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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.
Invivyd, Inc. (Nasdaq: IVVD) reported strong financial results for Q1 2024, ending with $189.4 million in cash. The company expects to end 2024 with at least $75 million in cash, based on projected revenue of $150-$200 million. Key highlights include the launch of PEMGARDA™ for COVID-19 pre-exposure prophylaxis, receipt of reimbursement codes, and advancing VYD2311, a new monoclonal antibody candidate. Invivyd also announced plans to pursue EUA for COVID-19 treatment and shared interim clinical data from the CANOPY Phase 3 trial.
Invivyd, Inc. announced plans to seek EUA for COVID-19 treatment in immunocompromised individuals through a rapid immunobridging pathway leveraging prior successful clinical trials. The company intends to submit an application for pemivibart imminently, aiming for a potential second EUA. Despite this, 2024 revenue and cash guidance remain unchanged. The company will provide more details during the upcoming 1Q 2024 results call on May 9, 2024.
Invivyd, Inc. (Nasdaq: IVVD) will host a conference call on May 9, 2024, to discuss its first-quarter financial results and recent business highlights. The company focuses on protection from viral infectious diseases.
Invivyd, Inc. (Nasdaq: IVVD) has announced a significant improvement in its projected 2024 year-end cash position by $20-25 million, expecting to end the year with at least $75 million in cash and cash equivalents. The company achieved these improvements through resource realignment to focus on the commercial launch of PEMGARDA™ and the discovery of novel monoclonal antibodies. Despite eliminating fourteen full-time positions, Invivyd remains positive about its 2024 revenue projections.
