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 clinical-stage biopharmaceutical company pioneering monoclonal antibody (mAb) therapies to combat evolving viral threats like COVID-19. This page provides investors and stakeholders with timely updates on Invivyd’s regulatory milestones, clinical trial progress, and strategic initiatives.
Discover the latest developments for PEMGARDA™, Invivyd’s EUA-authorized pre-exposure prophylaxis, and next-generation candidates like VYD2311. Our news collection covers critical updates including FDA communications, partnership announcements, and peer-reviewed data publications. All content is vetted for accuracy and relevance to ensure you stay informed on Invivyd’s progress in protecting immunocompromised populations.
Key focus areas include advancements from the proprietary INVYMAB™ platform, trial results demonstrating variant resistance, and manufacturing scalability updates. Bookmark this page for direct access to press releases, earnings call summaries, and analyses of Invivyd’s role in infectious disease innovation.
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
Invivyd (NASDAQ: IVVD) announced that the FDA declined their request to expand PEMGARDA™ (pemivibart) Emergency Use Authorization (EUA) to include treatment of mild-to-moderate COVID-19 in immunocompromised patients. The FDA's decision was based on the requirement that monoclonal antibodies must demonstrate superior, rather than equivalent, antiviral activity compared to previously authorized antibodies.
The company's submission showed comparable antiviral activity between pemivibart and adintrevimab, with predicted clinical efficacy above currently authorized convalescent plasma. The existing PEMGARDA EUA for pre-exposure prophylaxis of COVID-19 in certain immunocompromised patients remains unchanged.
Invivyd plans to advance VYD2311 in collaboration with FDA, addressing the ongoing COVID-19 burden. The company noted that the COVID-19 treatment opportunity for pemivibart was not included in existing financial guidance.
Invivyd (Nasdaq: IVVD) has announced its participation in the Oppenheimer 35th Annual Healthcare Life Sciences Conference. Marc Elia, Chairman of the Invivyd Board of Directors, will deliver a presentation on Wednesday, February 12th, 2025 at 1:20 PM ET.
The presentation will be accessible via live webcast through the investor section of Invivyd's website at investors.invivyd.com. The recording will remain available for approximately 90 days after the event.
Invivyd (Nasdaq: IVVD) has announced a strategic partnership with professional football coach Jim Harbaugh to raise awareness about the ongoing impact of COVID-19. The initiative focuses on highlighting that COVID-19 remains a significant health concern, causing approximately one American death every 9 minutes, with about 59,000 deaths and 665,000 hospitalizations in 2024, despite widespread vaccination.
The partnership aims to educate the public, especially immunocompromised individuals such as cancer patients and organ transplant recipients, about COVID-19's short and potential long-term risks. Recent data shows increasing ICU admission rates for COVID-19 hospitalizations, and research suggests the long-term health and economic burden may exceed several other chronic diseases.
Through live and social media initiatives, Coach Harbaugh will help promote awareness and encourage people to learn more about available options beyond vaccines at www.expandtheiroptions.com. The campaign emphasizes that while COVID-19 is common, it should not be dismissed as merely a cold.
Invivyd (NASDAQ: IVVD) announced positive Phase 1/2 clinical trial data for VYD2311, a monoclonal antibody designed as an alternative to COVID-19 vaccination. The trial, involving 40 subjects across multiple administration routes, showed promising results in both safety and pharmacokinetics.
Key findings include:
- Mild to moderate adverse events, mainly to injection site reactions
- High serum concentrations maintained through Day 65
- 17-fold greater neutralization potency compared to pemivibart
- Potential for 70-90% protection from symptomatic COVID-19
- Possibility of once or twice-annual dosing
The data suggests VYD2311 could offer superior efficacy, safety, and durability compared to current COVID-19 vaccines, while also serving as a potential treatment option. The company completed recruitment and dosing, with only long-term follow-up remaining.
Invivyd (IVVD) announced preliminary Q4 2024 financial results, showing strong growth with PEMGARDA™ net product revenue of $13.8 million, a 48% increase from Q3 2024's $9.3 million. The company significantly reduced operating costs to $32 million in Q4, down 55% from Q3's $71.6 million, primarily through manufacturing expense reductions.
The company ended 2024 with $69.3 million in cash and cash equivalents plus $10.9 million in accounts receivable. Invivyd expects minimal manufacturing expenses in 2025, as VYD2311 commercial manufacturing was completed in 2024 to support up to one million doses. The company maintains its target for near-term profitability by the end of 1H 2025, supported by existing cash, anticipated revenue growth, and continued cost reductions.
Invivyd (NASDAQ: IVVD) has submitted an updated immunobridging analysis to the FDA supporting its request to expand PEMGARDA™ (pemivibart) Emergency Use Authorization (EUA) to include treatment of mild-to-moderate COVID-19 in certain immunocompromised patients. The analysis demonstrates that pemivibart shows substantially higher antiviral titers in the early phase post-dosing compared to adintrevimab, which previously showed 66-74% reduction in hospitalization or death risk.
PEMGARDA received initial EUA in March 2024 for pre-exposure prophylaxis of COVID-19 in immunocompromised individuals. The updated analysis incorporates data from the dominant SARS-CoV-2 variant XEC and builds upon multiple analyses submitted since July 2024. Notably, no additional anaphylaxis cases have been reported during post-authorization use, following the four cases observed in the CANOPY Phase 3 trial.
