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.
About Invivyd, Inc. (Nasdaq: IVVD)
Invivyd, Inc. is a clinical-stage biopharmaceutical company dedicated to delivering innovative solutions to combat serious viral infectious diseases, starting with SARS-CoV-2. Leveraging its proprietary INVYMAB™ platform, the company integrates state-of-the-art viral surveillance, predictive modeling, and advanced antibody engineering to rapidly generate monoclonal antibodies (mAbs) that address evolving viral threats. This approach allows Invivyd to design and adapt antibodies with enhanced potency, durability, and broader coverage against viral variants.
Core Business and Products
Invivyd's flagship product, PEMGARDA™ (pemivibart), is a half-life extended investigational monoclonal antibody authorized by the U.S. Food and Drug Administration (FDA) for emergency use in the pre-exposure prophylaxis (PrEP) of COVID-19 in certain immunocompromised patients. Engineered from the investigational mAb adintrevimab, PEMGARDA has demonstrated neutralizing activity against major SARS-CoV-2 variants, including JN.1, KP.3.1.1, and XEC, by targeting the spike protein receptor binding domain (RBD) to inhibit viral attachment to human cells.
The company is also advancing VYD2311, a next-generation mAb designed for superior potency and broader coverage. VYD2311 offers the potential for more patient-friendly administration routes, including intramuscular (IM) and subcutaneous (SC) injections, and aims to serve as both a prophylactic and therapeutic option for COVID-19. With a pharmacokinetic profile supporting long-lasting protection, VYD2311 is positioned as a scalable alternative to traditional vaccines and therapies.
Technological Edge
Invivyd's competitive advantage lies in its INVYMAB™ platform, which enables the rapid, serial development of mAbs optimized for evolving viral landscapes. By employing predictive modeling and directed molecular evolution, the platform ensures that antibodies maintain efficacy against contemporary and future variants. This capability positions Invivyd as a leader in the development of evolution-resistant and durable mAbs for pandemic preparedness.
Market Significance and Unmet Needs
Invivyd addresses critical gaps in protection for vulnerable populations, particularly immunocompromised individuals who may not respond adequately to vaccines. With millions of such individuals in the U.S. alone, the company's products provide a vital option for pre-exposure prophylaxis and treatment. The ongoing development of VYD2311 further expands Invivyd's potential to serve broader populations, including those seeking long-term protection and convenient administration.
Challenges and Opportunities
While Invivyd faces challenges such as regulatory scrutiny, manufacturing complexities, and competition from other biopharmaceutical companies, its focus on innovation and adaptability sets it apart. The company's commitment to addressing unmet medical needs through advanced antibody engineering positions it as a key player in the fight against viral infectious diseases.
Conclusion
Invivyd, Inc. exemplifies a forward-thinking approach to biopharmaceutical innovation, combining cutting-edge technology with a mission to protect vulnerable populations from serious viral threats. Through its robust pipeline and strategic focus on long-acting, evolution-resistant antibodies, Invivyd is poised to make a significant impact on global health.
Invivyd (IVVD) announces continued neutralizing activity of PEMGARDA™ (pemivibart) against dominant SARS-CoV-2 variants KP.3.1.1 and LB.1, as well as other variants of interest. New pseudovirus in vitro neutralization data show:
1. Continued effectiveness against KP.3.1.1, which accounts for 42.2% of circulating variants and is the only major variant increasing nationally.
2. Efficacy against variants containing key mutations like Q493E and S31 deletion.
3. Pemivibart's epitope remains intact across 99.59% of viral sequences since Omicron BA.1.
4. Pipeline candidate VYD2311 also shows promising neutralization potency.
Data submitted to FDA for potential updates to PEMGARDA™ Fact Sheet. This demonstrates Invivyd's ongoing efforts in developing variation-resistant COVID-19 antibody medicines.
Invivyd (Nasdaq: IVVD) announced positive 180-day exploratory clinical efficacy data from its ongoing CANOPY Phase 3 trial of pemivibart, an investigational monoclonal antibody for COVID-19 pre-exposure prophylaxis. In immunocompetent individuals, pemivibart demonstrated an 84% relative risk reduction in symptomatic COVID-19 compared to placebo. The pemivibart group had a 1.9% rate of confirmed symptomatic COVID-19, versus 11.9% in the placebo group. In immunocompromised participants, pemivibart showed a 3% rate of confirmed symptomatic COVID-19. The safety profile remained consistent with previous data. The FDA updated the PEMGARDA Fact Sheet for Healthcare Providers to include these exploratory clinical efficacy data.
