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 biopharmaceutical company focused on monoclonal antibody therapies for serious viral infectious diseases, beginning with SARS-CoV-2. The Invivyd news feed on Stock Titan highlights company announcements about clinical development, regulatory milestones, commercial performance, financing activities, and pipeline expansion.
Recent Invivyd news has featured updates on PEMGARDA (pemivibart), the company’s investigational monoclonal antibody authorized under a U.S. FDA emergency use authorization for pre-exposure prophylaxis of COVID-19 in certain immunocompromised adults and adolescents. The company reports quarterly PEMGARDA net product revenue and discusses uptake among healthcare providers caring for immunocompromised patients.
Investors also see frequent coverage of VYD2311, Invivyd’s vaccine-alternative monoclonal antibody candidate for COVID-19. News items describe FDA Fast Track designation, U.S. IND clearance, and the design of the Phase 3 DECLARATION trial within the broader REVOLUTION clinical program. Articles outline trial endpoints, intramuscular dosing regimens, and plans for pivotal data to support a potential Biologics License Application.
Beyond COVID-19, Invivyd’s news flow includes pipeline developments such as the selection of VBY329, a monoclonal antibody candidate for prevention of RSV infections in neonates, infants, and children, and discovery efforts targeting measles and other infectious diseases. Corporate news covers public offerings of common stock and pre-funded warrants, participation in healthcare conferences, and formation of the SPEAR Study Group to evaluate monoclonal antibody therapy for Long COVID and COVID-19 post-vaccination syndrome.
By following the IVVD news page, readers can review Invivyd’s official press releases and related updates in one place, including earnings announcements, clinical trial progress, regulatory designations, and capital-raising transactions.
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.
Invivyd, a biopharmaceutical firm, has announced the election of Dr. Srishti Gupta and Kevin F. McLaughlin as independent directors to its Board. Dr. Gupta will chair the Compensation Committee, while Mr. McLaughlin will chair the Audit Committee. This development follows Invivyd's focus on growth and product commercialization, particularly in combating viral diseases such as SARS-CoV-2. The company has received emergency use authorization from the U.S. FDA for pre-exposure prophylaxis of COVID-19 in immunocompromised individuals and is considering further authorizations for treatment. The board now comprises seven directors.
Invivyd (Nasdaq: IVVD), a biopharmaceutical company specializing in protection against serious viral infectious diseases, announced that Marc Elia, Chairman of Invivyd's Board, will present at the H.C. Wainwright 2nd Annual BioConnect Investor Conference. The presentation is scheduled for Monday, May 20, 2024, at 3:00 p.m. ET in New York, NY. Alongside the fireside chat, Invivyd's management team will hold investor meetings. Interested investors can contact their H.C. Wainwright representative for meeting arrangements. The fireside chat will be webcast live on Invivyd's investor relations website and archived for 30 days.