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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, Inc. (Nasdaq: IVVD) announces readiness to address the increasing COVID-19 cases with PEMGARDA™ (pemivibart), an FDA-authorized monoclonal antibody for pre-exposure prophylaxis in certain immunocompromised individuals. The CDC reports a continued rise in COVID-19 death rates throughout 2024, with immunocompromised patients at highest risk. PEMGARDA is covered by Medicare and Medicaid and has gained rapid commercial coverage across major health plans.
The Infectious Disease Society of America recommends PEMGARDA for PrEP in moderately to severely immunocompromised adults and adolescents at risk of severe COVID-19. Invivyd has launched a Patient Savings Program to assist eligible commercially insured patients. Recent data shows PEMGARDA's continued neutralizing activity against dominant SARS-CoV-2 variants KP.3.1.1 and LB.1. Invivyd is also developing VYD2311, a next-generation mAb candidate with promising early results.
Invivyd (Nasdaq: IVVD), a biopharmaceutical company focused on protection from serious viral infectious diseases, has announced its participation in three upcoming investor conferences in New York, NY:
- Morgan Stanley 22nd Annual Global Healthcare Conference on September 6, 2024, at 10:00 AM ET
- H.C. Wainwright 26th Annual Global Investment Conference on September 9, 2024, at 9:30 AM ET
- 2024 Cantor Global Healthcare Conference on September 18, 2024, at 10:55 AM ET
Live webcasts of the fireside chats will be available on Invivyd's investor website and archived for approximately 90 days after the events.
Invivyd (Nasdaq: IVVD) has initiated dosing in the Phase 1 clinical trial of VYD2311, a next-generation monoclonal antibody for COVID-19. This trial, conducted in Australia, will assess safety, tolerability, pharmacokinetics, and immunogenicity in healthy volunteers. VYD2311 has shown high in vitro neutralization potency against post-Omicron variants and will explore intramuscular administration for improved patient convenience.
The company expects preliminary data in Q4 2024, with additional clinical readouts throughout 2025. VYD2311 aims to build on the success of PEMGARDA™ (pemivibart), which recently received FDA Emergency Use Authorization for pre-exposure prophylaxis in certain immunocompromised patients.
Invivyd (IVVD) announces continued neutralizing activity of PEMGARDA™ (pemivibart) against dominant SARS-CoV-2 variants KP.3.1.1 and LB.1, as well as other variants of interest. New pseudovirus in vitro neutralization data show:
1. Continued effectiveness against KP.3.1.1, which accounts for 42.2% of circulating variants and is the only major variant increasing nationally.
2. Efficacy against variants containing key mutations like Q493E and S31 deletion.
3. Pemivibart's epitope remains intact across 99.59% of viral sequences since Omicron BA.1.
4. Pipeline candidate VYD2311 also shows promising neutralization potency.
Data submitted to FDA for potential updates to PEMGARDA™ Fact Sheet. This demonstrates Invivyd's ongoing efforts in developing variation-resistant COVID-19 antibody medicines.
Invivyd (Nasdaq: IVVD) announced positive 180-day exploratory clinical efficacy data from its ongoing CANOPY Phase 3 trial of pemivibart, an investigational monoclonal antibody for COVID-19 pre-exposure prophylaxis. In immunocompetent individuals, pemivibart demonstrated an 84% relative risk reduction in symptomatic COVID-19 compared to placebo. The pemivibart group had a 1.9% rate of confirmed symptomatic COVID-19, versus 11.9% in the placebo group. In immunocompromised participants, pemivibart showed a 3% rate of confirmed symptomatic COVID-19. The safety profile remained consistent with previous data. The FDA updated the PEMGARDA Fact Sheet for Healthcare Providers to include these exploratory clinical efficacy data.
Invivyd reported Q2 2024 financial results and business highlights for its COVID-19 antibody PEMGARDA. Key points include:
1. $2.3 million net product revenue from PEMGARDA's commercial launch
2. Accelerating commercial results in early Q3 2024
3. New Chief Commercial Officer, Tim Lee, appointed
4. Achieved Medicare, Medicaid, and commercial insurance coverage
5. Submitted EUA amendment for PEMGARDA treatment of mild-to-moderate COVID-19 in immunocompromised patients
6. VYD2311 first-in-human trial to begin in late August
7. $147.9 million in cash and cash equivalents at Q2 end
8. Projected 2024 year-end cash of at least $75 million
9. Anticipated 2024 net product revenue of $150-$200 million
Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company focused on protecting against serious viral infectious diseases, has announced a conference call scheduled for Wednesday, August 14, 2024, at 8:30 a.m. ET. The call will cover the company's financial results for the second quarter ended June 30, 2024, along with recent business highlights. Interested parties can register for the webcast through a provided link, while analysts who wish to participate in the Q&A session have a separate link available. A replay of the webcast will be accessible on Invivyd's investor website approximately two hours after the call concludes. Participants are advised to join 15 minutes before the start time.
Invivyd (Nasdaq: IVVD), a biopharmaceutical company, announced its inclusion in the Russell 2000® and Russell 3000® Indexes following the annual reconstitution. This is effective from today, July 1, 2024, at the opening of U.S. equity markets. Being part of the Russell 3000® Index means automatic inclusion in the large-cap Russell 1000® or small-cap Russell 2000® Index and relevant growth and value style indexes. The Russell 3000® Index includes the 3,000 largest U.S.-traded stocks based on market capitalization and style attributes. Membership in these indexes is reviewed annually and helps investment managers and institutional investors benchmark active investment strategies and manage index funds. The Russell indexes are maintained by FTSE Russell, a leading global index provider.
Invivyd announced that its investigational monoclonal antibody, VYD222 (pemivibart), shows continued in vitro neutralizing activity against the current dominant SARS-CoV-2 variants, KP.1.1 FLiRT and KP.3.
This data aligns with earlier findings from an independent lab. The next candidate, VYD2311, also shows similar neutralization activity. As of June 8, 2024, FLiRT variants account for over 50% of circulating SARS-CoV-2 sequences, with KP.3 expected to become the most dominant strain.
Invivyd uses proprietary software, VivydTools, to track and monitor virus variations. The company notes the stability of the VYD222 epitope and is committed to ongoing assessment.
Invivyd (Nasdaq: IVVD), a biopharmaceutical company focused on viral infectious diseases, announced its participation in the Jefferies Global Healthcare Conference on June 6, 2024, at 3:00 p.m. ET in New York. The company will engage in a fireside chat and host investor meetings. A live webcast of the chat will be available on Invivyd's investor website and archived for 30 days.
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