Welcome to our dedicated page for Invivyd news (Ticker: IVVD), a resource for investors and traders seeking the latest updates and insights on Invivyd stock.
Invivyd, Inc. (Nasdaq: IVVD) is a clinical-stage biopharmaceutical company committed to the innovation, development, and commercialization of antibody-based therapies aimed at combating infectious diseases with pandemic potential. The company is primarily focused on developing antibodies that can provide superior protection against viral threats, starting with COVID-19.
Invivyd’s lead program, ADG20, is in clinical stages for both treatment and prevention of COVID-19, showcasing a broad spectrum of activity against various SARS-CoV-2 variants. Another promising candidate, VYD222, is engineered to ensure high potency and prolonged action in an evolving viral landscape. These efforts reflect Invivyd’s strategic approach of leveraging best-in-class antibody discovery capabilities to create multiple, non-competing antibodies with distinct targets, thereby minimizing the risk of viral escape.
In recent developments, Invivyd has achieved notable milestones including the receipt of Emergency Use Authorization (EUA) for PEMGARDA™ (pemivibart) for the pre-exposure prophylaxis of COVID-19 in moderately to severely immunocompromised individuals. PEMGARDA is the first mAb to receive EUA utilizing a rapid immunobridging trial design, indicating its potential to meet urgent medical needs. The company is positioned to launch PEMGARDA in the U.S., targeting key healthcare practitioners and institutions caring for high-risk populations.
The company’s proprietary INVYMAB™ platform integrates advanced viral surveillance, predictive modeling, and antibody engineering to generate new monoclonal antibodies (mAbs) swiftly and serially. This approach ensures that Invivyd remains at the forefront of addressing evolving viral threats. In addition to PEMGARDA, Invivyd is planning to advance VYD2311 into clinical development, further expanding its innovative pipeline.
Financially, Invivyd has projected a robust performance with net product revenue guidance for PEMGARDA ranging from $150 million to $200 million for the full year 2024. The company’s recent strategic review has optimized operational efficiencies, improving the projected year-end cash position to at least $75 million. These financial strategies ensure that Invivyd is well-positioned to sustain its development efforts and commercial initiatives.
Looking ahead, Invivyd plans to seek authorization for PEMGARDA for the treatment of mild to moderate symptomatic COVID-19 in immunocompromised individuals using an aligned, rapid immunobridging pathway. This underscores the company’s mission to deliver effective antibody-based treatments that continually adapt to the changing viral landscape.
Overall, Invivyd, Inc. exemplifies a relentless commitment to protecting vulnerable populations from serious viral infections through pioneering therapeutic advancements and strategic financial stewardship.
Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company, announced that CEO David Hering will present at H.C. Wainwright's BioConnect Investor Conference on May 2, 2023, at 4:00 p.m. ET, held at Nasdaq World Headquarters in New York. The presentation aims to discuss Invivyd's mission of delivering antibody-based therapies to protect vulnerable populations from viral infectious diseases, particularly SARS-CoV-2. A live webcast of the presentation will be accessible on the company's investor website and archived for 90 days post-event.
Invivyd is focused on developing a pipeline of high-quality, long-lasting antibodies to combat serious viral threats, starting with COVID-19 and extending to influenza and other significant diseases. For more information, visit invivyd.com.
Invivyd, Inc. (Nasdaq: IVVD) announced the FDA's clearance of its IND application for VYD222, a monoclonal antibody candidate aimed at preventing COVID-19 in vulnerable populations. The ongoing Phase 1 trial in Australia has completed dosing of the first cohort, moving to the second cohort, with initial readouts expected in Q2 2023. This trial is designed to evaluate safety, tolerability, and neutralizing activity against emerging variants. VYD222 is targeted at immunocompromised individuals who may not respond adequately to COVID-19 vaccines. The drug has shown in vitro neutralizing activity against the XBB.1.5 variant. Regulatory discussions are also underway for the pivotal trial design.
Invivyd, Inc. (Nasdaq: IVVD) announced the appointment of Robert Allen as chief scientific officer and Stacy Price as chief technology and manufacturing officer. Dr. Allen, with over 30 years of experience in infectious diseases, will lead the company's scientific direction and help develop therapies across Invivyd's pipeline, particularly focusing on antibodies for COVID-19 variants. Stacy Price, who joined Invivyd in March 2023, brings extensive biotechnology operations experience and will enhance the company's chemistry, manufacturing, and controls programs. Invivyd aims to deliver antibody-based therapies to protect vulnerable populations from serious viral diseases, including COVID-19 and influenza. CEO David Hering emphasized the strategic importance of these appointments for strengthening Invivyd's capabilities and advancing its product candidates.
Invivyd, Inc. (Nasdaq: IVVD) announced the initiation of a Phase 1 clinical trial for its monoclonal antibody candidate, VYD222, aimed at addressing COVID-19 in vulnerable populations. This randomized, placebo-controlled trial, featuring three IV infusion doses, will assess safety and pharmacokinetics. Preliminary data is expected in Q2 2023, with further clinical insights anticipated throughout the year. The trial is crucial as current authorized treatments show reduced efficacy against emerging SARS-CoV-2 variants. VYD222 has demonstrated in vitro activity against variants like XBB.1.5, providing hope for immunocompromised individuals who may not respond adequately to vaccination.
Invivyd, Inc. (Nasdaq: IVVD) announced it is advancing VYD222 into clinical development, demonstrating neutralizing activity against key COVID-19 variants. In 2022, the company reported a net loss of $241.3 million and expects its cash reserves of $372 million to support operations into the second half of 2024. The focus on VYD222 aims to fulfill the urgent need for effective therapies for vulnerable populations. This follows a strategic pivot to monoclonal antibody candidates as regulatory landscapes evolve. A conference call scheduled for March 23, 2023, will further detail these developments.
Invivyd, Inc. (Nasdaq: IVVD) announces the publication of research in Science Translational Medicine, detailing a model for evaluating monoclonal antibody (mAb) efficacy against symptomatic COVID-19. The Phase 2/3 study of adintrevimab indicates that low neutralizing antibody titers can provide clinically meaningful protection. This work is expected to influence regulatory frameworks for mAbs, potentially expediting development processes. The study identifies a protective titer threshold of 1:30, with higher levels enhancing protection. Invivyd plans to advance its candidate VYD222 into clinical trials soon, aiming to address evolving variants.
Invivyd, Inc. (Nasdaq: IVVD) announced a conference call scheduled for March 23, 2023, at 4:30 p.m. ET. The call will discuss its financial results for the year ended December 31, 2022, alongside recent business highlights. Invivyd is focused on developing antibody-based therapies targeting serious viral threats, notably SARS-CoV-2. The company employs advanced techniques in evolutionary virology and antibody engineering to create long-lasting antibodies to counteract viral escape. Investors and analysts can register for the call and access a replay via the company's investor website.
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