C. A. Gutner, et al. Evaluation of VH3810109 (N6LS) and Cabotegravir Long-Acting, Dual Modality, Injections for HIV Treatment: People With HIV and Staff Perspectives. Presented at the European AIDS Conference (EACS 2025), 15-18 October, Paris, FR.

    18 M. Gartland, et al. Cutoff for Baseline Phenotypic Sensitivity to VH3810109 (N6LS) Did Not Impact Occurrence of Confirmed Virologic Failure in the Phase 2b EMBRACE Study. Presented at the European AIDS Conference (EACS 2025), 15-18 October, Paris, FR.

    19 A. Yin Edwards, et al. Population Pharmacokinetics, Antidrug Antibodies and Exposure-Response of VH3810109 (N6LS) in Virologically Suppressed Adults Living With HIV From the Phase 2b EMBRACE Study. Presented at the European AIDS Conference (EACS 2025), 15-18 October, Paris, FR.

     

    View source version on businesswire.com: https://www.businesswire.com/news/home/20251009932337/en/

    ViiV Healthcare enquiries:

    Media:

    Rachel Jaikaran +44 (0) 78 2352 3755 (London)

    Melinda Stubbee +1 919 491 0831 (North Carolina)

    GSK enquiries:

    Media:

    Simon Steel +44 (0) 20 8047 5502 (London)

    Sarah Clements +44 (0) 20 8047 5502 (London)

    Kathleen Quinn +1 202 603 5003 (Washington DC)

    Alison Hunt +1 540 742 3391 (Washington DC)

    Investor Relations:

    Constantin Fest +44 (0) 7831 826525 (London)

    James Dodwell +44 (0) 20 8047 2406 (London)

    Mick Readey +44 (0) 7990 339653 (London)

    Steph Mountifield +44 (0) 7796 707505 (London)

    Jeff McLaughlin +1 215 751 7002 (Philadelphia)

    Frannie DeFranco +1 215 751 3126 (Philadelphia)

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    Board of Directors approves quarterly cash dividend of $0.43 per share Pfizer Inc. (NYSE:PFE) today announced that its board of directors declared a $0.43 fourth-quarter 2025 dividend on the company's common stock, payable December 1, 2025, to holders of the Common Stock of record at the close of business on November 7, 2025. The fourth-quarter 2025 cash dividend will be the 348th consecutive quarterly dividend paid by Pfizer. About Pfizer: Breakthroughs That Change Patients' Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discov

    10/9/25 4:30:00 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    ViiV Healthcare showcases breadth of clinical and real-world evidence at EACS and IDWeek 2025

    Data from the CLARITY study will provide insights on acceptability and tolerability of single-dose cabotegravir and lenacapavir long-acting injections Four-year analysis from the OPERA cohort examines continued use of Vocabria + Rekambys and virologic outcomes across age groups 96-week virological efficacy data for Dovato vs Biktarvy will be presented from the PASO DOBLE head-to-head study Safety and tolerability results from the phase IIb EMBRACE study will be presented for VH109 (N6LS), an investigational broadly neutralising antibody administered every four months, in combination with cabotegravir long-acting for HIV treatment ViiV Healthcare, the global specialist HIV compa

    10/9/25 9:00:00 AM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Pfizer Reaches Landmark Agreement with U.S. Government to Lower Drug Costs for American Patients

    Voluntary agreement meets the President's four requests while also protecting the U.S. ecosystem responsible for America's leadership in delivering medical breakthroughs Agreement provides certainty from tariffs and clarity on pricing framework that furthers Pfizer's ability to expand investment in U.S.-based innovation and return manufacturing to the U.S. Pfizer to fully focus on delivering the next generation of cures, especially in cancer, obesity, vaccines, and inflammation and immunology Pfizer CEO Albert Bourla joins President Donald J. Trump and members of his Administration in White House event today Pfizer Inc. (NYSE:PFE) today announced a historic agreement with the T

    9/30/25 12:45:00 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    $PFE
    FDA approvals

