Core Viewpoint - The FDA has declined Invivyd, Inc.'s request to expand the emergency use authorization for its COVID-19 treatment Pemgarda, which remains authorized only for certain immunocompromised patients [1][3]. Group 1: FDA Decision - The FDA's reasoning for declining the request is based on the belief that immunobridging analyses for monoclonal antibodies must demonstrate superior antiviral activity compared to previously authorized COVID-19 mAbs [3]. - The existing emergency use authorization for Pemgarda for pre-exposure prophylaxis in specific immunocompromised patients is still in effect [1]. Group 2: Financial Implications - The company indicated that the COVID-19 treatment opportunity for pemivibart was not included in its existing financial guidance [2]. Group 3: Clinical Data and Market Reaction - Invivyd released new data from the ongoing Phase 1/2 trial of VYD2311, showing high serum concentrations that may increase the observed half-life compared to pemivibart [4]. - Following the FDA's decision, Invivyd's stock price fell by 29.9%, trading at $1.24 during the premarket session [4].

Core Insights - Invivyd, Inc. is set to present at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 12, 2025, at 1:20 PM ET [1] - The company focuses on developing protection against serious viral infectious diseases, starting with SARS-CoV-2, utilizing a proprietary integrated technology platform [2] Company Overview - Invivyd, Inc. is a biopharmaceutical company listed on Nasdaq under the ticker IVVD [2] - The company has received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody in its pipeline [2] - Invivyd's technology platform is designed to assess, monitor, develop, and adapt to create best-in-class antibodies [2]

Core Insights - Invivyd, Inc. has formed a strategic partnership with football coach Jim Harbaugh to raise awareness about the ongoing risks of COVID-19, particularly for immunocompromised individuals [1][3][7] - Despite the availability of vaccines and therapies, COVID-19 continues to pose significant health risks, with approximately 59,000 deaths and 665,000 hospitalizations reported in 2024 [2][7] - The long-term impacts of COVID-19 may exceed those of several chronic diseases, creating a substantial burden on healthcare systems and society [2][10] Company Overview - Invivyd, Inc. is a biopharmaceutical company focused on providing protection against serious viral infectious diseases, starting with SARS-CoV-2 [4] - The company utilizes a proprietary technology platform to develop and adapt antibodies, having received emergency use authorization for a monoclonal antibody in March 2024 [4] Health Impact and Statistics - COVID-19 is causing an American death approximately every 9 minutes, highlighting the ongoing severity of the pandemic [2][7] - The percentage of COVID-19 hospitalizations requiring intensive care unit (ICU) admissions is increasing again, indicating a rising health crisis [2] - The 2023-2024 respiratory season saw hospitalizations calculated based on a U.S. population estimate of 334.9 million [6][9]

Company Overview - Invivyd, Inc. is a biotechnology company focused on developing antibody-based treatments for infectious diseases, primarily COVID-19 [1] - The company was established in 2020 and is based in Massachusetts [1] Investment Focus - The mission of Grassroots Trading emphasizes providing objective and unbiased research, particularly on small- to mid-cap companies [1] - The company aims to identify compelling investment opportunities that are often overlooked, while also considering larger companies periodically [1]

Core Insights - Invivyd, Inc. announced positive data from its Phase 1/2 clinical trial of VYD2311, a novel monoclonal antibody designed as an alternative to COVID-19 vaccination and for treatment [1][2][10] Group 1: Clinical Trial Details - The ongoing Phase 1/2 trial involves 40 subjects and evaluates the safety and pharmacokinetic profile of VYD2311 across multiple administration routes: intravenous, intramuscular, and subcutaneous [3][7] - All planned doses have been administered, with only long-term follow-up remaining [3][7] - Adverse events reported so far are mild to moderate, primarily related to injection site reactions [4][7] Group 2: Pharmacokinetics and Efficacy - As of Day 65, serum concentrations of VYD2311 remain high, indicating a potential long clinical dosing interval [5][7] - VYD2311 shows an average 17-fold greater neutralization potency against contemporary SARS-CoV-2 variants compared to pemivibart [8][9] - The clinical profile of VYD2311 suggests stronger protection (70-90%) from symptomatic COVID-19 disease and less frequent dosing [7][9] Group 3: Market Potential and Strategic Vision - The company aims to provide a more effective and convenient option for managing COVID-19, addressing the limitations of current vaccines [10][11] - VYD2311 is positioned as a potential long-acting treatment option, suitable for immunocompromised individuals who may benefit from higher serum virus neutralizing antibody titers [9][10] - The company emphasizes the importance of advancing VYD2311 to populations at highest risk of COVID-19, highlighting the ongoing burden of the disease [10][22]

