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Zoetis (ZTS) Receives Positive Opinion from CVMP for Portela®
Yahoo Finance· 2025-09-16 18:58
Core Insights - Zoetis Inc. (NYSE:ZTS) is recognized as a strong investment opportunity in the pharmaceutical sector, particularly following the positive opinion from the Committee for Veterinary Medicinal Products (CVMP) regarding the marketing authorization for Portela (relfovetmab) [1][2] Company Overview - Zoetis Inc. is a global leader in animal health, focusing on the discovery, development, manufacture, and commercialization of a wide range of products including vaccines, medicines, and diagnostic tools [2] - The company operates in two main segments: the United States and International, each with a diversified product portfolio that includes vaccines, parasiticides, and pain management solutions [2] Product Development - Portela is a new monoclonal antibody therapy aimed at providing pain relief for osteoarthritis in cats, with the potential to be the first long-acting anti-nerve growth factor mAb therapy for this purpose [2] - If approved, Portela is designed to deliver three months of pain relief with a single injection, targeting nerve growth factor, which plays a crucial role in osteoarthritis pain [2] Market Presence - Zoetis markets its products in approximately 45 countries and specializes in various animal species, including companion animals (dogs, cats, horses), cattle, swine, and poultry [2]
SPEAR Study Group to Present its Recommended Long COVID Antibody Study Design Featuring Invivyd's VYD2311 At RECOVER-TLC Workshop September 9-10, 2025
Globenewswire· 2025-09-04 11:01
Core Viewpoint - Invivyd, Inc. announced that the SPEAR Study Group has issued a consensus recommendation for a clinical study design to evaluate monoclonal antibody therapy for Long COVID, which will be presented to the NIH initiative RECOVER-TLC [1][2]. Group 1: Study Design and Objectives - The SPEAR Study Group aims to explore the role of persistent viral reservoirs and circulating spike protein in Long COVID through a proposed clinical study focusing on broadly neutralizing anti-SARS-CoV-2 spike protein monoclonal antibodies, including VYD2311 [2][5]. - Key elements of the proposed clinical study include deploying high levels of neutralizing monoclonal antibodies over the long term, a randomized placebo-controlled design with over 100 patients per arm, and measuring reduction in detectable spike antigen as a critical endpoint [6][5]. - The study will also explore potential symptom improvement using standardized instruments to correlate the modification of underlying chronic infection with clinical benefits [6][5]. Group 2: Presentation and Workshop - Drs. Amy Proal and David Putrino will present the proposed study design at the Second Annual RECOVER-TLC Workshop on September 9-10, 2025, in Bethesda, Maryland [3]. - Dr. David Putrino will present the study design for funding consideration on September 10, 2025, at 9:25 a.m. ET, while Dr. Amy Proal will discuss the antiviral landscape and implications for Long COVID research later that day at 1:00 p.m. ET [3]. Group 3: VYD2311 Overview - VYD2311 is a novel monoclonal antibody candidate developed to address the urgent need for new therapeutic options for COVID-19, with a pharmacokinetic profile that may allow for patient-friendly administration [7][8]. - The antibody was engineered using Invivyd's proprietary technology platform and is designed to neutralize contemporary virus lineages, leveraging the same backbone as other investigational mAbs with emergency use authorization [8][9].
Invivyd Commends FDA Focus on Contemporary Evidence In Evaluating Medical Interventions To Prevent COVID-19
Globenewswire· 2025-05-21 13:30
Core Insights - Invivyd, Inc. commends the FDA for addressing uncertainties regarding COVID-19 vaccine booster efficacy and providing a pathway to resolve these issues [1][4] - The FDA has encouraged manufacturers to conduct randomized, placebo-controlled trials to evaluate the efficacy of COVID-19 vaccines, particularly in individuals who have had COVID-19 within the past year [2][4] - Invivyd's CANOPY Phase 3 clinical trial of pemivibart demonstrated an 84% reduction in the risk of symptomatic COVID-19 compared to placebo, highlighting the potential of monoclonal antibodies as a viable alternative to vaccines [2][3][4] FDA's Actions and Recommendations - The FDA has identified gaps in the understanding of COVID-19 vaccine booster efficacy and has called for trials to include healthy adults and those who have had COVID-19 recently [2][4] - The FDA considers a 30% reduction in symptomatic COVID-19 as "meaningful" protection, while Invivyd's pemivibart showed an 84% reduction, suggesting a significantly higher level of efficacy [3][4] Invivyd's Clinical Trials and Products - The CANOPY Phase 3 trial included a randomized cohort of individuals at risk of acquiring SARS-CoV-2, with a follow-up period of six months to assess the durability of the vaccine's efficacy [2][14] - Invivyd plans to advance next-generation monoclonal antibodies to improve scalability and efficacy, with an update on investigational mAb VYD2311 expected soon [4][6][15] Monoclonal Antibodies as a Treatment Option - The FDA has acknowledged the uncertainty surrounding the benefits of repeat COVID-19 vaccine boosters, positioning monoclonal antibody therapies like pemivibart as a critical alternative [4][5] - Invivyd emphasizes the importance of monoclonal antibodies for high-risk populations, particularly children, due to the limitations of vaccination strategies [5][6] Future Developments - Invivyd is set to engage with the FDA on expedited pathways for developing scalable COVID-19 prevention and treatment options, addressing the ongoing health crisis posed by COVID-19 [4][6][17] - The company is focused on delivering high-quality protection against COVID-19, with a commitment to advancing innovative antibody candidates [17]