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    October 25, 2024 - FDA Roundup: October 25, 2024

    For Immediate Release: October 25, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA updated the advisory for the outbreak of E. coli O157:H7. A specific ingredient has not yet been confirmed as the source of the outbreak, but most sick people report eating McDonald’s Quarter Pounder burgers. Investigators are working to deter

    10/25/24 2:48:21 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    FDA Approval for HYMPAVZI issued to PFIZER INC

    Submission status for PFIZER INC's drug HYMPAVZI (ORIG-1) with active ingredient MARSTACIMAB-HNCQ has changed to 'Approval' on 10/11/2024. Application Category: BLA, Application Number: 761369, Application Classification:

    10/15/24 2:57:27 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    October 11, 2024 - FDA Approves New Treatment for Hemophilia A or B

    For Immediate Release: October 11, 2024 Today, the U.S. Food and Drug Administration approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors (neutralizing antibodies). “Today’s approval of Hympavzi pro

    10/11/24 2:12:15 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    $PFE
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    Director Blaylock Ronald E bought $499,072 worth of shares (19,457 units at $25.65), increasing direct ownership by 236% to 27,707 units (SEC Form 4)

    4 - PFIZER INC (0000078003) (Issuer)

    2/14/25 5:16:36 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Director Gottlieb Scott bought $28,240 worth of shares (1,000 units at $28.24), increasing direct ownership by 11% to 10,000 units (SEC Form 4)

    4 - PFIZER INC (0000078003) (Issuer)

    10/31/24 4:06:54 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Gottlieb Scott bought $79,401 worth of shares (3,000 units at $26.47), increasing direct ownership by 50% to 9,000 units (SEC Form 4)

    4 - PFIZER INC (0000078003) (Issuer)

    12/19/23 9:31:01 AM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    $PFE
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    SEC Form 4 filed by Director Taraporevala Cyrus

    4 - PFIZER INC (0000078003) (Issuer)

    10/2/25 4:56:13 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    SEC Form 4 filed by Director Smith James C

    4 - PFIZER INC (0000078003) (Issuer)

    10/2/25 4:56:12 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    SEC Form 4 filed by Director Quincey James

    4 - PFIZER INC (0000078003) (Issuer)

    10/2/25 4:55:10 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

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    SEC Form 13F-HR filed by Pfizer Inc.

    13F-HR - PFIZER INC (0000078003) (Filer)

    8/11/25 5:08:12 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    SEC Form 10-Q filed by Pfizer Inc.

    10-Q - PFIZER INC (0000078003) (Filer)

    8/5/25 7:16:27 AM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Pfizer Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Financial Statements and Exhibits

    8-K - PFIZER INC (0000078003) (Filer)

    8/5/25 7:08:22 AM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
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    Leadership Updates

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    Pfizer Reaches Landmark Agreement with U.S. Government to Lower Drug Costs for American Patients

    Voluntary agreement meets the President's four requests while also protecting the U.S. ecosystem responsible for America's leadership in delivering medical breakthroughs Agreement provides certainty from tariffs and clarity on pricing framework that furthers Pfizer's ability to expand investment in U.S.-based innovation and return manufacturing to the U.S. Pfizer to fully focus on delivering the next generation of cures, especially in cancer, obesity, vaccines, and inflammation and immunology Pfizer CEO Albert Bourla joins President Donald J. Trump and members of his Administration in White House event today Pfizer Inc. (NYSE:PFE) today announced a historic agreement with the T

    9/30/25 12:45:00 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Dexcom Appoints Jon Coleman as Chief Commercial Officer

    DexCom, Inc. (NASDAQ:DXCM), the global leader in glucose biosensing, today announced the appointment of Jon Coleman as chief commercial officer. In this role, Mr. Coleman will assume responsibility for Dexcom's global commercial organization, including global sales, marketing and customer experience. Mr. Coleman joins Dexcom with more than 30 years of global commercial leadership experience across multiple healthcare segments and channels. Mr. Coleman served as an executive officer of Masimo Corporation (NASDAQ:MASI), where he held roles of increasing responsibility across his fifteen-year tenure. This included serving as president of Masimo's commercial teams where he oversaw the consolid

