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 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.
Invivyd (Nasdaq: IVVD) has announced its participation in the upcoming Guggenheim Securities Healthcare Innovation Conference in Boston, MA. The company's management will engage in a fireside chat scheduled for Wednesday, November 13, 2024, at 2:30 PM ET, along with conducting one-on-one investor meetings during the conference, which runs from November 11-13, 2024.
A live webcast of the presentation will be accessible through the investor section of Invivyd's website and will remain available for approximately 30 days after the event.
Invivyd (Nasdaq: IVVD) has scheduled a conference call for November 14, 2024, at 8:30 a.m. ET to discuss its third quarter 2024 financial results and provide business updates. The company, which focuses on protection from serious viral infectious diseases, previously released preliminary Q3 2024 results on October 29, 2024. The webcast will include a Q&A session for analysts, who are advised to join 15 minutes early. A replay will be available on the company's investor relations website approximately two hours after the call ends.
Invivyd reported preliminary Q3 2024 results, with PEMGARDA™ net product revenue of $9.3 million and approximately $107 million in cash and equivalents. The company withdrew its previous guidance of $150-200 million in PEMGARDA revenue for 2024 due to growth headwinds from an FDA warning regarding reduced activity of pemivibart. The warning was based on contested, third-party data from a non-pemivibart antibody. Despite these challenges, Invivyd expects to finish 2024 with $65 million or more in cash and targets profitability in 1H 2025 through anticipated revenue growth and operational efficiencies.
Invivyd announced positive 12-month exploratory clinical efficacy data from their CANOPY Phase 3 trial of PEMGARDA™ (pemivibart) for COVID-19 pre-exposure prophylaxis. The data showed 76% overall protection over 12 months following two initial doses, with 84% relative risk reduction in the first 6 months and 64% protection during months 7-12 without additional doses. The trial included immunocompetent participants during the U.S. summer KP.3 and KP.3.1.1 dominant wave. The safety profile remained consistent with no new safety signals, though some participants experienced mild to moderate infusion-related reactions and rare cases of anaphylaxis were reported in Cohort A.
Invivyd (Nasdaq: IVVD) announced upcoming presentations of pemivibart data from its Phase 1 and Phase 3 clinical trials at IDWeek 2024 in Los Angeles, October 16-19, 2024. The presentations include:
- An oral presentation on clinical efficacy endpoints from the Phase 3 CANOPY Study
- A poster on results from a Phase 1 first-in-human study
- A poster on pharmacokinetics and serum virus neutralizing antibody titers following the 2nd dose in the Phase 3 CANOPY Trial
Robert Allen, Chief Scientific Officer at Invivyd, emphasized the importance of sharing this data as COVID-19 continues to pose a threat, particularly to immunocompromised individuals. The company will make the posters and presentation available on their website after the conference.
Invivyd (Nasdaq: IVVD) announced that the FDA has updated the Emergency Use Authorization (EUA) Fact Sheet for PEMGARDA™ (pemivibart) with accurate SARS-CoV-2 variant susceptibility data. The updated Fact Sheet, dated September 26, 2024, includes in vitro neutralization activity against dominant circulating variants, including KP.3.1.1 and LB.1, which is in line with prior variants represented in the CANOPY Phase 3 clinical trial.
The FDA removed a contested statement about reduced susceptibility to pemivibart for KP.3.1.1, based on data provided by LabCorp's Monogram Biosciences lab. Invivyd emphasizes the importance of relying on validated, scientific studies conducted with authentic pemivibart under industrial-quality conditions for assessing neutralization potency and variant susceptibility.
Invivyd, Inc. (Nasdaq: IVVD) has provided detailed virology data and analysis of SARS-CoV-2 structural biology, predicting anticipated neutralization activity for PEMGARDA™ (pemivibart). Key points include:
- Independent evaluation shows in vitro pseudovirus neutralization potency of PEMGARDA against KP.3.1.1 and LB.1 variants in-line with prior variants tested
- Ongoing SARS-CoV-2 spike analyses demonstrate consistent structural stability of the pemivibart binding site
- Potential emerging variants (XEC and LP.1) encode mutations distal from the pemivibart binding site, not expected to meaningfully alter activity
- Pemivibart potency against contemporary viruses remains in-line with predominant variants since 2022
- Structural analysis shows no meaningful mutational change in the pemivibart binding site since late 2021
The company's ongoing genetic and structural analyses provide the biological rationale for expected neutralization activity of pemivibart against evolving SARS-CoV-2 variants.
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