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 committed to the innovation, development, and commercialization of antibody-based therapies aimed at combating infectious diseases with pandemic potential. The company is primarily focused on developing antibodies that can provide superior protection against viral threats, starting with COVID-19.
Invivyd’s lead program, ADG20, is in clinical stages for both treatment and prevention of COVID-19, showcasing a broad spectrum of activity against various SARS-CoV-2 variants. Another promising candidate, VYD222, is engineered to ensure high potency and prolonged action in an evolving viral landscape. These efforts reflect Invivyd’s strategic approach of leveraging best-in-class antibody discovery capabilities to create multiple, non-competing antibodies with distinct targets, thereby minimizing the risk of viral escape.
In recent developments, Invivyd has achieved notable milestones including the receipt of Emergency Use Authorization (EUA) for PEMGARDA™ (pemivibart) for the pre-exposure prophylaxis of COVID-19 in moderately to severely immunocompromised individuals. PEMGARDA is the first mAb to receive EUA utilizing a rapid immunobridging trial design, indicating its potential to meet urgent medical needs. The company is positioned to launch PEMGARDA in the U.S., targeting key healthcare practitioners and institutions caring for high-risk populations.
The company’s proprietary INVYMAB™ platform integrates advanced viral surveillance, predictive modeling, and antibody engineering to generate new monoclonal antibodies (mAbs) swiftly and serially. This approach ensures that Invivyd remains at the forefront of addressing evolving viral threats. In addition to PEMGARDA, Invivyd is planning to advance VYD2311 into clinical development, further expanding its innovative pipeline.
Financially, Invivyd has projected a robust performance with net product revenue guidance for PEMGARDA ranging from $150 million to $200 million for the full year 2024. The company’s recent strategic review has optimized operational efficiencies, improving the projected year-end cash position to at least $75 million. These financial strategies ensure that Invivyd is well-positioned to sustain its development efforts and commercial initiatives.
Looking ahead, Invivyd plans to seek authorization for PEMGARDA for the treatment of mild to moderate symptomatic COVID-19 in immunocompromised individuals using an aligned, rapid immunobridging pathway. This underscores the company’s mission to deliver effective antibody-based treatments that continually adapt to the changing viral landscape.
Overall, Invivyd, Inc. exemplifies a relentless commitment to protecting vulnerable populations from serious viral infections through pioneering therapeutic advancements and strategic financial stewardship.
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.
Invivyd (NASDAQ: IVVD) announced new in vitro neutralization data demonstrating continued effectiveness of PEMGARDA™ (pemivibart) against the dominant SARS-CoV-2 variant XEC. The data shows consistent neutralizing activity, similar to previously reported results for KP.3.1.1. According to CDC estimates, XEC and KP.3.1.1 together represented 69% of U.S. circulating variants as of December 21, 2024.
PEMGARDA has demonstrated positive neutralization activity against over 75% of currently circulating U.S. variants and all prior variants tested. The company has submitted these new data to the FDA, with an expected update to the PEMGARDA Fact Sheet for Healthcare Providers. The drug has shown antiviral activity against 39 distinct SARS-CoV-2 variants over almost three years of virus evolution, with minimal changes in neutralization activity compared to predecessor medicines like Evusheld™.
Invivyd reported Q3 2024 financial results with PEMGARDA™ net product revenue of $9.3 million, up from $2.3 million in Q2 2024. The company ended Q3 with $106.9 million in cash and expects to end 2024 with at least $65 million. The quarter saw a net loss of $60.7 million ($0.51 per share). R&D expenses increased to $57.9 million, while SG&A expenses remained stable at $13.0 million. The PEMGARDA Fact Sheet was updated to reflect neutralization activity against current COVID-19 variants, including KP.3, KP.3.1.1, and LB.1. The company initiated Phase 1 trials for VYD2311, their next-generation COVID-19 antibody.
The New England Journal of Medicine (NEJM) published a Letter to the Editor describing PEMGARDA™ (pemivibart)'s immunobridging emergency use authorization pathway and an updated correlate of protection curve for COVID-19 prevention. The letter highlights the FDA-designed approach for rapid development of monoclonal antibodies against evolving COVID-19 variants. Invivyd expressed disappointment regarding a separate NEJM letter from Columbia University's Ho Lab containing discordant data about pemivibart's effectiveness against KP.3.1.1 variant. The FDA maintains that PEMGARDA likely retains adequate neutralization activity against current U.S. SARS-CoV-2 variants, including KP.3.1.1, LB.1, KP.3, and KP.2.
Invivyd (Nasdaq: IVVD) announced two significant preprint publications regarding their CANOPY Phase 3 clinical trial of pemivibart for COVID-19 prevention. The first preprint on MedRxiv details long-term protection data, showing 84% risk reduction during active dosing and 64% risk reduction during months 7-12 after treatment cessation against various COVID-19 variants. The second preprint on BioRxiv introduces a novel methodology for predicting monoclonal antibody effectiveness against emerging variants. The CANOPY trial data supported PEMGARDA's emergency use authorization by the FDA for certain immunocompromised patients, with consistent safety profiles maintained throughout the study.
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