The DECLARATION (safety and efficacy vs. placebo) and LIBERTY (exploratory safety head-to-head and combination with mRNA-based COVID vaccination) clinical trials are expected to begin around year-end 2025; top-line data anticipated mid-2026DECLARATION is a Phase 3, randomized, placebo-controlled clinical trial to evaluate prevention of COVID, at three months, from a single intramuscular (IM) dose of VYD2311, with longer-term protection anticipated. A second VYD2311 arm will evaluate monthly IM doses to demo ...

NEW HAVEN, Conn., Sept. 24, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (NASDAQ: IVVD) today announced the appointment of Paul B. Bolno, M.D., to its Board of Directors and as a member of the Compensation Committee. Dr. Bolno is the President and CEO of Wave Life Sciences, a clinical-stage biotechnology company, and has served in those roles since 2013. “We are happy to have Dr. Bolno join our Board at this critical moment while we transition toward a future focused on helping large populations avoid becoming il ...

In this article, we will be taking a look at the 15 Best Biotech Penny Stocks to Invest in Right Now. Invivyd, Inc. stands among them. Invivyd, Inc. (NASDAQ:IVVD) is a commercial-stage biopharmaceutical company focused on developing antibody-based therapies for serious viral infections, including COVID-19 and influenza. Its INVYMAB platform combines viral surveillance, predictive modeling, and advanced antibody engineering to deliver next-generation monoclonal antibody (mAb) solutions. Recently, Invivyd, ...

NEW HAVEN, Conn., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced the appointment of Kristie Kuhl as Chief Communications Officer. Ms. Kuhl will lead the Company’s communications and patient advocacy efforts as Invivyd advances its mission of providing monoclonal antibodies for the prevention and treatment of viral disease. Ms. Kuhl brings deep expertise in healthcare and pharmaceutical communications, and she has been recognized by industry media for her influence in health ...

Summary of Invivyd Conference Call Company Overview - **Company Name**: Invivyd - **Industry**: Biopharmaceuticals - **Focus**: Protection from serious viral infectious diseases, starting with SARS-CoV-2 - **Key Product**: PEMGARDA, a monoclonal antibody authorized for COVID-19 prevention in immunocompromised patients since spring 2024 [4][10] Core Points and Arguments - **PEMGARDA**: - Provides a unique alternative for immunocompromised individuals who do not receive adequate protection from vaccines [4] - Administered via a one-hour IV infusion, with a two-hour follow-up [4] - Demonstrated strong efficacy against various COVID-19 strains, maintaining activity where other products have failed [6] - Last quarter revenue reached $11.8 million, a significant increase from $2.3 million in the prior year [14] - **Next-Generation Antibody (VYD-2311)**: - Aims to improve upon PEMGARDA with a longer half-life and potential for intramuscular delivery, enhancing patient access [4][5][20] - Demonstrated a 76-day half-life for IM dosing and a 17-fold improvement in potency over PEMGARDA [21][22] - Expected to facilitate easier administration compared to IV infusion, potentially allowing for pharmacy distribution [7][20] - **Regulatory Environment**: - Improved relations with the FDA following a change in administration and leadership, facilitating a smoother path towards full approval for VYD-2311 [9] - Plans for a pivotal Phase 2/3 trial to support the Biologics License Application (BLA) [24] - **Market Opportunity**: - Anticipates increased demand for PEMGARDA and VYD-2311, especially with rising COVID-19 cases in certain regions [17][18] - Inclusion in treatment guidelines is crucial for physician adoption and payer engagement [16] Additional Important Content - **Future Development**: - Exploring additional applications for monoclonal antibodies, including programs for RSV and measles [12][29] - Aiming to position VYD-2311 for both prevention and potential treatment of COVID-19 [28] - **Financial Position**: - Recently raised $57.5 million to support ongoing commercialization and development efforts [39] - Focused on achieving cash flow breakeven through increased sales and cost mitigation strategies [39] - **Long-Term Vision**: - Invivyd aims to expand beyond COVID-19, targeting multiple disease states with its monoclonal antibody platform [41] This summary encapsulates the key insights from the conference call, highlighting Invivyd's current position, product offerings, regulatory strategies, and future growth potential.

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].

