Attractive safety profile demonstrated across all dosing cohorts and routes of administration (IV, SC, and IM); all reported adverse events (AEs) deemed unrelated or classified as mild to moderate and largely related to injection site and infusion reactions with no serious or severe adverse events observedFollowing a single dose, serum concentrations of VYD2311 remained high at six months with an observed half-life of the IM dose route having the longest duration at 76.0 (CI: 68.5 – 90.7) days Comprehensive ...

Core Insights - Invivyd, Inc. announced the publication of results from its CANOPY Phase 3 clinical trial of pemivibart, demonstrating its safety and efficacy for the prevention of symptomatic COVID-19 in a contemporary U.S. population facing immune-evasive Omicron variants [1][4][6] Group 1: Clinical Trial Overview - The CANOPY Phase 3 clinical trial randomized 788 adult participants across 18 sites, focusing on immunocompromised individuals and those at risk due to regular face-to-face interactions [2][8] - The trial met all primary and exploratory endpoints during a significant COVID-19 transmission period in the U.S. from September 2023 to September 2024 [2][8] - Pemivibart showed an 84% relative risk reduction in symptomatic COVID-19 compared to placebo over six months [4][6] Group 2: Safety and Tolerability - Pemivibart was generally well-tolerated, with most adverse events classified as mild to moderate [3][6] - The most common treatment-emergent adverse events included infusion-related reactions, with a low incidence of anaphylactic reactions (0.6%) [3][12] - The safety profile aligns with previous clinical trials for COVID-19 monoclonal antibodies [3][6] Group 3: Regulatory and Future Implications - The trial's results support the emergency use authorization (EUA) of PEMGARDA (pemivibart) for pre-exposure prophylaxis in certain immunocompromised patients [2][10] - The publication aims to educate clinicians on the potential of monoclonal antibodies in combating COVID-19, particularly for immunocompromised individuals [5][7] - Invivyd plans to leverage data from the CANOPY trial to expedite the approval of novel antibodies like VYD2311 [7][18]

WALTHAM, Mass., May 23, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), today announced that PEMGARDA® (pemivibart), its investigational monoclonal antibody, has been added to the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for B-Cell Lymphomas. NCCN joins the Infectious Disease Society of America (IDSA) that updated its COVID-19 guidelines in August 2024 to recommend the use of PEMGARDA (pemivibart) for pre-exposure prophylaxis (PrEP) in moderately to seve ...

FDA acknowledges that the benefit of repeat doses of COVID-19 vaccine boosters for Americans is uncertain; the updated regulatory framework for COVID-19 vaccines articulated by the Agency generally aligns with recent Invivyd Citizen Petition requestsIn contrast to vaccine boosters, monoclonal antibody (mAb) therapies, including pemivibart, underwent contemporary randomized, placebo-controlled trials to evaluate safety, immunogenicity, and exploratory efficacy in relevant, modern Americans, against relevant, ...

Invivyd (IVVD) Q1 2025 Earnings Call May 15, 2025 08:30 AM ET Company Participants Katie Falzone - SVP - FinanceMarc Elia - Chairperson of the BoardTimothy Lee - Chief Commercial OfficerRobert Allen - Chief Scientific OfficerMark Wingertzahn - Senior Vice President of Clinical Development & Medical AffairsWilliam Duke - Chief Financial OfficerKyle Yang - Senior AssociateLuis Santos - Senior Equity Research Associate, Healthcare & Biotechnology Operator Thank you for standing by, and welcome to Nvivit's Firs ...

Invivyd (IVVD) Q1 2025 Earnings Call May 15, 2025 08:30 AM ET Speaker0 Thank you for standing by, and welcome to Nvivit's First Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press 11 on your telephone. To remove yourself from the queue, you may press 11 again. I would now like to hand the call over to Katie Bozzon ...

INVIVYD Q1 2025 FINANCIAL RESULTS & BUSINESS HIGHLIGHTS May 15, 2025 © 2025 Invivyd, Inc. Invivyd , Pemgarda , and the Ribbon logos are trademarks of Invivyd, Inc. All trademarks in this presentation are the property of their respective owners. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements in this presentation that are not statements of historical fact are ...

PEMGARDA™ (pemivibart) net product revenue of $11.3 million reported for Q1 2025, influenced by planned transition (Jan/Feb) from a contracted to an internalized sales forcePEMGARDA revenue re-acceleration observed in Q2 2025 to dateInvivyd continues to target near-term profitability (1H 2025) with existing cash and cash equivalents, anticipated growth of net product revenue, and continued reduction of operating expensesSince Emergency Use Authorization (EUA) of PEMGARDA in March 2024, no documented cases o ...