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. develops monoclonal antibody therapies for serious viral infectious diseases, with an initial focus on SARS-CoV-2. Company news commonly covers PEMGARDA (pemivibart), which received U.S. FDA emergency use authorization for pre-exposure prevention of COVID-19 in certain immunocompromised individuals, and pipeline work involving VYD2311 for COVID-19, VBY329 for RSV, and VMS063 for measles.
Updates also address clinical-study design and tolerability research, antibody platform presentations, financial results and corporate updates, public education efforts around antibodies and immune health, and Nasdaq inducement equity grants under the company’s 2026 Inducement Plan.
Invivyd (NASDAQ: IVVD) has submitted a Citizen Petition to the FDA advocating for a shift in how COVID-19 preventative treatments are evaluated. The company argues that current vaccine efficacy data needs reassessment due to three key factors: the widespread immunity in the population, the emergence of immune-evasive Omicron variants, and better understanding of vaccine efficacy waning.
The petition urges the FDA to require new clinical trials for COVID-19 vaccines that include: 1) seropositive patients in randomized controlled trials, 2) testing against contemporary Omicron variants, and 3) efficacy measurements over 6+ months. Additionally, Invivyd recommends using serum virus neutralizing antibody (sVNA) titers as a basis for Biologics License Application approval for monoclonal antibodies.
[ "Company is taking proactive steps to influence regulatory framework for COVID-19 treatments", "Petition could potentially streamline approval process for Invivyd's monoclonal antibody treatments", "Company demonstrates scientific leadership in addressing evolving COVID-19 challenges" ]Invivyd (NASDAQ: IVVD) has announced its participation in the H.C. Wainwright 3rd Annual BioConnect Investor Conference. The company's management will engage in a fireside chat on Tuesday, May 20, 2025, at 11:00 a.m. ET in New York. Management will also be available for investor meetings during the conference.
Interested investors attending the conference can arrange meetings through their H.C. Wainwright representative. The fireside chat will be accessible via live webcast on the company's investor relations website at investors.invivyd.com and will remain available for approximately 30 days after the presentation.
Invivyd (NASDAQ: IVVD), a biopharmaceutical company focused on protection against serious viral infectious diseases, has scheduled a conference call for Thursday, May 15, 2025, at 8:30 a.m. ET. The call will cover the company's first quarter 2025 financial results for the period ending March 31, 2025, along with recent business updates.
Analysts interested in participating in the Q&A session should join 15 minutes before the start time. The webcast will be available for replay on Invivyd's investor relations website approximately two hours after the call concludes.
Invivyd (Nasdaq: IVVD) has secured a $30 million term loan facility with Silicon Valley Bank (SVB), a division of First Citizens Bank. The non-dilutive financing agreement allows for future capital drawdown subject to meeting specific conditions and milestones.
The company's CFO Bill Duke highlighted that this facility was secured ahead of important anticipated catalysts, including alignment with the FDA on the regulatory pathway for their pipeline candidate VYD2311. The non-dilutive nature of the financing is aimed at maintaining balance sheet flexibility while focusing on per-share value creation.
Invivyd (Nasdaq: IVVD) has appointed venture capitalist Ajay Royan to its Board of Directors. Royan, founder of Mithril Capital, is a significant long-term stockholder who led the 2022 shareholder action focusing Invivyd on protecting against viral infectious diseases, particularly COVID-19.
The company aims to advance its monoclonal antibody technology platform beyond COVID-19 prevention into more scalable, higher-value medicines. The platform specifically targets vulnerable populations including cancer patients, organ transplant recipients, immunodeficient individuals, and those on immunosuppressive therapies.
Royan emphasizes the need to address endemic diseases affecting vulnerable Americans with the same urgency as Operation Warp Speed, highlighting the limitations of vaccines and the impact of long COVID on these communities.
Invivyd (NASDAQ: IVVD) reported strong Q4 2024 financial results, with PEMGARDA net product revenue reaching $13.8 million, a 48% increase from Q3 2024's $9.3 million. Full-year 2024 revenue totaled $25.4 million.
The company ended 2024 with $69.3 million in cash and expects to achieve profitability by end of 1H 2025. R&D expenses decreased to $137.3 million from $163.6 million in 2023, while SG&A expenses increased to $63.4 million from $49.1 million. Net loss improved to $169.9 million ($1.43 per share) compared to $198.6 million ($1.81 per share) in 2023.
PEMGARDA demonstrated continued neutralizing activity against dominant SARS-CoV-2 variants. The company's next-generation program VYD2311 showed promising Phase 1 results with 17-fold greater neutralization potency than pemivibart.
Invivyd (NASDAQ: IVVD) announced that PEMGARDA™ (pemivibart) maintains effective neutralizing activity against the currently dominant SARS-CoV-2 variant LP.8.1. The company's in vitro data demonstrates consistent neutralization against the three most prevalent U.S. variants: LP.8.1, XEC, and KP.3.1.1, as reported by the CDC.
PEMGARDA, authorized in the U.S. for pre-exposure prophylaxis of COVID-19 in immunocompromised patients, has shown stable neutralization activity since the Omicron BA.2 lineage. The company's next-generation candidate, VYD2311, also demonstrates effective neutralization against LP.8.1.
According to ACIP data presented, immunocompromised COVID-19 patients face:
- 2x higher likelihood of ICU admission
- 3x greater risk of requiring mechanical ventilation
- 4x higher hospital mortality rate