Summary of Invivyd (IVVD) Conference Call - September 03, 2025 Company Overview - **Company**: Invivyd (IVVD) - **Product**: PEMGARDA, a monoclonal antibody authorized under Emergency Use Authorization for the prevention of COVID-19 in certain immunocompromised individuals [2][4] Core Points and Arguments 1. **Current Status**: Invivyd is a commercial-stage company with an authorized product, PEMGARDA, and is developing a next-generation monoclonal antibody, VYD2311, aimed at improving efficacy and safety compared to existing vaccines [2][3][4] 2. **Technological Advantage**: The company emphasizes its unique technology that allows for the evolution of antibodies to enhance their biophysical properties, which is expected to lead to better medical outcomes for patients [3][4] 3. **Regulatory Engagement**: Invivyd has had constructive dialogues with the FDA regarding the development of VYD2311, which is positioned as a potential alternative to vaccines for COVID-19 [4][5][22] 4. **Market Positioning**: The company aims to shift the reliance from vaccines to monoclonal antibodies for COVID-19 prevention, targeting both high-risk adults and pediatric populations [5][14] 5. **Clinical Efficacy**: PEMGARDA has shown an 85% to 94% reduction in the likelihood of getting sick, although it is described as a specialty medicine with logistical challenges for administration [8][10] 6. **Future Development**: The company plans to conduct clinical trials for VYD2311, which is expected to have a favorable product profile compared to vaccines, including higher efficacy, safety, and durability [24][25][39] 7. **Commercial Strategy**: Invivyd is focused on education and engagement with key opinion leaders and decision-makers to prepare for the commercialization of VYD2311 [40][41] 8. **Cost Structure**: The expected cost of goods sold (COGS) for VYD2311 is projected to be below $100, with a retail price potentially around several hundred dollars, aiming to provide a broad population medicine rather than a specialty product [44][45][46] Important but Overlooked Content 1. **Regulatory History**: The regulatory journey of PEMGARDA has been complex, with the FDA and EMA initially defining its role narrowly, which has impacted its market penetration [7][10] 2. **Public Perception**: The company acknowledges the challenges posed by public perception and misinformation regarding COVID-19 treatments and vaccines, emphasizing the need for clear communication of the benefits of monoclonal antibodies [28][30] 3. **Potential for Resistance**: Invivyd is aware of the potential for emerging resistance to antibodies but believes that their current product, VYD2311, will maintain efficacy due to its stable epitope [47][48] This summary encapsulates the key points discussed during the conference call, highlighting Invivyd's strategic direction, product development, and market positioning in the context of COVID-19 treatment.

Core Insights - Invivyd (NASDAQ: IVVD) is gaining attention due to its monoclonal antibody candidate as an alternative to traditional COVID-19 vaccines, with shares rising 73% to $0.97 after closing at $0.56 [1][3] - The company's proprietary INVYMAB platform utilizes viral surveillance, predictive modeling, and advanced antibody engineering to develop next-generation therapies, starting with SARS-CoV-2 [3] - A recent $58 million financing round led by RA Capital and Janus Henderson has bolstered investor confidence in Invivyd's long-term development [4] Market Context - The stock price surge coincides with reports of a potential U.S. policy shift regarding reduced support for traditional COVID-19 vaccines, increasing interest in alternatives like Invivyd's approach [5] - Previous significant stock movement occurred in February, where shares spiked nearly 193% following positive safety and pharmacokinetic data [5]

Core Viewpoint - Invivyd, Inc. has successfully closed a public offering of 89,234,480 shares of common stock, raising approximately $57.5 million in gross proceeds before expenses [1][3]. Group 1: Offering Details - The offering included the full exercise of an underwriter's option to purchase an additional 14,423,076 shares at a public offering price of $0.52 per share [1]. - Pre-funded warrants to purchase 21,342,442 shares were also included, priced at $0.5199 each, which reflects the common stock price minus a nominal exercise price [1]. - Cantor Fitzgerald acted as the sole book-running manager for the offering, with RA Capital Management and Janus Henderson Investors leading the financing [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for trial protocol development and advancement of the VYD2311 clinical program [3]. - Funds will also support research and development for pipeline programs targeting respiratory syncytial virus (RSV) and measles, as well as efforts related to monoclonal antibody therapy for Long COVID and COVID-19 Post-Vaccination Syndrome [3]. - Additional uses include working capital and other general corporate purposes [3]. Group 3: Company Background - Invivyd, Inc. is a biopharmaceutical company focused on providing protection against serious viral infectious diseases, starting with SARS-CoV-2 [7]. - The company employs a proprietary integrated technology platform designed to develop and adapt high-quality antibodies [7]. - In March 2024, Invivyd received emergency use authorization from the U.S. FDA for a monoclonal antibody in its innovative pipeline [7].

Core Viewpoint - The biopharmaceutical company Invivyd (IVVD) experienced a significant stock price drop of 18% following the announcement of a $50 million securities offering aimed at funding clinical projects, including research on monoclonal antibody therapies for long COVID [1] Group 1 - Invivyd's stock price fell by 18% in early trading on Thursday [1] - The company announced a securities offering to raise $50 million [1] - The funds will be used to support clinical projects, specifically research on monoclonal antibody therapies for long COVID [1]