Core Insights - Invivyd, Inc. announced preliminary financial results for Q4 2024, highlighting significant revenue growth and operational efficiency improvements [1][2][3] Financial Performance - The company reported preliminary Q4 2024 net product revenue of $13.8 million, a 48% increase from Q3 2024's $9.3 million [3][7] - Total operating costs and expenses for Q4 2024 were approximately $32 million, reflecting a 55% reduction compared to Q3 2024's $71.6 million [3][7] - Invivyd ended 2024 with $69.3 million in cash and cash equivalents, along with $10.9 million in outstanding accounts receivable [2][7] Profitability Outlook - The company continues to target near-term profitability by the end of the first half of 2025, leveraging existing cash, anticipated revenue growth, and reduced manufacturing expenses [2][7] Product Information - PEMGARDA™ (pemivibart) is an investigational monoclonal antibody designed for pre-exposure prophylaxis against COVID-19, showing in vitro neutralizing activity against major SARS-CoV-2 variants [4][5][11] - VYD2311 is another monoclonal antibody candidate in development, aimed at providing new prophylactic and therapeutic options for COVID-19 [11][12] Regulatory Status - PEMGARDA has received emergency use authorization (EUA) from the U.S. FDA for specific immunocompromised populations, although it is not authorized for treatment or post-exposure prophylaxis of COVID-19 [5][6][10]

Treatment immunobridging analysis, routinely updated for contemporary SARS-CoV-2 variants, compares pemivibart antiviral titers to adintrevimab antiviral titers from the company’s previous Phase 2/3 clinical trial of adintrevimab for the treatment of COVID-19 (STAMP), in which adintrevimab conferred a 66% to 74% reduction in risk of hospitalization or death from COVID-19 compared to placebo depending on time of therapy startMost recent updated analysis provided to FDA, incorporating current dominant SARS-Co ...

Core Findings - New in vitro neutralization data show continued neutralizing activity of PEMGARDA™ (pemivibart) and pipeline candidate VYD2311 against dominant SARS-CoV-2 variant XEC, consistent with previous data for KP 3 1 1 [1][2] - XEC and KP 3 1 1 accounted for 69% of U S circulating SARS-CoV-2 variants for the two weeks ended December 21, 2024 [1] - PEMGARDA has demonstrated neutralizing activity against over 75% of currently circulating U S variants and all prior variants tested to date [6] - Data submitted to FDA, with timely update to PEMGARDA™ Fact Sheet for Healthcare Providers anticipated [2][7] Product Details - PEMGARDA (pemivibart) is an investigational monoclonal antibody (mAb) authorized for emergency use by the U S FDA for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise [3][11] - PEMGARDA targets the SARS-CoV-2 spike protein receptor binding domain (RBD), inhibiting virus attachment to the human ACE2 receptor on host cells [11] - VYD2311, a novel mAb candidate, is being developed for COVID-19 to address the urgent need for new therapeutic options for vulnerable populations, including immunocompromised individuals [15][16] Research and Development - Invivyd leverages a consistent, high-quality, independent, third-party pseudoviral system for testing pemivibart, supported by extensive structure-based and proprietary analytics [1][9] - The company's INVYMAB™ platform combines viral surveillance, predictive modeling, and advanced antibody engineering to facilitate the rapid, serial generation of new mAbs to address evolving viral threats [17] - Pemivibart has demonstrated antiviral activity in neutralization assays representing 39 distinct SARS-CoV-2 variants across almost three years of rapid virus evolution [10] Market and Industry Context - The emergency use of PEMGARDA is authorized only when the combined national frequency of variants with substantially reduced susceptibility to PEMGARDA is ≤90% [14] - Invivyd received emergency use authorization (EUA) from the U S FDA for PEMGARDA in March 2024, marking its first mAb in a planned series of innovative antibody candidates [17]

Invivyd, Inc. (IVVD) came out with a quarterly loss of $0.51 per share versus the Zacks Consensus Estimate of a loss of $0.33. This compares to loss of $0.36 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -54.55%. A quarter ago, it was expected that this company would post a loss of $0.37 per share when it actually produced a loss of $0.40, delivering a surprise of -8.11%.Over the last four quarters, the company has surpassed ...

Q3 2024 PEMGARDA™ (pemivibart) net product revenue of $9.3 million; Invivyd ended Q3 2024 with $106.9 million in cash and cash equivalentsTargets near-term (1H 2025) profitability with existing cash and cash equivalents, anticipated growth of net product revenue, and various operational efficiency improvementsPEMGARDA Fact Sheet updated to properly reflect neutralization activity of PEMGARDA against current circulating variants tested; on track for continued growth now reflective of ongoing commercial optim ...