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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) announced the election of its monoclonal antibody candidate VYD222 for clinical advancement as a therapeutic option for COVID-19, particularly targeting immunocompromised individuals. The company aims to leverage emerging global regulatory frameworks to expedite development. Currently, no monoclonal antibodies are authorized in the U.S. for COVID-19 prevention or treatment. VYD222, engineered from the investigational adintrevimab, has shown in vitro neutralizing activity against dominant variants, including XBB.1.5. A Phase 1 clinical trial is planned for Q1 2023.
On February 28, 2023, Invivyd, a clinical-stage biopharmaceutical company listed on Nasdaq under the ticker IVVD, announced that CEO David Hering will present at Cowen's 43rd Annual Healthcare Conference on March 6, 2023, at 2:10 p.m. ET. The presentation will be available as a live webcast and archived for 90 days on the company’s investor website. Invivyd focuses on combating viral respiratory diseases through innovative antibody development, particularly targeting COVID-19. The company aims to enhance natural immunity to provide superior viral protection.
Invivyd, Inc. (Nasdaq: IVVD) announced the departure of its Chief Scientific Officer, Laura Walker, Ph.D., who is leaving to pursue other opportunities. Lukas Dillinger, Ph.D., has been appointed interim Head of Discovery and Pre-Clinical during the search for a replacement. CEO David Hering expressed gratitude for Walker's contributions, which were essential in establishing the company's pipeline of antibody candidates against SARS-CoV-2. Invivyd focuses on developing antibodies for serious infectious diseases, particularly COVID-19, with ongoing efforts to advance its pipeline of antibody therapies.
Invivyd, Inc. (Nasdaq: IVVD) participated in an FDA-EMA workshop on December 15, 2022, focusing on SARS-CoV-2 monoclonal antibodies. The company's chief scientific officer, Laura Walker, Ph.D., presented alongside industry leaders to discuss strategies for accelerating antibody development amid evolving variants. The presentation underscored the unmet medical need for COVID-19 therapies and proposed data-driven policy changes to optimize development timelines. Invivyd's antibody technologies aim to provide superior protection against viral diseases, including COVID-19.
Invivyd, Inc. (Nasdaq: IVVD) has announced key management changes effective December 16, 2022. Jeremy Gowler has been appointed as the Chief Operating and Commercial Officer, bringing 20 years of biopharma experience, including leadership at Sandoz. Additionally, Pete Schmidt, previously Vice President of Clinical Research, has been promoted to Chief Medical Officer. The company aims to advance its monoclonal antibodies pipeline for COVID-19 and other respiratory diseases while streamlining operations following Dr. Ellie Hershberger's departure, who will provide consulting services.
Invivyd, a clinical-stage biopharmaceutical company (Nasdaq: IVVD), has announced a strategic partnership with Population Health Partners (PHP) aimed at improving the efficiency of its NVD200 clinical program and developing engineered antibodies for COVID-19. This collaboration will leverage PHP's expertise in clinical development and regulatory strategies, aligning Invivyd's capabilities with the evolving SARS-CoV-2 landscape.
Invivyd's NVD200 candidate, integrating adintrevimab, is set to enter clinical trials in Q1 2023, addressing the urgent need for effective treatments amid dwindling antibody effectiveness against emerging variants.
Invivyd (Nasdaq: IVVD) announced its third-quarter 2022 results, highlighting a cash position of $419 million, expected to fund operations into Q2 2024. The company aims to advance its monoclonal antibody candidate, NVD200, into clinical trials in Q1 2023. During the quarter, R&D expenses decreased to $34.1 million from $49.4 million in 2021, while SG&A expenses rose to $13.2 million. The net loss narrowed to $45.1 million from $60.4 million year-over-year, with a per-share loss of $0.42. A conference call is scheduled for November 10 at 4:30 p.m. ET.
Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical firm, announced that CEO David Hering will participate in a fireside chat at the Jefferies London Healthcare Conference on November 15, 2022, at 4:25 p.m. GMT. The event will be accessible via a live webcast on the investor section of Invivyd’s website, with an archive available for 90 days post-presentation.
Invivyd focuses on developing antibodies to enhance immunity against serious viral respiratory diseases, including COVID-19. Its first candidate, NVD200, aims to prevent and treat COVID-19 using advanced antibody technology.
Invivyd, a clinical-stage biopharmaceutical company, announced a conference call to discuss its Q3 financial results on November 10, 2022, at 4:30 p.m. ET. The earnings report will cover the period ending September 30, 2022, alongside recent business highlights. Invivyd focuses on developing antibodies to combat viral respiratory diseases, notably COVID-19, with its candidate NVD200 showing promise. The company aims to enhance immunity against evolving viral threats. Analysts can join the Q&A session after the call.
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