Invivyd reported Q2 2024 financial results and business highlights for its COVID-19 antibody PEMGARDA. Key points include:
1. $2.3 million net product revenue from PEMGARDA's commercial launch
2. Accelerating commercial results in early Q3 2024
3. New Chief Commercial Officer, Tim Lee, appointed
4. Achieved Medicare, Medicaid, and commercial insurance coverage
5. Submitted EUA amendment for PEMGARDA treatment of mild-to-moderate COVID-19 in immunocompromised patients
6. VYD2311 first-in-human trial to begin in late August
7. $147.9 million in cash and cash equivalents at Q2 end
8. Projected 2024 year-end cash of at least $75 million
9. Anticipated 2024 net product revenue of $150-$200 million
Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company focused on protecting against serious viral infectious diseases, has announced a conference call scheduled for Wednesday, August 14, 2024, at 8:30 a.m. ET. The call will cover the company's financial results for the second quarter ended June 30, 2024, along with recent business highlights. Interested parties can register for the webcast through a provided link, while analysts who wish to participate in the Q&A session have a separate link available. A replay of the webcast will be accessible on Invivyd's investor website approximately two hours after the call concludes. Participants are advised to join 15 minutes before the start time.
Invivyd (Nasdaq: IVVD), a biopharmaceutical company, announced its inclusion in the Russell 2000® and Russell 3000® Indexes following the annual reconstitution. This is effective from today, July 1, 2024, at the opening of U.S. equity markets. Being part of the Russell 3000® Index means automatic inclusion in the large-cap Russell 1000® or small-cap Russell 2000® Index and relevant growth and value style indexes. The Russell 3000® Index includes the 3,000 largest U.S.-traded stocks based on market capitalization and style attributes. Membership in these indexes is reviewed annually and helps investment managers and institutional investors benchmark active investment strategies and manage index funds. The Russell indexes are maintained by FTSE Russell, a leading global index provider.
Invivyd announced that its investigational monoclonal antibody, VYD222 (pemivibart), shows continued in vitro neutralizing activity against the current dominant SARS-CoV-2 variants, KP.1.1 FLiRT and KP.3.
This data aligns with earlier findings from an independent lab. The next candidate, VYD2311, also shows similar neutralization activity. As of June 8, 2024, FLiRT variants account for over 50% of circulating SARS-CoV-2 sequences, with KP.3 expected to become the most dominant strain.
Invivyd uses proprietary software, VivydTools, to track and monitor virus variations. The company notes the stability of the VYD222 epitope and is committed to ongoing assessment.
Invivyd (Nasdaq: IVVD), a biopharmaceutical company focused on viral infectious diseases, announced its participation in the Jefferies Global Healthcare Conference on June 6, 2024, at 3:00 p.m. ET in New York. The company will engage in a fireside chat and host investor meetings. A live webcast of the chat will be available on Invivyd's investor website and archived for 30 days.
Invivyd has aligned with the U.S. FDA on a streamlined, repeatable pathway for emergency use authorization (EUA) for new monoclonal antibodies (mAbs) aimed at preventing and treating symptomatic COVID-19. This new approach allows for a master clinical trial protocol, simplifying the evaluation process and potentially reducing costs and time. Invivyd plans to quickly advance to a registrational trial for VYD2311, assessing intravenous and other delivery methods. The estimated cost for the safety and pharmacokinetics data is $25-40 million. This pathway is designed to keep pace with the rapid evolution of SARS-CoV-2, providing a reliable route for delivering high-value treatments.
Invivyd has appointed Timothy Lee as Chief Commercial Officer, effective immediately. Mr. Lee brings extensive experience from his previous roles at Alexion, Biohaven, and Amylyx, where he led successful product launches and significant revenue growth. This move is aimed at enhancing Invivyd's commercial capabilities, particularly for the ongoing launch of PEMGARDA™, a commercial phase asset targeting COVID-19 in vulnerable populations. Concurrently, William Duke, Jr., Invivyd's CFO, will assume the role of Principal Executive Officer during the transitional period while the search for a permanent CEO continues. The reallocation of resources has led to the elimination of the Chief Operating Officer role and the departure of Jeremy Gowler. The leadership believes Mr. Lee's track record in driving sales growth makes him well-suited to accelerate Invivyd's growth trajectory.
Invivyd announced its upcoming presentations at the 2024 ASCO Annual Meeting and the 2024 ATC. The presentations will cover preliminary subset analyses from the Phase 3 CANOPY trial of VYD222 (pemivibart), a monoclonal antibody aimed at preventing COVID-19.
At ASCO (May 31 – June 4, Chicago, IL), the focus will be on participants with significant immune compromise due to solid tumor or hematologic malignancies (Abstract# 2532). The poster presentation is scheduled for June 1 from 9 AM – 12 PM CDT.
At ATC (June 1 – June 5, Philadelphia, PA), the preliminary results for solid organ transplant patients will be discussed (Abstract #A018). The poster presentation is set for June 1 from 5:30 PM – 7 PM EST.
Posters will be available on the Invivyd website after the meetings.
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