    3/25/25 4:05:00 PM ET
    $DXCM
    $MASI
    $PFE
    Medical/Dental Instruments
    Health Care
    Biotechnology: Electromedical & Electrotherapeutic Apparatus
    Biotechnology: Pharmaceutical Preparations

    FoRx Therapeutics Appoints Chief Medical Officer and Provides an Update on Its Lead Development Candidate

    Industry veteran in clinical development of oncology therapeutics, Dr. Jens Wurthner, PhD, joins as Chief Medical Officer Lead development candidate, FORX-428, a PARG inhibitor for solid tumors, maintains progress toward IND submission by mid-2025 FoRx Therapeutics AG, a Swiss-based company committed to discovering and developing innovative drugs targeting cancer-relevant DDR (DNA Damage Response) pathways, today announced that it has appointed Jens Würthner, MD PhD, as Chief Medical Officer. He is further strengthening FoRx Therapeutics' existing management team with CEO Tarig Bashir, CSO Frank Zenke, and Head of Chemistry Ulrich Lücking. Jens Würthner has 20+ years of clinical devel

    2/26/25 9:00:00 AM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    $PFE
    Large Ownership Changes

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    SEC Form SC 13G/A filed by Pfizer Inc. (Amendment)

    SC 13G/A - PFIZER INC (0000078003) (Subject)

    2/9/23 11:30:22 AM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    SEC Form SC 13D filed by Pfizer Inc.

    SC 13D - PFIZER INC (0000078003) (Filed by)

    7/27/22 4:42:06 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    SEC Form SC 13G/A filed by Pfizer Inc. (Amendment)

    SC 13G/A - PFIZER INC (0000078003) (Subject)

    2/10/22 8:32:46 AM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
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    $PFE
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    Pfizer Declares Fourth-Quarter 2025 Dividend

    Board of Directors approves quarterly cash dividend of $0.43 per share Pfizer Inc. (NYSE:PFE) today announced that its board of directors declared a $0.43 fourth-quarter 2025 dividend on the company's common stock, payable December 1, 2025, to holders of the Common Stock of record at the close of business on November 7, 2025. The fourth-quarter 2025 cash dividend will be the 348th consecutive quarterly dividend paid by Pfizer. About Pfizer: Breakthroughs That Change Patients' Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discov

    10/9/25 4:30:00 PM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Pfizer Invites Public to View and Listen to Webcast of November 4 Conference Call with Analysts

    Pfizer Inc. (NYSE:PFE) invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10:00 a.m. EST on Tuesday, November 4, 2025. The purpose of the call is to provide an update on Pfizer's results, as reflected in the company's Third Quarter 2025 Performance Report, to be issued that morning. To view and listen to the webcast and view the Performance Report, visit our web site at www.pfizer.com/investors. Information on accessing and registering for the webcast will be available at www.pfizer.com/investors beginning today. Participants are advised to register in advance of the conference call. You can also listen to the confer

    9/23/25 10:00:00 AM ET
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Pfizer to Acquire Metsera and its Next-Generation Obesity Portfolio

    Proposed acquisition to add four highly differentiated clinical-stage incretin and amylin programs to Pfizer's pipeline Transaction valued at $47.50 per Metsera share in cash upon closing, for an initial enterprise value of $4.9 billion with a CVR of up to $22.50 per share in additional payments Pfizer to host a public webcast at 8 am EDT today Pfizer Inc. (NYSE:PFE) and Metsera, Inc. (NASDAQ:MTSR) today announced the companies have entered into a definitive agreement under which Pfizer will acquire Metsera, a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and cardiometabolic diseases. The acquisition brings deep expertise and a

    9/22/25 6:45:00 AM ET
    $MTSR
    $PFE
    Biotechnology: Pharmaceutical Preparations
    Health Care